Dissecting the Cellular and Molecular Atlas of Rheumatoid Arthritis in Sustained Remission to Identify Pathways Maintaining Remission and Triggering Flares (FLARE-RA)

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

Rheumatoid Arthritis

Treatments

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

Other: No tapering and/or discontinuation of treatment based on AI-guidance

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

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

Study type

Observational

Funder types

Other

Identifiers

NCT05952440

5600

Details and patient eligibility

About

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.

Enrollment

130 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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