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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06100744
Registration number
NCT06100744
Ethics application status
Date submitted
20/10/2023
Date registered
25/10/2023
Titles & IDs
Public title
A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab
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Scientific title
Open-label, Randomized, Assessor-blinded, Efficacy, Safety, Tolerability, and Pharmacokinetics Study of Subcutaneous Risankizumab With an Adalimumab Reference Arm in Children With Active Juvenile Psoriatic Arthritis
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Secondary ID [1]
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2023-506026-36-00
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Secondary ID [2]
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M23-732
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Juvenile Psoriatic Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Adalimumab
Treatment: Drugs - Risankizumab
Experimental: Risankizumab - Participants will receive risankizumab for 24 weeks, in Period 1. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. There will be a 140 day safety follow up after the treatment period.
Experimental: Adalimumab - Participants will receive adalimumab for 24 weeks, in Period 1. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. There will be a 70 day safety follow up after the treatment period.
Treatment: Drugs: Adalimumab
SC Injection
Treatment: Drugs: Risankizumab
Subcutaneous (SC) Injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30)
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Assessment method [1]
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The JIA-ACR 30 response is defined as a \>= 30% improvement of at least 3 or more of the 6 juvenile idiopathic arthritis core response variables (JIA-CRVs) without \>30% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: physician global assessment of disease activity (PhGA), global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion high sensitivity C-reactive protein (hsCRP), and functional ability assessed by Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI).
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Timepoint [1]
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Up to 24 Weeks
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Secondary outcome [1]
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Percentage of Participants who Achieve >= 50% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 50)
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Assessment method [1]
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The JIA-ACR 50 response is defined as a \>= 50% improvement of at least 3 or more of the 6 JIA-CRVs without \>50% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: PhGA, parent/patient global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion hsCRP, and functional ability assessed using the disability index of the CHAQ-DI.
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Timepoint [1]
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Up to 24 Weeks
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Secondary outcome [2]
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Percentage of Participants who Achieve >= 70% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 70)
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Assessment method [2]
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The JIA-ACR 70 response is defined as a \>= 70% improvement of at least 3 or more of the 6 JIA-CRVs without \>70% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: PhGA, parent/patient global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion hsCRP, and functional ability assessed using the disability index of the CHAQ-DI.
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Timepoint [2]
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Up to 24 Weeks
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Secondary outcome [3]
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Percentage of Participants who Achieve >= 90% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 90)
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Assessment method [3]
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The JIA-ACR 90 response is defined as a \>= 90% improvement of at least 3 or more of the 6 JIA-CRVs without \>90% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: PhGA, parent/patient global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion hsCRP, and functional ability assessed using the disability index of the CHAQ-DI.
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Timepoint [3]
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Up to 24 Weeks
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Secondary outcome [4]
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Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-10
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Assessment method [4]
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JADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both), and high sensitivity C-reactive protein (hsCRP). JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints.
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Timepoint [4]
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Up to Week 24
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Secondary outcome [5]
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Change from Baseline in JADAS-27
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Assessment method [5]
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JADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both), and hsCRP. JADAS-27 includes a count of the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), and proximal interphalangeal joints, hips, knees, and ankles.
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Timepoint [5]
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Up to Week 24
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Secondary outcome [6]
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Percentage of Participants with Achievement of Minimal Disease Activity (MDA)
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Assessment method [6]
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MDA is defined as JADAS-10 of \<= 6. JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints.
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Timepoint [6]
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Week 24
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Secondary outcome [7]
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Percentage of Participants with Inactive Disease
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Assessment method [7]
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Inactive disease is defined as JADAS-10 of \<= 2.7. JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints.
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Timepoint [7]
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Week 24
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Secondary outcome [8]
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Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS)-10
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Assessment method [8]
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cJADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, and number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both). JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints.
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Timepoint [8]
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Up to Week 24
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Secondary outcome [9]
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Change from Baseline in cJADAS-27
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Assessment method [9]
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cJADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, and number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both). JADAS-27 includes a count of the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), and proximal interphalangeal joints, hips, knees, and ankles.
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Timepoint [9]
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Up to Week 24
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Secondary outcome [10]
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Change from Baseline in the Pain-Visual Analogue Scale (VAS)
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Assessment method [10]
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Participants assessed their pain using a Patient's Global Assessment Pain visual analogue scale (VAS). The range is 0 to 100 with no pain being indicated by 0 and severe pain by 100.
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Timepoint [10]
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Week 24
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Secondary outcome [11]
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Percentage of Participants with Psoriasis (PsO) who Achieve Psoriasis Area Severity Index (PASI) 75 in Participants with at least 3% Body Surface Area (BSA) at Baseline
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Assessment method [11]
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The PASI is a measure of psoriasis severity. Four anatomic sites - head, upper extremities, trunk, and lower extremities - are assessed for erythema, induration and desquamation using a 5-point scale, with a lower score indicating more mild disease.
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Timepoint [11]
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Up to Week 24
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Secondary outcome [12]
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Percentage of Participants with PsO who Achieve PASI 90 in Participants with at least 3% BSA at Baseline
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Assessment method [12]
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The PASI is a measure of psoriasis severity. Four anatomic sites - head, upper extremities, trunk, and lower extremities - are assessed for erythema, induration and desquamation using a 5-point scale, with a lower score indicating more mild disease.
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Timepoint [12]
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Up to Week 24
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Secondary outcome [13]
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Percentage of Participants with PsO who Achieve Static Physician Global Assessment of Disease Activity (sPGA) of PsO of 'Clear' (0) or Almost Clear (1) in Participants with at least 3% BSA at Baseline
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Assessment method [13]
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The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions, with a lower score indicating less body coverage.
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Timepoint [13]
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Up to Week 24
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Secondary outcome [14]
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Percentage of Participants with PsO who Achieve change from Baseline in Children's Dermatology Life Quality Index (CDLQI) in Participants with at least 3% BSA at Baseline
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Assessment method [14]
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The CDLQI is a 10-item questionnaire used to assess the impact of dermatologic disease symptoms and treatment on quality-of-life (QOL), with a higher score indicating greater impairment of QOL. The CDLQI has been validated for use in participants 4 to 16 years old.
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Timepoint [14]
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Up to Week 24
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Eligibility
Key inclusion criteria
* Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 6 months prior to screening.
* Active Disease in >= 3 joints at screening and at Baseline (swelling not due to deformity, or limitation of motion with pain, tenderness, or both) are eligible for inclusion in the study.
* Have had an inadequate response (lack of efficacy after minimum 2-month duration of therapy at maximally tolerated dose), or intolerance to previous or current treatment with at least 1 of the following conventional synthetic disease-modifying antirheumatic drug (csDMARDs): methotrexate (MTX), sulfasalazine, leflunomide, or hydroxychloroquine.
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Minimum age
5
Years
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Maximum age
18
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Have any other autoimmune disease, rheumatic disease (including systemic Juvenile idiopathic arthritis [JIA], rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA, persistent oligoarticular JIA, enthesitis-related arthritis, and undifferentiated JIA), or overlap syndrome.
* Prior inadequate response to drugs in the anti-TNF, IL-23 inhibitor, and IL-12/23 inhibitor classes.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/07/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
7/10/2028
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Medical Centre /ID# 260255 - Clayton
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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United States of America
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State/province [2]
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Florida
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United States of America
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State/province [3]
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Indiana
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Country [4]
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United States of America
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State/province [4]
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Minnesota
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Country [5]
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United States of America
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State/province [5]
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New York
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Country [6]
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United States of America
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State/province [6]
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North Carolina
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Country [7]
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United States of America
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State/province [7]
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Ohio
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Country [8]
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United States of America
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State/province [8]
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Texas
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Country [9]
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Canada
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State/province [9]
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Alberta
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Country [10]
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France
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State/province [10]
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Gironde
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Country [11]
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France
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State/province [11]
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Paris
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Country [12]
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Germany
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State/province [12]
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Saarland
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Country [13]
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Germany
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State/province [13]
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Hamburg
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Country [14]
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Italy
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State/province [14]
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Firenze
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Country [15]
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Poland
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State/province [15]
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Lodzkie
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Country [16]
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Poland
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State/province [16]
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Malopolskie
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Country [17]
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Spain
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State/province [17]
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Barcelona
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Country [18]
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Spain
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State/province [18]
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Valencia
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Country [19]
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United Kingdom
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State/province [19]
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Liverpool
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient's 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms. Risankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide. Participants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study. Participants who receive adalimumab are followed for safety for 70 days after the last study treatment. Participants who receive risankizumab are followed for 140 days after the last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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Trial website
https://clinicaltrials.gov/study/NCT06100744
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
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Country
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Phone
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844-663-3742
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06100744