Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05952440 | RECRUITING | Rheumatoid Arthritis

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

Agostino Gemelli IRCCS University Polyclinic University Foundation

Brief 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.

Condition or disease

Rheumatoid Arthritis

Intervention/treatment

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

No 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

Study Type : OBSERVATIONAL
Estimated Enrollment : 130 participants
Official Title : Dissecting the Cellular and Molecular Atlas of Rheumatoid Arthritis in Sustained Remission to Identify Pathways Maintaining Remission and Triggering Flares
Actual Study Start Date : 2023-07-11
Estimated Primary Completion Date : 2026-05-10
Estimated Study Completion Date : 2026-05-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
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
Dissecting the Cellular and Molecular Atlas of Rheumatoid Arthritis in Sustained Remission to Identify Pathways Maintaining Remission and Triggering Flares

Location Details

NCT05952440

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Italy,

Division of Rheumatology

Rome, Italy, 00168

NOT YET RECRUITING

Spain,

Clinic Hospital and Clinic Foundation for Biomedical Research

Barcelona, Spain,

ACTIVE NOT RECRUITING

United Kingdom,

Research into Inflammatory Arthritis Centre Versus Arthritis (RACE)

Glasgow, United Kingdom,

ACTIVE NOT RECRUITING

United Kingdom,

Newcastle University

Newcastle Upon Tyne, United Kingdom,