RecruitingNCT05952440

Dissecting the Cellular and Molecular Atlas of Rheumatoid Arthritis in Sustained Remission to Identify Pathways Maintaining Remission and Triggering Flares


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

130 participants

Start Date

Jul 11, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The FLARE-RA study will have the following research objectives: A) To establish the cellular and molecular atlas of remission RA achieved with different therapeutics aimed to identify (i) cell clusters/pathways driving disease flare or maintaining remission and (ii) provide an evidence base for developing ML tools for predicting flares. B) To test the performance of a ML-derived algorithm on longitudinal remission RA cohort in a biopsy-driven study. C) To dissect the cellular and molecular mechanisms of remission maintenance and joint flares.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is examining the cells and molecules in the joints of rheumatoid arthritis (RA) patients who are in sustained remission (no active disease) to understand what keeps the disease quiet — and what might trigger a flare. This knowledge could help develop strategies to maintain remission and prevent relapses. **You may be eligible if...** - You have been diagnosed with rheumatoid arthritis (based on 2010 EULAR/ACR criteria) - You have been in sustained remission for at least 6 months (DAS28-CRP score below 2.6) - You have been on stable medications (conventional or biologic DMARDs) for at least 12 months - You have not been on steroids for at least 6 months - Ultrasound of your joints shows no signs of active inflammation on three separate assessments **You may NOT be eligible if...** - Your disease activity score (DAS28-CRP) is 2.6 or higher - Ultrasound shows active blood flow signals in your joints - You have another chronic inflammatory disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERTapering and/or discontinuation of treatment based on AI-guidance

After synovial tissue biopsy, pharmacological treatment (cDMARDs or bDMARDs) are tapered first and then bDMARDs and/or cDMARDs are discontinued based on AI-guidance

OTHERNo tapering and/or discontinuation of treatment based on AI-guidance

Ongoing therapeutic are not changed (tapered or discontinued) after synovial biopsy performance based on AI-guidance

OTHERTapering and/or discontinuation of treatment based on standard of care

After synovial tissue biopsy, pharmacological treatment (cDMARDs or bDMARDs) are tapered first and then bDMARDs and/or cDMARDs are discontinued based on standard of care

OTHERNo tapering and/or discontinuation of treatment based on standard of care

Ongoing therapeutic are not changed (tapered or discontinued) after synovial biopsy performance based on standard of care


Locations(4)

Division of Rheumatology

Rome, Italy

Hospital Clinic and Fundació Clinic per la Recerca Biomèdica

Barcelona, Spain

Research into Inflammatory Arthritis Centre Versus Arthritis (RACE)

Glasgow, United Kingdom

Newcastle University

Newcastle upon Tyne, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05952440


Related Trials