ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-11-11
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04891640

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.

Ages Eligible for Study:8 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Males or females age 8 to 21 years
  2. 2. Juvenile SpA diagnosis (symptom onset before their 16th birthday):
  3. * Peripheral arthritis and enthesitis, or
  4. * Arthritis or enthesitis, plus ≥ 3 months of inflammatory back pain and sacroiliitis on imaging, or
  5. * 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
  6. 3. Currently taking one of the following TNFi therapies (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab) at standard doses and dosing intervals
  7. 4. Have reached a clinically inactive disease state for a minimum of six months, as determined by treating physician
  8. 5. English speaking or Spanish speaking
  9. 6. Interested and willing to de-escalate TNFi therapy
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Phoenix Children's
Phoenix, Arizona, 85006
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Stanford University
Palo Alto, California, 94304
United States
Children's Hospital of Colorado
Aurora, Colorado, 80045
United States
Nemours Children's Hospital
Wilmington, Delaware, 19803
United States
Children's National Health System
Washington, District of Columbia, 20010
United States
Nemours Children's Health
Orlando, Florida, 32827
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
United States
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa, 52242
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55455
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
St. Louis Children's Hospital
Saint Louis, Missouri, 63110
United States
Hospital for Special Surgery
New York, New York, 10021
United States
Cohen Children's Medical Center
Queens, New York, 11040
United States
Akron Children's Hospital
Akron, Ohio, 44302
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Randall Children's Hospital at Legacy Emanuel
Portland, Oregon, 97227
United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
Texas Children's Hospital - Baylor College of Medicine
Houston, Texas, 77030
United States
Primary Children's Hospital
Salt Lake City, Utah, 84113
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-11
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2021-11-11
Study Completion Date2026-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Juvenile Spondyloarthritis