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

July 20, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Clinic and Fundació Clinic per la Recerca Biomèdica
        • Contact:
  • United Kingdom
      • Glasgow, United Kingdom
        • Active, not recruiting
        • Research into Inflammatory Arthritis Centre Versus Arthritis (RACE)
      • Newcastle Upon Tyne, United Kingdom
        • Active, not recruiting
        • Newcastle University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Experimental groups will include, the following classes of patients:

  1. Rheumatoid Arthritis in sustained clinical and ultrasound remission afferent to the Division of Rheumatology - Fondazione Policlinico Universitario A. Gemelli IRCCS, in Rome who already underwent synovial tissue biopsy for the routine clinical assessment of tissue inflammation (retrospective cohort) (n=40).
  2. Rheumatoid Arthritis in sustained clinical and ultrasound remission afferent to the Division of Rheumatology - Fondazione Policlinico Universitario A. Gemelli IRCCS, in Rome or to the Hospital Clinic and Fundació Clinic per la Recerca Biomèdica, in Barcelona eligible to synovial tissue biopsy for the routine clinical assessment of tissue inflammation (prospective cohort) (n=40 for each center).
  3. Subjects asymptomatic for joint inflammation without ACPA/RF positivity (n=10) (University of Glasgow).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RA in remission who performed synovial biopsy before treatment change
Other: 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
Other: 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
RA in remission eligible to synovial biopsy before treatment change
Other: 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
Other: 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
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
Other: 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
Subjects asymptomatic for joint inflammation without ACPA/RF positivity

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

Fundacion Clinic per a la Recerca Biomédica
Newcastle University
University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2023

Primary Completion (Estimated)

May 10, 2026

Study Completion (Estimated)

May 10, 2026

Study Registration Dates

First Submitted

July 11, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5600

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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