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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
View:

• 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.

Locations
Other Locations
Italy
Division of Rheumatology
RECRUITING
Rome
Spain
Hospital Clinic and Fundació Clinic per la Recerca Biomèdica
NOT_YET_RECRUITING
Barcelona
United Kingdom
Research into Inflammatory Arthritis Centre Versus Arthritis (RACE)
ACTIVE_NOT_RECRUITING
Glasgow
Newcastle University
ACTIVE_NOT_RECRUITING
Newcastle Upon Tyne
Time Frame
Start Date: 2023-07-11
Estimated Completion Date: 2026-05-10
Participants
Target number of participants: 130
Treatments
RA in remission who performed synovial biopsy before treatment change
RA in remission eligible to synovial biopsy before treatment change
Subjects asymptomatic for joint inflammation without ACPA/RF positivity
Sponsors
Collaborators: Newcastle University, Fundacion Clinic per a la Recerca Biomédica, University of Glasgow
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov

Similar Clinical Trials