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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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