Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis
NCT ID: NCT04891640
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
164 participants
INTERVENTIONAL
2021-11-11
2026-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TNFi Standard Therapy
Continue fixed standard treatment (i.e., no change from current therapy)
Standard TNFi Therapy
Participants randomly assigned to this arm will continue taking their TNFi medication as currently prescribed.
TNFi fixed longer dosing intervals
Fixed longer dosing intervals of TNFi (i.e., increased time between doses)
TNFi fixed longer dosing intervals
Participants randomly assigned to this arm will increase the time between TNFi medication doses.
* Adalimumab- from every 2 to 3 weeks
* Certolizumab- from every 2 to 4 weeks
* Etanercept- from every 1 to 2 weeks
* Golimumab- from every 4 to 6 weeks
* Infliximab- from baseline to baseline + 2 weeks
TNFi Therapy Withdrawal
Stop TNFi treatment
Stop TNFi treatment
Participants randomly assigned to this arm will stop TNFi medication.
Interventions
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Standard TNFi Therapy
Participants randomly assigned to this arm will continue taking their TNFi medication as currently prescribed.
TNFi fixed longer dosing intervals
Participants randomly assigned to this arm will increase the time between TNFi medication doses.
* Adalimumab- from every 2 to 3 weeks
* Certolizumab- from every 2 to 4 weeks
* Etanercept- from every 1 to 2 weeks
* Golimumab- from every 4 to 6 weeks
* Infliximab- from baseline to baseline + 2 weeks
Stop TNFi treatment
Participants randomly assigned to this arm will stop TNFi medication.
Eligibility Criteria
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Inclusion Criteria
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
8 Years
21 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Locations
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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
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Texas Children's Hospital - Baylor College of Medicine
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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References
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Weiss PF, Sears CE, Brandon TG, Forrest CB, Neu E, Kohlheim M, Leal J, Xiao R, Lovell D. Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA): study protocol for a randomized pragmatic trial. Trials. 2023 Feb 8;24(1):100. doi: 10.1186/s13063-022-07038-6.
Other Identifiers
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: GRT-00001036
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
21-018442
Identifier Type: -
Identifier Source: org_study_id
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