Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis

Parameters: Hematology (hemoglobin, hematocrit, erythrocytes, platelets, leukocytes, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, prothrombin international normalized ratio, erythrocyte sedimentation rate), clinical chemistry (bilirubin, direct/indirect bilirubin, aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, cholesterol, high and low density lipoprotein cholesterol, Friedewald estimation, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, C reactive protein), urinalysis (specific gravity, potential of hydrogen (pH), glucose/ protein/ hemoglobin/ erythrocytes/ leukocytes, ketones, leukocyte esterase, hyaline casts, bacteria). Number of participants with at least 1 laboratory abnormality are reported.

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A serious AE (SAE) was defined as any untoward medical occurrence at any dose that met one or more of the following criteria: resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. An TEAE was any AE that occurred following the start of study treatment in this study or increased in severity following the start of study treatment in this study. AE included both SAEs and all non-SAEs.

Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).

Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).

Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).

Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).

Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).

Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).

Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).

Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).

Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).

Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).

Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).

Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).

Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).

Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).

Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).

Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).

Pubertal development was measured using Tanner stage, by age group (2 to <6 years, 6 to <12 years, and 12 years or older) for males and females separately. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (fully developed breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes continue to enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size).

Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 12. Only rows with non-zero values were reported in this outcome measure.

Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 24. Only rows with non-zero values were reported in this outcome measure.

Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 36. Only rows with non-zero values were reported in this outcome measure.

Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 48. Only rows with non-zero values were reported in this outcome measure.

Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 60. Only rows with non-zero values were reported in this outcome measure.

Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 72. Only rows with non-zero values were reported in this outcome measure.

Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 84. Only rows with non-zero values were reported in this outcome measure.

Physician global evaluation of disease activity assessed overall arthritis appearance at specified time points. The evaluation was based on the participant's disease signs, functional capacity and physical examination. The investigator rated the overall level of disease activity by entering a number from 0 (no disease activity) to 10 (maximum disease activity) on a visual analogue scale (VAS). Higher scores signified more disease activity.

Physician global evaluation of disease activity assessed overall arthritis appearance at specified time points. The evaluation was based on the participant's disease signs, functional capacity and physical examination. The investigator rated the overall level of disease activity by entering a number from 0 (no disease activity) to 10 (maximum disease activity) on a VAS. Higher scores signified more disease activity.

Physician global evaluation of disease activity assessed overall arthritis appearance at specified time points. The evaluation was based on the participant's disease signs, functional capacity and physical examination. The investigator rated the overall level of disease activity by entering a number from 0 (no disease activity) to 10 (maximum disease activity) on a VAS. Higher scores signified more disease activity. In this outcome measure pJIA stands for polyarticular course juvenile idiopathic arthritis.

Physician global evaluation of disease activity assessed overall arthritis appearance at specified time points. The evaluation was based on the participant's disease signs, functional capacity and physical examination. The investigator rated the overall level of disease activity by entering a number from 0 (no disease activity) to 10 (maximum disease activity) on a VAS. Higher scores signified more disease activity.

Physician global evaluation of disease activity assessed overall arthritis appearance at specified time points. The evaluation was based on the participant's disease signs, functional capacity and physical examination. The investigator rated the overall level of disease activity by entering a number from 0 (no disease activity) to 10 (maximum disease activity) on a VAS. Higher scores signified more disease activity.

Active arthritis was defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion, or tenderness not due to deformity.

Active arthritis was defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion, or tenderness not due to deformity.

Active arthritis was defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion, or tenderness not due to deformity.

Active arthritis was defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion, or tenderness not due to deformity.

Active arthritis was defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion, or tenderness not due to deformity.

CRP was a laboratory measurement test for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation.

CRP was a laboratory measurement test for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation.

CRP was a laboratory measurement test for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation.

CRP was a laboratory measurement test for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation.

CRP was a laboratory measurement test for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation.

ESR was a laboratory test that provides a measure of inflammation. A higher rate is consistent with inflammation.

ESR was a laboratory test that provides a measure of inflammation. A higher rate is consistent with inflammation.

ESR was a laboratory test that provides a measure of inflammation. A higher rate is consistent with inflammation.

ESR was a laboratory test that provides a measure of inflammation. A higher rate is consistent with inflammation.

ESR was a laboratory test that provides a measure of inflammation. A higher rate is consistent with inflammation.

CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. Disability index assessed function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed among a total of 30 items. Each question was rated from Grade 0 to 3, 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, 3= unable to do. If aids or devices were used or assistance was required, the minimum score for that functional area was 2. Parent/legal guardians were required to answer all questions. The disability index was calculated as the mean of the 8 functional areas and scores were averaged to calculate CHAQ disability index, which ranged from 0= no/minimal physical dysfunction to 3= very severe physical dysfunction; higher score indicated more disability.

CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. Disability index assessed function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed among a total of 30 items. Each question was rated from Grade 0 to 3, 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, 3= unable to do. If aids or devices were used or assistance was required, the minimum score for that functional area was 2. Parent/legal guardians were required to answer all questions. The disability index was calculated as the mean of the 8 functional areas and scores were averaged to calculate CHAQ disability index, which ranged from 0= no/minimal physical dysfunction to 3= very severe physical dysfunction; higher score indicated more disability.

CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. Disability index assessed function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed among a total of 30 items. Each question was rated from Grade 0 to 3, 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, 3= unable to do. If aids or devices were used or assistance was required, the minimum score for that functional area was 2. Parent/legal guardians were required to answer all questions. The disability index was calculated as the mean of the 8 functional areas and scores were averaged to calculate CHAQ disability index, which ranged from 0= no/minimal physical dysfunction to 3= very severe physical dysfunction; higher score indicated more disability.

CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. Disability index assessed function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed among a total of 30 items. Each question was rated from Grade 0 to 3, 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, 3= unable to do. If aids or devices were used or assistance was required, the minimum score for that functional area was 2. Parent/legal guardians were required to answer all questions. The disability index was calculated as the mean of the 8 functional areas and scores were averaged to calculate CHAQ disability index, which ranged from 0= no/minimal physical dysfunction to 3= very severe physical dysfunction; higher score indicated more disability.

CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. Disability index assessed function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed among a total of 30 items. Each question was rated from Grade 0 to 3, 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, 3= unable to do. If aids or devices were used or assistance was required, the minimum score for that functional area was 2. Parent/legal guardians were required to answer all questions. The disability index was calculated as the mean of the 8 functional areas and scores were averaged to calculate CHAQ disability index, which ranged from 0= no/minimal physical dysfunction to 3= very severe physical dysfunction; higher score indicated more disability.

CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For the assessment of discomfort index, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall arthritis pain of participant from 0 (no pain) to 10 (very severe pain), on a VAS, where higher scores indicated more severe pain.

CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For the assessment of discomfort index, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall arthritis pain of participant from 0 (no pain) to 10 (very severe pain), on a VAS, where higher scores indicated more severe pain.

CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For the assessment of discomfort index, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall arthritis pain of participant from 0 (no pain) to 10 (very severe pain), on a VAS, where higher scores indicated more severe pain.

CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For the assessment of discomfort index, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall arthritis pain of participant from 0 (no pain) to 10 (very severe pain), on a VAS, where higher scores indicated more severe pain.

CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For the assessment of discomfort index, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall arthritis pain of participant from 0 (no pain) to 10 (very severe pain), on a VAS, where higher scores indicated more severe pain.

CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For assessment of parent global assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being from 0 (very well) to 10 (very poor) on a VAS, where higher score indicated poor well-being.

CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For assessment of parent global assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being from 0 (very well) to 10 (very poor) on a VAS, where higher score indicated poor well-being.

CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For assessment of parent global assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being from 0 (very well) to 10 (very poor) on a VAS, where higher score indicated poor well-being.

CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For assessment of parent global assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being from 0 (very well) to 10 (very poor) on a VAS, where higher score indicated poor well-being.

CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For assessment of parent global assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being from 0 (very well) to 10 (very poor) on a VAS, where higher score indicated poor well-being.

JIA ACR 30 response was defined as follows: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.

JIA ACR 30 response was defined as follows: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.

JIA ACR 30 response was defined as follows: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.

JIA ACR 30 response was defined as follows: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.

JIA ACR 30 response was defined as follows: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.

JIA ACR 50 response was defined as follows: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.

JIA ACR 50 response was defined as follows: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.

JIA ACR 50 response was defined as follows: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.

JIA ACR 50 response was defined as follows: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.

JIA ACR 50 response was defined as follows: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.

JIA ACR 70 response was defined as follows: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.

JIA ACR 70 response was defined as follows: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.

JIA ACR 70 response was defined as follows: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.

JIA ACR 70 response was defined as follows: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.

JIA ACR 70 response was defined as follows: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.

JIA ACR 90 response was defined as follows: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.

JIA ACR 90 response was defined as follows: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.

JIA ACR 90 response was defined as follows: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.

JIA ACR 90 response was defined as follows: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.

JIA ACR 90 response was defined as follows: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.

JIA ACR 100 response was defined as follows: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.

JIA ACR 100 response was defined as follows: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.

JIA ACR 100 response was defined as follows: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.

JIA ACR 100 response was defined as follows: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.

JIA ACR 100 response was defined as follows: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.

Disease flare: worsening of >=30% in 3 or more of 6 variables of JIA core set, with no more than 1 variable improved by >=30%. Variables: 1) Physician global evaluation of disease activity (0= no disease activity - 10= maximum disease activity), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0= very well - 10= very poor), 5) Functional ability using disability index from CHAQ (0= very well - 10= very poor), 6) ESR. Fare definition: for number of active joints or joints with limited range of motion: at least 2 joints must have worsened; for physician's or parent/legal guardian global rating scores: at least 2 units worsening on 10-unit scale; for ESR: 2nd value for ESR in calculation >upper limit of normal. Participants with sJIA: might include recurrence of fever due to sJIA >38 degree Celsius(C) oral or >38.6 degree C rectal on >=2 consecutive days.

Disease flare: worsening of >=30% in 3 or more of 6 variables of JIA core set, with no more than 1 variable improved by >=30%. Variables: 1) Physician global evaluation of disease activity (0= no disease activity - 10= maximum disease activity), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0= very well - 10= very poor), 5) Functional ability using disability index from CHAQ (0= very well - 10= very poor), 6) ESR. Fare definition: for number of active joints or joints with limited range of motion: at least 2 joints must have worsened; for physician's or parent/legal guardian global rating scores: at least 2 units worsening on 10-unit scale; for ESR: 2nd value for ESR in calculation >upper limit of normal. Participants with sJIA: might include recurrence of fever due to sJIA >38 degree C oral or >38.6 degree C rectal on >=2 consecutive days.

Disease flare: worsening of >=30% in 3 or more of 6 variables of JIA core set, with no more than 1 variable improved by >=30%. Variables: 1) Physician global evaluation of disease activity (0= no disease activity - 10= maximum disease activity), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0= very well - 10= very poor), 5) Functional ability using disability index from CHAQ (0= very well - 10= very poor), 6) ESR. Fare definition: for number of active joints or joints with limited range of motion: at least 2 joints must have worsened; for physician's or parent/legal guardian global rating scores: at least 2 units worsening on 10-unit scale; for ESR: 2nd value for ESR in calculation >upper limit of normal.

Disease flare: worsening of >=30% in 3 or more of 6 variables of JIA core set, with no more than 1 variable improved by >=30%. Variables: 1) Physician global evaluation of disease activity (0= no disease activity - 10= maximum disease activity), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0= very well - 10= very poor), 5) Functional ability using disability index from CHAQ (0= very well - 10= very poor), 6) ESR. Fare definition: for number of active joints or joints with limited range of motion: at least 2 joints must have worsened; for physician's or parent/legal guardian global rating scores: at least 2 units worsening on 10-unit scale; for ESR: 2nd value for ESR in calculation >upper limit of normal.

Disease flare: worsening of >=30% in 3 or more of 6 variables of JIA core set, with no more than 1 variable improved by >=30%. Variables: 1) Physician global evaluation of disease activity (0= no disease activity - 10= maximum disease activity), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0= very well - 10= very poor), 5) Functional ability using disability index from CHAQ (0= very well - 10= very poor), 6) ESR. Fare definition: for number of active joints or joints with limited range of motion: at least 2 joints must have worsened; for physician's or parent/legal guardian global rating scores: at least 2 units worsening on 10-unit scale; for ESR: 2nd value for ESR in calculation >upper limit of normal.

JIA ACR clinical inactive disease status was defined as achieving all the following criteria: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; ESR or CRP within the normal reference range for the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes.

JIA ACR clinical inactive disease status was defined as achieving all the following criteria: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; ESR or CRP within the normal reference range for the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes.

JIA ACR clinical inactive disease status was defined as achieving all the following criteria: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; ESR or CRP within the normal reference range for the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes.

JIA ACR clinical inactive disease status was defined as achieving all the following criteria: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; ESR or CRP within the normal reference range for the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes.

JIA ACR clinical inactive disease status was defined as achieving all the following criteria: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; ESR or CRP within the normal reference range for the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes.

JIA ACR clinical remission was defined as inactive disease for 6 months (24 weeks) continuously while on medications. Clinical inactive disease status determination assessment was a derived measurement, which includes: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis (as defined by the standardization of uveitis nomenclature [SUN] working group); ESR or CRP levels within normal limits in the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes. At each time point, percentage of participants achieving clinical remission for the first time is reported.

JIA ACR clinical remission was defined as inactive disease for 6 months (24 weeks) continuously while on medications. Clinical inactive disease status determination assessment was a derived measurement, which includes: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis (as defined by the SUN working group); ESR or CRP levels within normal limits in the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes. At each time point, percentage of participants achieving clinical remission for the first time is reported.

JIA ACR clinical remission was defined as inactive disease for 6 months (24 weeks) continuously while on medications. Clinical inactive disease status determination assessment was a derived measurement, which includes: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis (as defined by the SUN working group); ESR or CRP levels within normal limits in the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes. At each time point, percentage of participants achieving clinical remission for the first time is reported.

JIA ACR clinical remission was defined as inactive disease for 6 months (24 weeks) continuously while on medications. Clinical inactive disease status determination assessment was a derived measurement, which includes: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis (as defined by the SUN working group); ESR or CRP levels within normal limits in the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes. At each time point, percentage of participants achieving clinical remission for the first time is reported.

JIA ACR clinical remission was defined as inactive disease for 6 months (24 weeks) continuously while on medications. Clinical inactive disease status determination assessment was a derived measurement, which includes: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis (as defined by the SUN working group); ESR or CRP levels within normal limits in the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes. At each time point, percentage of participants achieving clinical remission for the first time is reported.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease(27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). Overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of:<=3.8. For participants with oligoarthritis (<=4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=2.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease(27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). Overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of:<=3.8. For participants with oligoarthritis (<=4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=2.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease(27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). Overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of:<=3.8. For participants with oligoarthritis (<=4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=2.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease(27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). Overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of:<=3.8. For participants with oligoarthritis (<=4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=2.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease(27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). Overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of:<=3.8. For participants with oligoarthritis (<=4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=2.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1. For participants with oligoarthritis (<=4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1. For participants with oligoarthritis (<=4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1. For participants with oligoarthritis (<=4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1. For participants with oligoarthritis (<=4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1.

JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1. For participants with oligoarthritis (<=4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1.

Participants with inactive disease for at least 24 consecutive weeks began to taper off concomitant JIA therapies and tofacitinib. Tapering of therapies was completed in the following order: oral corticosteroids, methotrexate (MTX)/leflunomide, tofacitinib. A participant had multiple taperings with different results per medication and the best tapering result per medication per participant is summarized in this outcome measure. Participants achieving eligibility of tapering = participants who took the drug and started tapering; participants achieving partial tapering = participants who were able to undergo tapering from one dose level to a lower dose level; participants achieving complete tapering = participants discontinued drug completely.

Participants with inactive disease for at least 24 consecutive weeks began to taper off concomitant JIA therapies and tofacitinib. Tapering of therapies was completed in the following order: oral corticosteroids, MTX/leflunomide, tofacitinib. A participant had multiple taperings with different results per medication and the best tapering result per medication per participant is summarized in this outcome measure. Participants achieving eligibility of tapering = participants who took the drug and started tapering; participants achieving partial tapering = participants who were able to undergo tapering from one dose level to a lower dose level; participants achieving complete tapering = participants discontinued drug completely.

Participants with inactive disease for at least 24 consecutive weeks began to taper off concomitant JIA therapies and tofacitinib. Tapering of therapies was completed in the following order: oral corticosteroids, MTX/leflunomide, tofacitinib. A participant had multiple taperings with different results per medication and the best tapering result per medication per participant is summarized in this outcome measure. Participants achieving eligibility of tapering = participants who took the drug and started tapering; participants achieving partial tapering = participants who were able to undergo tapering from one dose level to a lower dose level; participants achieving complete tapering = participants discontinued drug completely.

Participants with inactive disease for at least 24 consecutive weeks began to taper off concomitant JIA therapies and tofacitinib. Tapering of therapies was completed in the following order: oral corticosteroids, MTX/leflunomide, tofacitinib. A participant had multiple taperings with different results per medication and the best tapering result per medication per participant is summarized in this outcome measure. Participants achieving eligibility of tapering = participants who took the drug and started tapering; participants achieving partial tapering = participants who were able to undergo tapering from one dose level to a lower dose level; participants achieving complete tapering = participants discontinued drug completely.

Participants with inactive disease for at least 24 consecutive weeks began to taper off concomitant JIA therapies and tofacitinib. Tapering of therapies was completed in the following order: oral corticosteroids, MTX/leflunomide, tofacitinib. A participant had multiple taperings with different results per medication and the best tapering result per medication per participant is summarized in this outcome measure. Participants achieving eligibility of tapering = participants who took the drug and started tapering; participants achieving partial tapering = participants who were able to undergo tapering from one dose level to a lower dose level; participants achieving complete tapering = participants discontinued drug completely.

Absence of fever was defined as absence of fever due to sJIA in the week preceding the assessment at each visit. Fever was defined as temperature >38 C/ 100.4 F (oral) or >101.4 F/38.6 C (rectal), due to sJIA, in the last 7 days before the visit.

Absence of fever was defined as absence of fever due to sJIA in the week preceding the assessment at each visit. Fever was defined as temperature >38 C/ 100.4 F (oral) or >101.4 F/38.6 C (rectal), due to sJIA, in the last 7 days before the visit.

Tender entheseal assessment was performed by the investigator as 'Yes' or 'No'. 'Yes' indicated the presence of tenderness upon firm palpation over the specified enthesis and 'No' indicated the absence of tenderness upon firm palpation over the indicated enthesis. A total of 16 entheseal sites were assessed and the number of tender sites was counted. The score ranges from 0 to 16, where 0 represents the best possible outcome (no tenderness) and 16 represents the worst possible outcome (maximum tenderness).

Modified Schober's test was performed at the study visits only in participants with enthesitis-related arthritis. With the participant standing erect and with feet together, a line joining the posterior superior iliac spines (the dimples of Venus) was used as a landmark for the lumbosacral junction. A mark was made 5 centimeters (cm) below and 10 cm above the lumbosacral junction. With the participant in maximum forward flexion with the knees straight, the investigator measures the distance between the two marks in centimeters. The full measurement between the two lines was recorded to the nearest tenth of a centimeter (e.g., 15.2 cm) on the appropriate CRF.

Severity of overall back pain (at any time) experienced was rated by parent/legal guardian/participant on a VAS from 0 (no pain) to 10 (most severe pain), where higher score indicated more severe pain.

Severity of nocturnal back pain (at night) experienced was rated by parent/legal guardian/participant on a VAS from 0 (no pain) to 10 (most severe pain), where higher score indicated more severe pain.

BSA was measured as the percentage of BSA affected by psoriasis using the palm method; the participants palm was used for the calculation. One of the participant's palm to proximal interphalangeal (PIP) and thumb equals to 1% of BSA. Regions of the body included along with percentage of BSA: 1) head and neck = 10% (10 palms); 2) upper extremities = 20% (20 palms); 3) trunk (axillae and groin) = 30% (30 palms) and 4) lower extremities (buttocks) = 40% (40 palms).Total BSA was sum of all regions ranged from 0% to 100% (100 palms). The physician assessed the total BSA affected by psoriasis using the addition of the individual regions.

PGA was used to determine participant's overall psoriasis lesions at a given time point. Overall lesions were graded for induration, erythema, and scaling based upon scales. Induration scale ranged from: 0 (no evidence of plaque elevation) to 5 (severe plaque elevation or more); erythema scale ranged from: 0 (no evidence of erythema, hyper pigmentation may be present) to 5 (dusky to deep red coloration); scaling scale ranged from: 0 (no evidence of scaling) to 5 (severe; very thick tenacious scale predominates). Total PGA score was calculated based on sum of 3 scales divided by 3 to obtain final PGA, ranging from 0 (no evidence) to 5 (maximum severity); higher scores indicated more severity of psoriasis.