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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS130 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

130

Conditions

Rheumatoid Arthritis

Interventions

Tapering and/or discontinuation of treatment based on AI-guidanceOTHER

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

Tapering and/or discontinuation of treatment based on standard of careOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Rheumatoid Arthritis classified based on the 2010 EULAR/ACR Classification Criteria * Stable treatment with cDMARDs and/or bDMARDs (≥12 months) * Stable remission status (at least DAS28-CRP\<2.6) (≥6 months) * No concomitant steroid treatment (≥6 months) * Absence of Power-Doppler signal at ultrasound assessment (wrist, MCP, PIP, Knee, ankle and II-V MTP bilaterally) in 3 evaluations 3 months apart. Exclusion Criteria: * DAS28-CRP≥2.6 * Presence of Power-Doppler signal ≥1 at ultrasound assessment (wrist, MCP, PIP, Knee, ankle and II-V MTP bilaterally) * Other chronic inflammatory disease

Locations (4)

Division of Rheumatology

Rome, Italy

RECRUITING

Hospital Clinic and Fundació Clinic per la Recerca Biomèdica

Barcelona, Spain

NOT_YET_RECRUITING

Research into Inflammatory Arthritis Centre Versus Arthritis (RACE)

Glasgow, United Kingdom

ACTIVE_NOT_RECRUITING

Newcastle University

Newcastle upon Tyne, United Kingdom

ACTIVE_NOT_RECRUITING

Outcomes

Primary Outcomes

Establishment of cellular and molecular atlas of remission RA

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.

Time frame: months 1-12

Secondary Outcomes

To test the performance of a ML-derived algorithm on longitudinal remission RA cohort in a biopsy-driven study.

Time frame: months 13-36

To dissect the cellular and molecular mechanisms of remission maintenance and joint flares

To dissect the cellular and molecular mechanisms of remission maintenance and joint flares in in vivo and in vitro systems

Time frame: months 13-36