The BIO-FLARE study version 1.0
Research type
Research Study
Full title
BIOlogical Factors that Limit sustAined Remission in rhEumatoid arthritis (the BIO-FLARE study)
IRAS ID
234030
Contact name
Sinead Magorrian
Contact email
Sponsor organisation
Newcastle upon Tyne NHS Foundation Trust
Clinicaltrials.gov Identifier
8131, The Newcastle upon Tyne Hospitals NHS Foundation Trust R&D Ref Number
Duration of Study in the UK
2 years, 6 months, 3 days
Research summary
Rheumatoid arthritis is a relapsing and remitting autoimmune disease. The challenge that we will address is why immune-mediated inflammatory diseases (IMIDs) remit and relapse. Whilst a considerable amount is understood about factors which may contribute to development of RA and about disease mechanisms, nothing is known of the factors that trigger disease relapses (flares), converting the disease from an inactive to an active state. The underpinning mechanism(s) of flare have been difficult to study because they occur unpredictably. By studying patients who flare, we will attempt to capture signals that may determine which patients are most likely to flare, as well as understanding the biology behind the phenomenon of flare itself. This may eventually lead to future work on treatable targets in disease management.
In this study, we will recruit patients in remission from RA on traditional disease modifying therapies (DMARDs), namely methotrexate, sulfasalazine, and/or hydroxychloroquine. These patients will then discontinue their DMARDs and be closely followed-up by the research team. Previous research suggests 50% will experience flare, while the remainder will remain in remission. They will have regular assessment of their disease activity (physical examination and questionnaires), along with clinical and research blood samples taken. Urine samples will be taken at each visit. If a patient in the study experiences a flare, they will have an ultrasound-guided synovial biopsy taken under local anaesthetic. Samples of blood, urine and synovium (joint lining) will be analysed for gene expression, synovial cell subtypes, molecular pathways, immune cell profiles, and antibody status.
After 6 months, if a patient does not experience a flare, they will be referred back to their usual rheumatologist and may be able to remain off of DMARDs. If a patient experiences flare at any time, they will receive steroid treatment and be referred back to their usual rheumatologist to restart their DMARDs.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0386
Date of REC Opinion
6 Feb 2018
REC opinion
Further Information Favourable Opinion