Clinical Research Directory
Browse clinical research sites, groups, and studies.
Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis
Sponsor: Children's Hospital of Philadelphia
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 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.
Official title: Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)
Key Details
Gender
All
Age Range
8 Years - 21 Years
Study Type
INTERVENTIONAL
Enrollment
164
Start Date
2021-11-11
Completion Date
2026-07-01
Last Updated
2025-08-05
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (31)
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