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

Rheumatoid Arthritis Clinical Trial

— FLARE-RA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05952440
• Other study ID #: 5600
• Status: Recruiting
• Start date: July 11, 2023
• Est. completion date: May 10, 2026

Study information

• Verified date: May 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: May 10, 2026
• Est. primary completion date: May 10, 2026
• Gender: All
• Age group: 18 Years to 80 Years

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Tapering 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
• No 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
• Tapering 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
• No 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

Locations

Country	Name	City	State
Italy	Division of Rheumatology	Rome
Spain	Hospital Clinic and Fundació Clinic per la Recerca Biomèdica	Barcelona
United Kingdom	Research into Inflammatory Arthritis Centre Versus Arthritis (RACE)	Glasgow
United Kingdom	Newcastle University	Newcastle Upon Tyne

Sponsors (4)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Fundacion Clinic per a la Recerca Biomédica, Newcastle University, University of Glasgow

Countries where clinical trial is conducted

Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishment of cellular and molecular atlas of remission RA	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.	months 1-12
Secondary	To test the performance of a ML-derived algorithm on longitudinal remission RA cohort in a biopsy-driven study.	To test the performance of a ML-derived algorithm on longitudinal remission RA cohort in a biopsy-driven study.	months 13-36
Secondary	To dissect the cellular and molecular mechanisms of remission maintenance and joint flares	To dissect the cellular and molecular mechanisms of remission maintenance and joint flares in in vivo and in vitro systems	months 13-36