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

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

Recruiting
18-80 years
All
Phase N/A

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Overview

The FLARE-RA study will have the following research objectives:

  1. 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.
  2. To test the performance of a ML-derived algorithm on longitudinal remission RA cohort in a biopsy-driven study.
  3. To dissect the cellular and molecular mechanisms of remission maintenance and joint flares.

Eligibility

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

Study details
    Rheumatoid Arthritis

NCT05952440

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

25 January 2024

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