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

Active, not recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Procedure: Evaluation of subclinical inflammation

• Registration Number: NCT05767801
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-15
• Primary Completion: 2022-03-14
• Status Verified: 2023-03
• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-02
• Last Update Submitted: 2023-03-02
• Study Completion: 2023-03-14
• Study First Posted: 2023-03-14
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RA patients in sustained clinical and ultrasound remission not changing treatment	Evaluation of subclinical inflammation	-
RA patients in sustained clinical and ultrasound remission changing treatment	Evaluation of subclinical inflammation	-

Primary Outcome Measures

Name	Time	Method
Disease flare rate	24 months

Trial Locations

Locations (3)

Centro di Ricerca E. Menni - Fondazione Poliambulanza Brescia; 🇮🇹 Brescia, Lombardia, Italy

UOC Reumatologia - Policlinico di Bari; 🇮🇹 Bari, Puglia, Italy

Division of Rheumatology; 🇮🇹 Rome, Italy