Exploring the cellular and molecular aspects of rheumatoid arthritis in remission
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 IRCCS · NCT05952440
This study is trying to understand the cells and molecules in people with rheumatoid arthritis who are feeling good to see what keeps them that way and how to predict when their symptoms might come back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 4 sites (Rome and 3 other locations) |
| Trial ID | NCT05952440 on ClinicalTrials.gov |
What this trial studies
The FLARE-RA study aims to create a detailed cellular and molecular atlas of rheumatoid arthritis (RA) patients who are in sustained remission. It will identify specific cell clusters and pathways that contribute to either maintaining remission or triggering disease flares. Additionally, the study will evaluate the effectiveness of a machine learning algorithm designed to predict flares based on longitudinal data from a biopsy-driven cohort. The research will involve various treatment approaches, including tapering and discontinuation guided by AI or standard care.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with rheumatoid arthritis who have been in stable remission for at least six months and are on stable treatment with disease-modifying antirheumatic drugs.
Not a fit: Patients who are currently experiencing disease activity or have other chronic inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for rheumatoid arthritis, helping to maintain remission and prevent disease flares.
How similar studies have performed: Other studies have shown promise in using machine learning approaches to predict disease flares in chronic conditions, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rome and 3 other locations
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rheumatoid Arthritis