Clinical trial NCT05952440: Dissecting the Cellular and Molecular Atlas of Rheumatoid Arthritis in Sustained Remission to Identify Pathways Maintaining Remission and Triggering Flares
Official title: Dissecting the Cellular and Molecular Atlas of Rheumatoid Arthritis in Sustained Remission to Identify Pathways Maintaining Remission and Triggering Flares
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: Fundacion Clinic per a la Recerca Biomédica
name: Newcastle University
First posted: 2023-07-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
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).

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.


Eligibility 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

Primary outcomes:
measure: Establishment of cellular and molecular atlas of remission RA
timeFrame: months 1-12
Secondary outcomes:
measure: To test the performance of a ML-derived algorithm on longitudinal remission RA cohort in a biopsy-driven study.
timeFrame: months 13-36
measure: To dissect the cellular and molecular mechanisms of remission maintenance and joint flares
timeFrame: months 13-36
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Division of Rheumatology
city: Barcelona
country: Spain
facility: Hospital Clinic and Fundació Clinic per la Recerca Biomèdica
city: Glasgow
country: United Kingdom
facility: Research into Inflammatory Arthritis Centre Versus Arthritis (RACE)
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle University
Study officials:
References: