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

Rheumatoid Arthritis Clinical Trial

Official title:

Synovial Tissue and Blood Signature to Personalize the Management of Rheumatoid Arthritis Patients With Disease Flare After Biological DMARDs Discontinuation for Sustained Remission.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05767801
• Other study ID #: 2667
• Status: Active, not recruiting
• Start date: November 15, 2019
• Est. completion date: March 14, 2023

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 14, 2023
• Est. primary completion date: March 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Procedure:
• 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;

Locations

Country	Name	City	State
Italy	UOC Reumatologia - Policlinico di Bari	Bari	Puglia
Italy	Centro di Ricerca E. Menni - Fondazione Poliambulanza Brescia	Brescia	Lombardia
Italy	Division of Rheumatology	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease flare rate		24 months