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

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ClinicalTrials.gov Identifier: NCT05952440
Recruitment Status : Recruiting
First Posted : July 19, 2023
Last Update Posted : July 21, 2023
Sponsor:
Collaborators:
University of Glasgow
Fundacion Clinic per a la Recerca Biomédica
Newcastle University
Information provided by (Responsible Party):
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Description
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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.


Condition or disease Intervention/treatment
Rheumatoid Arthritis Other: Tapering and/or discontinuation of treatment based on AI-guidance Other: No tapering and/or discontinuation of treatment based on AI-guidance Other: Tapering and/or discontinuation of treatment based on standard of care Other: No tapering and/or discontinuation of treatment based on standard of care

Study Design
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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Dissecting the Cellular and Molecular Atlas of Rheumatoid Arthritis in Sustained Remission to Identify Pathways Maintaining Remission and Triggering Flares
Actual Study Start Date : July 11, 2023
Estimated Primary Completion Date : May 10, 2026
Estimated Study Completion Date : May 10, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 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

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
Subjects asymptomatic for joint inflammation without ACPA/RF positivity


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05952440


Locations
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Italy
Division of Rheumatology Recruiting
Rome, Italy, 00168
Contact: Stefano Alivernini, MD, PhD    00390630154503    stefano.alivernini@policlinicogemelli.it   
Spain
Hospital Clinic and Fundació Clinic per la Recerca Biomèdica Not yet recruiting
Barcelona, Spain
Contact: Juan D Canete       jcanete@clinic.cat   
United Kingdom
Research into Inflammatory Arthritis Centre Versus Arthritis (RACE) Active, not recruiting
Glasgow, United Kingdom
Newcastle University Active, not recruiting
Newcastle Upon Tyne, United Kingdom
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
University of Glasgow
Fundacion Clinic per a la Recerca Biomédica
Newcastle University
More Information
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Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT05952440    
Other Study ID Numbers: 5600
First Posted: July 19, 2023    Key Record Dates
Last Update Posted: July 21, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases