PrOb-MDR-RA

• Research type

  Research Study

• Full title

  Defining clinical and molecular phenotypes in the Prospective Observational MDR-RA cohort study and all-encompassing Biomedical Resource (PrOb-MDR-RA)

• IRAS ID

  353091

• Contact name

• Contact email

  emrclinicaltrials.ac.uk

• Sponsor organisation

  Humanitas University

• Duration of Study in the UK

  2 years, 5 months, 30 days

• Research summary

  This study, PrOb-MDR-RA, is a multicenter, observational research project focusing on patients with difficult-to-treat rheumatoid arthritis (RA). It aims to collect clinical data, synovial tissue, and blood samples from 80 participants across European rheumatology centers, including sites in the UK. The purpose is to better understand the clinical and molecular characteristics of multi-drug-resistant RA (MDR-RA) and develop personalized treatment approaches.

  Synovial biopsies will be performed as part of routine clinical care, and a portion of these samples, along with blood samples, will be used for research. The study will also collect anonymized clinical and demographic data to create a comprehensive dataset. This research seeks to identify biological signatures of treatment resistance, validate findings from earlier studies, and contribute to the development of future care models for MDR-RA patients.

  Participation involves baseline data and sample collection during synovial biopsy, followed by routine follow-up visits at 3, 6, 9, and 12 months. The study complies with Good Clinical Practice and ethical guidelines, ensuring patient confidentiality and voluntary participation.

• REC name

  West Midlands - Solihull Research Ethics Committee

• REC reference

  25/WM/0139

• Date of REC Opinion

  16 Jul 2025

• REC opinion

  Favourable Opinion