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

Last updated: July 20, 2023
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arthritis And Arthritic Pain

Rheumatoid Arthritis

Joint Injuries

Treatment

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

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

No tapering and/or discontinuation of treatment based on standard of care

Clinical Study ID

NCT05952440
5600
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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, ankleand II-V MTP bilaterally) in 3 evaluations 3 months apart.

Exclusion

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 Design

Total Participants: 130
Treatment Group(s): 4
Primary Treatment: Tapering and/or discontinuation of treatment based on AI-guidance
Phase:
Study Start date:
July 11, 2023
Estimated Completion Date:
May 10, 2026

Connect with a study center

  • Division of Rheumatology

    Rome, 00168
    Italy

    Active - Recruiting

  • Hospital Clinic and Fundació Clinic per la Recerca Biomèdica

    Barcelona,
    Spain

    Site Not Available

  • Research into Inflammatory Arthritis Centre Versus Arthritis (RACE)

    Glasgow,
    United Kingdom

    Site Not Available

  • Newcastle University

    Newcastle Upon Tyne,
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.