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NCT04891640 | RECRUITING | Juvenile Spondyloarthritis

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

Children's Hospital of Philadelphia

Brief 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.

Condition or disease

Juvenile Spondyloarthritis

Intervention/treatment

Standard TNFi Therapy

TNFi fixed longer dosing intervals

Stop TNFi treatment

Phase

NA

Detailed Description:

This project is a prospective, 12-month pragmatic randomized trial embedded within routine clinical care. Children with spondyloarthritis who have maintained inactive disease on a clinically prescribed standard dosing of a TNFi for 6 months or longer will be eligible for enrollment. Children will be randomized to one of the following alternative approaches: continued fixed standard dosing (arm 1), fixed longer dosing intervals of TNFi (arm 2), or stopping TNFi (arm 3). The recommended visit frequency is every 3 months through the study endpoint at 12 months. After subjects have followed their treatment assignment for 12 months, those who have not flared may modify their treatment regimen as per shared decision making between themselves and the treating physician. All participants will be monitored for 24 additional months for long-term outcomes after the intervention period.

Study Type : INTERVENTIONAL
Estimated Enrollment : 198 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)
Actual Study Start Date : 2021-11-11
Estimated Primary Completion Date : 2026-07-01
Estimated Study Completion Date : 2027-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 8 Years to 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Males or females age 8 to 21 years
  • 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
    • 1) History of inflammatory bowel disease, history of uveitis that was not adequately controlled with localized ophthalmic treatment or psoriasis that pre-dates the start of TNFi therapy or psoriasis that started after TNFi therapy and has required more than topical therapy for control
Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis

Location Details

NCT04891640

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

RECRUITING

United States, Arizona

Phoenix Children's

Phoenix, arizona, United States, 85006

RECRUITING

United States, California

Children's Hospital Los Angeles

Los Angeles, California, United States, 90027

RECRUITING

United States, California

Stanford University

Palo Alto, California, United States, 94304

RECRUITING

United States, Colorado

Children's Hospital of Colorado

Aurora, Colorado, United States, 80045

RECRUITING

United States, Delaware

Nemours Children's Hospital

Wilmington, Delaware, United States, 19803

RECRUITING

United States, District of Columbia

Children's National Health System

Washington, District of Columbia, United States, 20010

RECRUITING

United States, Florida

Nemours Children's Health

Orlando, Florida, United States, 32827

RECRUITING

United States, Georgia

Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30329

RECRUITING

United States, Illinois

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611

RECRUITING

United States, Indiana

Riley Hospital for Children at IU Health

Indianapolis, Indiana, United States, 46202

RECRUITING

United States, Iowa

University of Iowa Stead Family Children's Hospital

Iowa City, Iowa, United States, 52242

RECRUITING

United States, Massachusetts

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

RECRUITING

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

RECRUITING

United States, Minnesota

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, United States, 55455

RECRUITING

United States, Missouri

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

RECRUITING

United States, Missouri

St. Louis Children's Hospital

St. Louis, Missouri, United States, 63110

RECRUITING

United States, New York

Hospital for Special Surgery

New York, New York, United States, 10021

RECRUITING

United States, New York

Cohen Children's Medical Center

Queens, New York, United States, 11040

RECRUITING

United States, Ohio

Akron Children's Hospital

Akron, Ohio, United States, 44302

RECRUITING

United States, Ohio

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

RECRUITING

United States, Ohio

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

RECRUITING

United States, Oregon

Randall Children's Hospital at Legacy Emanuel

Portland, Oregon, United States, 97227

RECRUITING

United States, Pennsylvania

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Pennsylvania

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15224

RECRUITING

United States, Tennessee

Vanderbilt Children's Hospital

Nashville, Tennessee, United States, 37232

RECRUITING

United States, Texas

UT Southwestern Medical Center

dallas, Texas, United States, 75390

RECRUITING

United States, Texas

Texas Children's Hospital - Baylor College of Medicine

Houston, Texas, United States, 77030

RECRUITING

United States, Utah

Primary Children's Hospital

Salt Lake City, Utah, United States, 84113

RECRUITING

United States, Washington

Seattle Children's Hospital

Seattle, Washington, United States, 98105

RECRUITING

Canada, Ontario

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1E8