Status:
ACTIVE_NOT_RECRUITING
Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Juvenile Spondyloarthritis
Eligibility:
All Genders
8-21 years
Phase:
NA
Brief Summary
This randomized pragmatic trial will generate knowledge about strategies used to de-escalate tumor necrosis factor inhibitor (TNFi) therapy in patients with juvenile spondyloarthritis with sustained i...
Detailed Description
This project is a prospective, 12-month pragmatic randomized trial embedded within routine clinical care. Children with spondyloarthritis who have maintained inactive disease on a clinically prescribe...
Eligibility Criteria
Inclusion
- Males or females age 8 to 21 years
- Juvenile SpA diagnosis (symptom onset before their 16th birthday):
- Pediatric Rheumatology International Trials Organization (PRINTO) revision of the The International League of Associations for Rheumatology (ILAR) criteria enthesitis/spondylitis-related Juvenile idiopathic arthritis (JIA)
- Peripheral arthritis and enthesitis, or
- Arthritis or enthesitis, plus ≥ 3 months of inflammatory back pain and sacroiliitis on imaging, or
- Arthritis or enthesitis plus 2 of the following: (1) sacroiliac joint tenderness; (2) inflammatory back pain; (3) presence of Human leukocyte antigen (HLA-B27) ; (4) acute (symptomatic) anterior uveitis; and (5) history of a SpA in a first-degree relative
- Currently taking one of the following TNFi therapies (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab) at standard doses and dosing intervals
- Have reached a clinically inactive disease state for a minimum of six months, as determined by treating physician
- English speaking or Spanish speaking
- Interested and willing to de-escalate TNFi therapy
Exclusion
- 1\) History of inflammatory bowel disease, history of uveitis that was not adequately controlled with localized ophthalmic treatment or psoriasis that pre-dates the start of TNFi therapy or psoriasis that started after TNFi therapy and has required more than topical therapy for control
Key Trial Info
Start Date :
November 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT04891640
Start Date
November 11 2021
End Date
July 1 2026
Last Update
August 5 2025
Active Locations (31)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Phoenix Children's
Phoenix, Arizona, United States, 85006
3
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
4
Stanford University
Palo Alto, California, United States, 94304