etanercept
DrugEtanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
Other names: Enbrel
NCT Number: NCT00962741
This study will evaluate the effect of etanercept on the clinical benefit, safety, and physical functioning (ability to function in daily life) in children and adolescent subjects with 3 subtypes of childhood arthritis.
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Notify Me2 year–17 year
All sexes
Interventional
Phase 3
Pfizer Investigational Site, Westmead, Sydney, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
Other names: Enbrel
Time frame: Week 12
ACR Pedi 30 response: greater than or equal to (>=) 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) childhood health assessment questionnaire (CHAQ) 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
Time frame: Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66*(total number of tender entheses with counts > 0)/number of non-missing tender entheses. If > 33 tender entheseal counts were missing, total number of tender entheses was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Modified Schober's Test: A mark was placed in the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 centimeter (cm) above the first. The participant then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb= 1 percent (%) of BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck= 10% (10 palms), upper extremities= 20% (20 palms), Trunk (axillae and groin)= 30% (30 palms), lower extremities (buttocks)= 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5. 0 (no psoriasis) to 5 (severe disease). 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1.
Time frame: Week 12, Week 96
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.
Time frame: Week 12, Week 96
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.
Time frame: Week 12, Week 96
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.
Time frame: Week 12, Week 96
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.
Time frame: Baseline, Week 12, Week 48, Week 96
Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).
Time frame: Baseline, Week 12, Week 48, Week 96
Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).
Time frame: Baseline, Week 12, Week 48, Week 96
Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).
Time frame: Baseline, Week 12, Week 48, Week 96
Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).
Time frame: Baseline, Week 12, Week 48, Week 72, Week 96
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Time frame: Baseline, Week 12, Week 48, Week 72, Week 96
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Time frame: Baseline, Week 12, Week 48, Week 72, Week 96
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Time frame: Baseline, Week 12, Week 48, Week 72, Week 96
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Time frame: Baseline, Week 12, Week 48, Week 72, Week 96
BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Time frame: Baseline, Week 12, Week 48, Week 72, Week 96
BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Time frame: Baseline, Week 12, Week 48, Week 72, Week 96
BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Time frame: Baseline, Week 12, Week 48, Week 72, Week 96
BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Time frame: Baseline up to Week 12, Week 48, Week 96
Time frame: Baseline up to Week 12, Week 48, Week 96
Time frame: Baseline up to Week 12, Week 48, Week 96
Time frame: Baseline up to Week 12, Week 48, Week 96
Time frame: Baseline up to Week 12, Week 48, Week 96
Pfizer
Industry
A 2-Part Open-Label Study to Assess the Clinical Benefit and Long-Term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis
Acronym: CLIPPER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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