NCT05952440

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-07-11
• Primary completion: 2026-05-10
• Completion: 2026-05-10
• First posted: 2023-07-19
• Last updated: 2023-07-21

Locations

4 sites across 3 countries: Italy, Spain, United Kingdom