NCT05952440

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
3 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 11, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2026

Completed
Last Updated

July 21, 2023

Status Verified

May 1, 2023

Enrollment Period

2.8 years

First QC Date

July 11, 2023

Last Update Submit

July 20, 2023

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

    months 13-36

Study Arms (3)

RA in remission who performed synovial biopsy before treatment change

Other: Tapering and/or discontinuation of treatment based on standard of careOther: No tapering and/or discontinuation of treatment 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-guidanceOther: No tapering and/or discontinuation of treatment based on AI-guidanceOther: Tapering and/or discontinuation of treatment based on standard of careOther: No tapering and/or discontinuation of treatment based on standard of care

Subjects asymptomatic for joint inflammation without ACPA/RF positivity

Interventions

Tapering and/or discontinuation of treatment based on AI-guidanceOTHER

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

RA in remission eligible to synovial biopsy before treatment change
No tapering and/or discontinuation of treatment based on AI-guidanceOTHER

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

RA in remission eligible to synovial biopsy before treatment change
Tapering and/or discontinuation of treatment based on standard of careOTHER

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

RA in remission eligible to synovial biopsy before treatment changeRA in remission who performed synovial biopsy before treatment change
No tapering and/or discontinuation of treatment based on standard of careOTHER

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 changeRA in remission who performed synovial biopsy before treatment change

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Division of Rheumatology

Rome, 00168, Italy

RECRUITING

Hospital Clinic and Fundació Clinic per la Recerca Biomèdica

Barcelona, Spain

NOT YET RECRUITING

Research into Inflammatory Arthritis Centre Versus Arthritis (RACE)

Glasgow, United Kingdom

ACTIVE NOT RECRUITING

Newcastle University

Newcastle upon Tyne, United Kingdom

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 19, 2023

Study Start

July 11, 2023

Primary Completion

May 10, 2026

Study Completion

May 10, 2026

Last Updated

July 21, 2023

Record last verified: 2023-05

Locations

GB(2)ES(1)IT(1)