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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05952440

Acronym

FLARE-RA

Enrollment

130

Registered

2023-07-19

Start date

2023-07-11

Completion date

2026-05-10

Last updated

2023-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

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

After synovial tissue biopsy, pharmacological treatment (cDMARDs or bDMARDs) are tapered first and then bDMARDs and/or cDMARDs are discontinued based on AI-guidance

OTHERNo tapering and/or discontinuation of treatment based on AI-guidance

Ongoing therapeutic are not changed (tapered or discontinued) after synovial biopsy performance based on AI-guidance

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

After synovial tissue biopsy, pharmacological treatment (cDMARDs or bDMARDs) are tapered first and then bDMARDs and/or cDMARDs are discontinued based on standard of care

OTHERNo tapering and/or discontinuation of treatment based on standard of care

Ongoing therapeutic are not changed (tapered or discontinued) after synovial biopsy performance based on standard of care

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Establishment of cellular and molecular atlas of remission RA	months 1-12	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.

Secondary

Measure	Time frame	Description
To test the performance of a ML-derived algorithm on longitudinal remission RA cohort in a biopsy-driven study.	months 13-36	To test the performance of a ML-derived algorithm on longitudinal remission RA cohort in a biopsy-driven study.
To dissect the cellular and molecular mechanisms of remission maintenance and joint flares	months 13-36	To dissect the cellular and molecular mechanisms of remission maintenance and joint flares in in vivo and in vitro systems

Countries

Italy, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026