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TNFi Therapy Strategies for Juvenile Spondyloarthritis (BACK-OFF JSpA Trial)
BACK-OFF JSpA Trial Summary
This trial will compare strategies for reducing TNFi therapy in kids with juvenile spondyloarthritis who have sustained inactive disease. It will look at the risk and timing of flare and patients' experiences across three different arms.
BACK-OFF JSpA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBACK-OFF JSpA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BACK-OFF JSpA Trial Design
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Who is running the clinical trial?
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- I am between 8 and 21 years old.My arthritis symptoms started before I was 16.My psoriasis started before my TNF inhibitor treatment.I have arthritis or enthesitis and at least two other related symptoms.My disease has been inactive for at least six months, as confirmed by my doctor.I have a history of inflammatory bowel disease.I am currently on a standard dose of a TNF inhibitor medication.My eye inflammation wasn't controlled with local treatments.I speak English or Spanish.I have joint pain and inflammation where tendons attach to bones.My psoriasis began after TNFi therapy and needs more than creams to manage.You have a type of arthritis called enthesitis/spondylitis-related Juvenile idiopathic arthritis (JIA) based on specific criteria set by medical organizations.I have arthritis or enthesitis, back pain for 3+ months, and sacroiliitis confirmed by imaging.I am open to reducing my TNFi medication under supervision.
- Group 1: TNFi fixed longer dosing intervals
- Group 2: TNFi Standard Therapy
- Group 3: TNFi Therapy Withdrawal
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many healthcare facilities have enrolled in this research study?
"The University of Alabama at Birmingham in Birmingham, Alabama, UPMC Children's Hospital of Pittsburgh in Pennsylvania and Children's Hospital Los Angeles in Utah are three primary sites for this study. An additional 22 medical centres have also been identified to help with recruitment efforts."
What is the cumulative count of participants of this trial?
"Affirmative. Per the data published on clinicaltrials.gov, this scientific research is actively looking for volunteers to participate in its study which was first listed on November 11th 2021 and last updated on November 3rd 2022. 198 patients are needed at 22 distinct medical centres across the country."
Are there any current openings in this clinical investigation?
"The clinical trial portal reveals that participant recruitment is ongoing for this medical study. It was originally posted on November 11th 2021 and last edited on November 3rd 2022."
Are geriatric patients being welcomed into this medical research project?
"According to the study's prerequisites, aspiring participants must lie between 8 and 21 years old. Furthermore, there are specialised trials for minors aged 18 or younger as well senior citizens over 65."
Are there any prerequisites for enrolling in this medical experiment?
"This clinical trial seeks 198 participants aged 8 to 21 years old with spondylitis. Eligibility includes meeting the PRINTO/ILAR criteria for JIA, peripheral arthritis and enthesitis or joint pain plus 2 additional factors such as sacroiliac tenderness, HLA-B27 status etc., taking one of several TNFi therapies at standard dosages, being able to understand English or Spanish and having been in a clinically inactive state for 6 months prior."
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