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De-escalating TNFi therapy in children with juvenile spondyloarthritis

Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)

Not applicable Interventional Children's Hospital of Philadelphia · NCT04891640

This study is testing different ways to reduce or stop TNFi therapy in children with juvenile spondyloarthritis who are doing well to see how it affects their health over the next two years.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment198 (estimated)
Ages8 Years to 21 Years
SexAll
SponsorChildren's Hospital of Philadelphia Academic / other
Drugs / interventionsAdalimumab, Certolizumab, Golimumab, Infliximab
Locations31 sites (Birmingham, Alabama and 30 other locations)
Trial IDNCT04891640 on ClinicalTrials.gov

What this trial studies

This pragmatic trial investigates strategies for reducing tumor necrosis factor inhibitor (TNFi) therapy in children with juvenile spondyloarthritis who have maintained inactive disease. Participants aged 8 to 21 will be randomized into three groups: continuing standard TNFi dosing, extending dosing intervals, or stopping TNFi altogether. The study will monitor flare frequency and patient experiences over a 12-month period, with follow-up for long-term outcomes for an additional 24 months. The trial is embedded within routine clinical care across 29 pediatric healthcare systems.

Who should consider this trial

Good fit: Ideal candidates are children aged 8 to 21 with a diagnosis of juvenile spondyloarthritis who have been on TNFi therapy and have achieved a clinically inactive disease state for at least six months.

Not a fit: Patients who have not achieved inactive disease or are not currently on TNFi therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help optimize TNFi therapy in children, potentially reducing medication burden while maintaining disease control.

How similar studies have performed: Other studies have explored TNFi de-escalation strategies, indicating potential for success, but this specific approach is novel in the pediatric population.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Males or females age 8 to 21 years
2. 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
3. Currently taking one of the following TNFi therapies (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab) at standard doses and dosing intervals
4. Have reached a clinically inactive disease state for a minimum of six months, as determined by treating physician
5. English speaking or Spanish speaking
6. Interested and willing to de-escalate TNFi therapy

Exclusion Criteria:

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

Where this trial is running

Birmingham, Alabama and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Juvenile Spondyloarthritis
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.