Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis

Completed · Phase 4

Conditions studied: Juvenile Spondyloarthritis

In brief

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 inactive disease and are treated at one of the 31 participating pediatric healthcare systems. This open label study will be conducted in the setting of routine clinical care and will compare the risk and timing of flare (Aim 1) and patients' lived experiences (Aim 2) across three arms.

Key facts

Study ID

NCT04891640

Run by

Children's Hospital of Philadelphia

People needed

164

Starts

2021-11-11

Expected to finish

2026-06-01

Last updated by the study team

2026-08-05

Who can join

Age: 8 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females age 8 to 21 years
• Juvenile SpA diagnosis:
• Symptom onset before their 16th birthday:
• o International League of Associations for Rheumatology (ILAR) criteria for juvenile idiopathic arthritis enthesitis-related arthritis subtype
• OR;
• Symptom onset before their 18th birthday:
• o Pediatric Rheumatology International Trials Organization (PRINTO) revision of the ILAR criteria enthesitis spondylitis-related 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 HLA-B27 antigen; (4) acute (symptomatic) anterior uveitis; and (5) history of a SpA in a first-degree relative.
• If peripheral arthritis is present, it should persist for at least 6 weeks.
• Currently taking one of the following TNFi therapies (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab, or TNFi biosimilar) at standard doses
• Have reached a clinically inactive disease state for a minimum of six months, as determined by treating physician
• English speaking or Spanish speaking
• Subject's treating physician recommended that he/she is a good candidate to participate in the study, which may include a modified therapy
• Interested and willing to de-escalate TNFi therapy

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Phoenix Children's — Phoenix, Arizona, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• Children's Hospital of Colorado — Aurora, Colorado, United States
• Nemours Children's Hospital — Wilmington, Delaware, United States
• Children's National Health System — Washington D.C., District of Columbia, United States
• Nemours Children's Health — Orlando, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Riley Hospital for Children at IU Health — Indianapolis, Indiana, United States
• University of Iowa Stead Family Children's Hospital — Iowa City, Iowa, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota Masonic Children's Hospital — Minneapolis, Minnesota, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Hospital for Special Surgery — New York, New York, United States
• Cohen Children's Medical Center — Queens, New York, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Randall Children's Hospital at Legacy Emanuel — Portland, Oregon, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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