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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05767801
Collaborator
(none)
200
3
39.9
66.7
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Evaluation of subclinical inflammation

Study Design

Study Type:
Observational
Actual Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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.
Actual Study Start Date :
Nov 15, 2019
Actual Primary Completion Date :
Mar 14, 2022
Anticipated Study Completion Date :
Mar 14, 2023

Arms and Interventions

Arm Intervention/Treatment
RA patients in sustained clinical and ultrasound remission not changing treatment

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;

RA patients in sustained clinical and ultrasound remission changing treatment

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;

Outcome Measures

Primary Outcome Measures

  1. Disease flare rate [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centro di Ricerca E. Menni - Fondazione Poliambulanza Brescia Brescia Lombardia Italy 25121
2 UOC Reumatologia - Policlinico di Bari Bari Puglia Italy 70100
3 Division of Rheumatology Rome Italy 00168

Sponsors and Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alivernini Stefano, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT05767801
Other Study ID Numbers:
  • 2667
First Posted:
Mar 14, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alivernini Stefano, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2023