Synovial Tissue and Blood Signature of Rheumatoid Arthritis Patients With Disease Flare After Treatment Discontinuation for Sustained Remission.

NCT ID: NCT05767801

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2023-03-14

Brief Summary

Flares of immune-mediated inflammatory diseases, as Rheumatoid Arthritis (RA), are a major burden for patients in routine care. They occur unpredictably, adding to the physical and psychological burden of the condition. In this study we will deeply dissect the synovial tissue and peripheral blood signature of RA in sustained remission eligible to treatment discontinuation to better understand the individualized factors determining disease flare once biological treatment is discontinued. We expect that the combined study of synovial tissue, imaging and peripheral blood derived biomarkers, associated with disease flare after treatment discontinuation in RA in remission, will provide a tool for the routine assessment of RA eligible to treatment discontinuation reducing the relapse rate and increasing the optimization of the use of expensive pharmacological treatments only for patients still needing them.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

RA patients in sustained clinical and ultrasound remission not changing treatment

Evaluation of subclinical inflammation

Intervention Type: PROCEDURE

Minimally invasive synovial tissue biopsy for the semiquantitative and qualitative assessment of synovial immune and stromal cells; Peripheral blood collection for MBDA assessment and phenotyping of immune cells;

RA patients in sustained clinical and ultrasound remission changing treatment

Evaluation of subclinical inflammation

Intervention Type: PROCEDURE

Minimally invasive synovial tissue biopsy for the semiquantitative and qualitative assessment of synovial immune and stromal cells; Peripheral blood collection for MBDA assessment and phenotyping of immune cells;

Interventions

Evaluation of subclinical inflammation

Minimally invasive synovial tissue biopsy for the semiquantitative and qualitative assessment of synovial immune and stromal cells; Peripheral blood collection for MBDA assessment and phenotyping of immune cells;

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of RA following the 2010 ACR/EULAR classification criteria
• Age ≥18 and ≤75 years
• Sustained remission (DAS<1.6 for at least 3 sequential evaluations 6months apart).
• Without evidence of ultrasound detected synovitis (Power Doppler negative in knee, wrist, II-V MCP, II-V PIP and II-V MTP bilaterally).
• Patients under treatment with stable dose of conventional, synthetic or biological DMARDs.
• Patients without steroid treatment in the last 6 months.

Exclusion Criteria

• With other diagnosis of chronic joint diseases rather than RA.
• Unable to participate to the clinical outpatient follow-up.
• Exposed to steroid treatment within 6 months from study screening.
• With evidence of ultrasound detected synovitis (Power Doppler positivity) in other joints than the ones included in the screening visit.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Alivernini Stefano

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UOC Reumatologia - Policlinico di Bari

Bari, Apulia, Italy

Centro di Ricerca E. Menni - Fondazione Poliambulanza Brescia

Brescia, Lombardy, Italy

Division of Rheumatology

Rome, , Italy

Countries

Italy

Other Identifiers

2667

Identifier Type: -

Identifier Source: org_study_id