CReMSIA (Ethics renewal 2022)
Research type
Research Database
IRAS ID
315018
Contact name
Costantino Pitzalis
Contact email
Research summary
Clinical Records Management System for inflammatory arthritis
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0117
Date of REC Opinion
28 Jul 2022
REC opinion
Further Information Favourable Opinion
Data collection arrangements
The CReMSIA database proposed intends to act as a central repository for all clinical data collected within clinical trials within the department of Rheumatology, Barts Health NHS Trust led by Experimental Medicine and Rheumatology for which QMUL is the study sponsor.
The intention would be to continue to follow these patients on their return to routine NHS hospital rheumatology clinic, collecting data recorded within routine follow up visits. Data collected may include but not be limited to:
Disease activity Scores, SF36, HAQ, EQ5D, Global health scores
Blood results including but not limited to: Haematology, Immunology, biochemistry, microbiology
Imaging of all modalities: raw images and reports
Healthcare utilisation: appointments and admissions for treatments (planned and unplanned)
Data collected in other ethically approved clinical studies would be collated for patients who are also enrolled in CReMSIA. This would include laboratory and bedside data related to the patients’ disease.Research programme
This cohort of patients is relatively unique and the opportunity to track the progress of patients over the course of their disease gives a unique opportunity to determine the value of synovial tissue as a marker of response to therapy and disease progression. All patients entering clinical trials within the participating centres will be invited to join the database to enable ongoing collection of data as part of routine follow up following exit from an Experimental Medicine and Rheumatology (EMR) department-led clinical trial. The database would offer a unique opportunity to compare previously collected study samples with disease progression and response/non-response to treatment. Additionally, the database will allow the comparison of long-term clinical outcomes of patients participating to the research studies with standard of care (patients routinely treated in NHS/hospital clinics).
Research database title
Clinical Records Management System for inflammatory arthritis
Establishment organisation
Centre for Experimental Medicine & Rheumatology, Queen Mary University of London
Establishment organisation address
2nd Floor John Vane Science Centre, William Harvey Research Institute
Barts and the London School of Medicine
EC1M 6BQ