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Biologic Agent

TNFi Therapy Strategies for Juvenile Spondyloarthritis (BACK-OFF JSpA Trial)

N/A

Recruiting

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males or females age 8 to 21 years

Juvenile SpA diagnosis (symptom onset before their 16th birthday):

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

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.

Who is the study for?

This trial is for kids and young adults aged 8 to 21 with juvenile spondyloarthritis, who have been symptom-free for at least six months while on standard TNFi therapy. They must meet specific criteria including arthritis or enthesitis, and not have certain conditions like inflammatory bowel disease or psoriasis requiring more than topical treatment.Check my eligibility

What is being tested?

The study tests three approaches in patients with inactive juvenile spondyloarthritis: continuing standard TNFi therapy, stopping TNFi treatment altogether, or extending the time between doses of TNFi. It aims to see which strategy best balances flare frequency with quality of life.See study design

What are the potential side effects?

TNFi therapies can cause immune system weakening leading to infections, injection site reactions, potential allergic responses, and sometimes may affect liver function. The exact side effects will depend on the specific type of TNFi used.

BACK-OFF JSpA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 8 and 21 years old.

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My arthritis symptoms started before I was 16.

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I am currently on a standard dose of a TNF inhibitor medication.

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I speak English or Spanish.

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I have arthritis or enthesitis, back pain for 3+ months, and sacroiliitis confirmed by imaging.

BACK-OFF JSpA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Juvenile Spondyloarthritis (JSpA) flare

Secondary outcome measures

Pain interference (as measured by the PROMIS short form)

BACK-OFF JSpA Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: TNFi fixed longer dosing intervalsExperimental Treatment1 Intervention

Fixed longer dosing intervals of TNFi (i.e., increased time between doses)

Group II: TNFi Therapy WithdrawalExperimental Treatment1 Intervention

Stop TNFi treatment

Group III: TNFi Standard TherapyActive Control1 Intervention

Continue fixed standard treatment (i.e., no change from current therapy)

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,997,260 Total Patients Enrolled

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,580,861 Total Patients Enrolled

Media Library

Standard TNFi Therapy (Biologic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04891640 — N/A

Spondyloarthritis Research Study Groups: TNFi fixed longer dosing intervals, TNFi Standard Therapy, TNFi Therapy Withdrawal

Spondyloarthritis Clinical Trial 2023: Standard TNFi Therapy Highlights & Side Effects. Trial Name: NCT04891640 — N/A

Standard TNFi Therapy (Biologic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04891640 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04891640.

All > Ankylosing Spondylitis