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RECRUITING
NCT05952440

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

130

Start Date

2023-07-11

Completion Date

2026-05-10

Last Updated

2023-07-21

Healthy Volunteers

Not specified

Interventions

OTHER

Tapering 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

OTHER

No 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

OTHER

Tapering 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

OTHER

No 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