Dissecting the Cellular and Molecular Atlas of Rheumatoid Arthritis in Sustained Remission to Identify Pathways Maintaining Remission and Triggering Flares
NCT ID: NCT05952440
Last Updated: 2023-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
130 participants
OBSERVATIONAL
2023-07-11
2026-05-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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RA in remission who performed synovial biopsy before treatment change
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
RA in remission eligible to synovial biopsy before treatment change
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
Subjects asymptomatic for joint inflammation without ACPA/RF positivity
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion 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
* Presence of Power-Doppler signal ≥1 at ultrasound assessment (wrist, MCP, PIP, Knee, ankle and II-V MTP bilaterally)
* Other chronic inflammatory disease
18 Years
80 Years
ALL
No
Sponsors
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University of Glasgow
OTHER
Fundacion Clinic per a la Recerca Biomédica
OTHER
Newcastle University
OTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Locations
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Division of Rheumatology
Rome, , Italy
Hospital Clinic and Fundació Clinic per la Recerca Biomèdica
Barcelona, , Spain
Research into Inflammatory Arthritis Centre Versus Arthritis (RACE)
Glasgow, , United Kingdom
Newcastle University
Newcastle upon Tyne, , United Kingdom
Countries
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Facility Contacts
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Other Identifiers
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5600
Identifier Type: -
Identifier Source: org_study_id
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