RECRUITING

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

Description

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 29 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.

Conditions

Juvenile Spondyloarthritis
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Related Conditions:

Juvenile Spondyloarthritis

Study Overview

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Study Details

Study overview

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 29 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.

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

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

Condition
Juvenile Spondyloarthritis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Phoenix

Phoenix Children's, Phoenix, Arizona, United States, 85006

Los Angeles

Children's Hospital Los Angeles, Los Angeles, California, United States, 90027

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

Aurora

Children's Hospital of Colorado, Aurora, Colorado, United States, 80045

Wilmington

Nemours Children's Hospital, Wilmington, Delaware, United States, 19803

Washington

Children's National Health System, Washington, District of Columbia, United States, 20010

Orlando

Nemours Children's Health, Orlando, Florida, United States, 32827

Atlanta

Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30329

Chicago

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, 60611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Males or females age 8 to 21 years
  • 2. Juvenile SpA diagnosis (symptom onset before their 16th birthday):
  • * 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

Ages Eligible for Study

8 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital of Philadelphia,

Study Record Dates

2027-07-01