Status:
RECRUITING
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
Lead Sponsor:
AbbVie
Conditions:
Juvenile Psoriatic Arthritis
Eligibility:
All Genders
5-18 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 3 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.
Exclusion
- 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 treatments in the anti-TNF or IL-23 inhibitor classes.
Key Trial Info
Start Date :
July 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06100744
Start Date
July 8 2024
End Date
October 1 2028
Last Update
December 29 2025
Active Locations (31)
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1
Arkansas Children's Hospital /ID# 258776
Little Rock, Arkansas, United States, 72202
2
Childrens National Medical Center /ID# 259284
Washington D.C., District of Columbia, United States, 20010-2916
3
Joe Dimaggio Children's Hospital Hollywood /ID# 260634
Hollywood, Florida, United States, 33021
4
Indiana University Health Riley Hospital for Children /ID# 259067
Indianapolis, Indiana, United States, 46202