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

Recruiting
18 - 80 years of age
Both
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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