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Could less be more? testing whether kids can ease off arthritis meds

NCT ID NCT04891640

Disease control Sponsor: Children's Hospital of Philadelphia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial looks at whether children with juvenile spondyloarthritis who have stable, inactive disease can safely reduce or stop their TNFi medication without causing a flare. Participants are randomly assigned to continue their usual TNFi dose, take it less frequently, or stop it entirely. The study tracks how often disease flares occur and how children feel about their treatment, aiming to find the best strategy for managing long-term care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tumor necrosis factor inhibitor (TNFi) medications, including adalimumab, certolizumab, etanercept, golimumab, and infliximab
What this could lead to
If successful, this could help doctors find the safest way to reduce or stop TNFi medications in children with stable juvenile spondyloarthritis, potentially lowering drug exposure and side effects while maintaining disease control.
What could go wrong
This is a pragmatic trial in routine care, so results may vary across clinics. Stopping or spacing out TNFi could increase the risk of disease flares, and the study's findings may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

164 people

The number who actually took part.

Started

Nov 2021

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males or females age 8 to 21 years 2. 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. 3. Currently taking one of the following TNFi therapies (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab, or TNFi biosimilar) at standard doses 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. Subject's treating physician recommended that he/she is a good candidate to participate in the study, which may include a modified therapy 7. 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

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Conditions

The condition(s) this trial relates to.

juvenile spondyloarthropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Juvenile spondyloarthritis

Contacts and locations

Locations

  • Akron Children's Hospital

    Akron, Ohio, 44302, United States

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital of Colorado

    Aurora, Colorado, 80045, United States

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • Children's National Health System

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Cohen Children's Medical Center

    Queens, New York, 11040, United States

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Nemours Children's Health

    Orlando, Florida, 32827, United States

  • Nemours Children's Hospital

    Wilmington, Delaware, 19803, United States

  • Phoenix Children's

    Phoenix, Arizona, 85006, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • Randall Children's Hospital at Legacy Emanuel

    Portland, Oregon, 97227, United States

  • Riley Hospital for Children at IU Health

    Indianapolis, Indiana, 46202, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • Texas Children's Hospital - Baylor College of Medicine

    Houston, Texas, 77030, United States

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1E8, Canada

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Iowa Stead Family Children's Hospital

    Iowa City, Iowa, 52242, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota Masonic Children's Hospital

    Minneapolis, Minnesota, 55455, United States

  • Vanderbilt Children's Hospital

    Nashville, Tennessee, 37232, United States