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

NCT05767801 | Unknown

• 1 other identifier: 2667
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

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

Keywords

synovial tissue; disease flare; sustained remission; peripheral blood

Outcome Measures

Primary Outcomes (1)

• Disease flare rate

  24 months

Study Arms (2)

RA patients in sustained clinical and ultrasound remission not changing treatment

Procedure: Evaluation of subclinical inflammation

RA patients in sustained clinical and ultrasound remission changing treatment

Procedure: Evaluation of subclinical inflammation

Interventions

Evaluation of subclinical inflammation 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; RA patients in sustained clinical and ultrasound remission not changing treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Rheumatoid Arthritis in stable remission (DAS\<1.6 for at least 6 months) and under treatment with stable dose of conventional, synthetic or biological DMARDs. All patients at the time of enrolment must fulfil the ultrasound criteria of Power Doppler negativity of knee, wrist, II-V MCP and II-V MTP bilaterally and any other reported painful joint not included in the screening ultrasound protocol.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (3)

UOC Reumatologia - Policlinico di Bari

Bari, Apulia, 70100, Italy

Location

Centro di Ricerca E. Menni - Fondazione Poliambulanza Brescia

Brescia, Lombardy, 25121, Italy

Location

Division of Rheumatology

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 14, 2023
• Study Start: November 15, 2019
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)