secukinumab
OtherProspective observational study. There is no treatment allocation. Patients who are receiving or intend to receive secukinumab are eligible to enroll into this study.
NCT Number: NCT05155098
This is an observational, prospective primary data collection study. The duration of observation is 2 years after study enrolment date. Disease and treatment history will be retrospectively reviewed from medical record at enrollment with no time limits for the key diagnosis of enrolment (plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthropathy).
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Notify Me18 year–80 year
All sexes
Observational
Novartis Investigative Site, Songkhla, Hat Yai, Thailand
After the baseline visit, data will be collected for each patient prospectively every 6 months for up to 2 years. At each visit, effectiveness parameters, as well as the patients' QoL and treatment pattern will be documented.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prospective observational study. There is no treatment allocation. Patients who are receiving or intend to receive secukinumab are eligible to enroll into this study.
Time frame: 2 years
Retention rate is defined as percentage of patients who have not discontinued the medication.
Time frame: year 1, year 2
Retention rate is defined as percentage of patients who have not discontinued the medication.
Time frame: Baseline, month 6, month 12, month 18, month 24
Euro-QoL-5 Dimension Questionnaire (EQ-5D) is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions.
Time frame: Month 6, month 12, month 18, month 24
Proportion of patients for each indication with alterations of secukinumab treatment regimen and reasons for.
Time frame: 2 years
Number of days of absenteeism from work/school due to health condition during each visit. Health condition which is considered to be related to the absenteeism will be determined by the treating physicians on the relationship with psoriasis, psoriatic arthritis or non-radiographic axial SpA or others conditions.
Time frame: Month 6, month 12, month 18, month 24
Psoriasis Area and Severity Index (PASI) takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis.
Time frame: 2 Years
Changes between PASI response categories over time after starting participation in the study to be collected.
Time frame: Month 6, month 12, month 18, month 24
Absolute PASI scores to be collected
Time frame: Baseline, month 6, month 12, month 18, month 24
Relative PASI, also called PASI response, is reported as a percent change from baseline PASI.
Absolute PASI is reported as a score to reflect the current status of severity of disease.
Time frame: Month 6, month 12, month 18, month 24
Physician Global Assessment (PGA) 0/1 response = clear/almost clear skin
Time frame: Month 6, month 12, month 18, month 24
Dermatology Life Quality Index (DLQI) is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such psoriasis. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) 1 ( a little) to 3 (very much). "Not relevant" is a valid score also and is scored as 0.
Time frame: 2 years
Correlation analysis will be performed using Pearson's correlation or Spearman's correlation, depending on normality.
Time frame: 1 year, 2 years
78 tender joint count (TJC) is determined by physical examination of 78 joint counts that are assessed for tenderness.
76 swollen joint count (SJC) is determined by physical examination of 76 joint counts that are classified as either swollen or not swollen.
Time frame: 1 year, 2 years
VAS scale will be used to measure disease activity. The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
Time frame: 1 year, 2 years
The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
Time frame: 1 year, 2 years
Dactylitis is severe inflammation of the finger and toe joints.
Time frame: 1 year, 2 years
Presence of any enthesitis in the following sites: lateral epicondyle humerus left and right, Achilles left and right and medial condyle femur left and right.
Enthesitis refers to inflammation of entheses, the site where ligaments or tendons insert into the bones.
Time frame: 1 year, 2 years
Appearance of new bone erosions or worsening of pre-existing erosions in the hands and feet by X-ray assessment, according to the Treating Physician's opinion
Time frame: month 6, month 12, month 18 and month 24
Psoriasis Area and Severity Index (PASI) takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis.
Time frame: 2 years
Changes between PASI response categories over time after starting participation in the study
Time frame: month 6, month 12, month 18 and month 24
Absolute PASI scores to be collected
Time frame: 2 years
Changes in absolute and relative PASI scores over time after inclusion into the study.
Time frame: month 6, month 12, month 18 and month 24
Health Assessment Questionnaire Disability Index (HAQ-DI) assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.(Only at sites where HAQ-DI score is part of clinical routine).
Time frame: month 6, month 12, month 18 and month 24
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) assesses self-reported fatigue and its impact upon daily activities and function.
FACIT-Fatigue Scale: overall score (0 to 52)=the sum of scores for 13 questions. For each question, par. rated their condition for the past week on a 5-point scale: 0 (not at all) to 4 (very much). A high score indicates low fatigue.
(Only at sites where FACIT-Fatigue score is part of clinical routine).
Time frame: 2 years
Correlation analysis will be performed using Pearson's correlation or Spearman's correlation, depending on normality.
Time frame: year 1, year 2
BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to ankylosing spondylitis: 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10. Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe symptoms.
Time frame: year 1, year 2
Patient's global assessment of disease activity will be measured using VAS scale or NRS (numeric rating scale). NRS scale goes from 0 to 10 (0= no activity, 10= activity)
Time frame: year 1, year 2
CRP or high-sensitivity CRP to be collected
Time frame: year 1, year 2
The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
Time frame: 2 years
Presence of any enthesitis in the following sites:
Time frame: year 1, year 2
Appearance or worsening, according to the treating physician's opinion, of any of the following lesions at anterior sites of the vertebrae assessed by X-ray (when available):
Time frame: year 1, year 2
Appearance or worsening (according to the Treating Physician's opinion) of bone marrow edema (BME) in the spine and/or sacro-iliac joints assessed by magnetic resonance imaging (MRI) (when available).
Time frame: month 6, month 12, month 18 and month 24
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) assesses self-reported fatigue and its impact upon daily activities and function.
FACIT-Fatigue Scale: overall score (0 to 52)=the sum of scores for 13 questions. For each question, par. rated their condition for the past week on a 5-point scale: 0 (not at all) to 4 (very much). A high score indicates low fatigue.
Time frame: 2 years
Data from BASDAI, patient's global assessment (NRS) and CRP/hsCRP can be used to calculate the AS disease activity score (ASDAS).
Correlation analysis will be performed using Pearson's correlation or Spearman's correlation, depending on normality.
Novartis Pharmaceuticals
Industry
2 Years Prospective Study to Collect Real-life Data On the Retention, Quality of Life, Effectiveness and Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial spondyloarthriTis (PROMPT)
Acronym: PROMPT
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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