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

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 21 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 21
Healthy Volunteers: No
View:

• Males or females age 8 to 21 years

• 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

• Currently taking one of the following TNFi therapies (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab) at standard doses and dosing intervals

• Have reached a clinically inactive disease state for a minimum of six months, as determined by treating physician

• English speaking or Spanish speaking

• Interested and willing to de-escalate TNFi therapy

Locations
United States
Alabama
University of Alabama at Birmingham
Recruiting
Birmingham
California
Children's Hospital Los Angeles
Recruiting
Los Angeles
Stanford University
Recruiting
Palo Alto
Colorado
Children's Hospital of Colorado
Recruiting
Aurora
Washington, D.c.
Children's National Health System
Recruiting
Washington
Delaware
Nemours Children's Hospital
Recruiting
Wilmington
Florida
Nemours Children's Health
Recruiting
Orlando
Georgia
Children's Healthcare of Atlanta
Recruiting
Atlanta
Iowa
University of Iowa Stead Family Children's Hospital
Recruiting
Iowa City
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Recruiting
Chicago
Minnesota
University of Minnesota Masonic Children's Hospital
Recruiting
Minneapolis
Missouri
St. Louis Children's Hospital
Recruiting
Saint Louis
Ohio
Akron Children's Hospital
Recruiting
Akron
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati
Nationwide Children's Hospital
Recruiting
Columbus
Oregon
Randall Children's Hospital at Legacy Emanuel
Recruiting
Portland
Pennsylvania
The Children's Hospital of Philadelphia
Recruiting
Philadelphia
UPMC Children's Hospital of Pittsburgh
Recruiting
Pittsburgh
Texas
Texas Children's Hospital - Baylor College of Medicine
Recruiting
Houston
Utah
Primary Children's Hospital
Recruiting
Salt Lake City
Washington
Seattle Children's Hospital
Recruiting
Seattle
Contact Information
Primary
Cora Sears, MPH
searsc@chop.edu
(267) 425-2122
Backup
Tim Brandon, MPH
brandont@chop.edu
(267) 425-1423
Time Frame
Start Date: November 11, 2021
Estimated Completion Date: March 1, 2025
Participants
Target number of participants: 198
Treatments
Active Comparator: TNFi Standard Therapy
Continue fixed standard treatment (i.e., no change from current therapy)
Experimental: TNFi fixed longer dosing intervals
Fixed longer dosing intervals of TNFi (i.e., increased time between doses)
Experimental: TNFi Therapy Withdrawal
Stop TNFi treatment
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Philadelphia
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov

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