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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

Conditions: Rheumatoid Arthritis

Treatments: Procedure: Evaluation of subclinical inflammation

Study type: Observational

Funder types: Other

Identifiers

NCT05767801

2667

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

RA patients in sustained clinical and ultrasound remission not changing treatment

Treatment:

Procedure: Evaluation of subclinical inflammation

RA patients in sustained clinical and ultrasound remission changing treatment

Treatment:

Procedure: Evaluation of subclinical inflammation