ISRCTN16371380Completed未知

BIOlogical Factors that Limit sustAined Remission in rhEumatoid arthritis (the BIO-FLARE study)

The Newcastle Upon Tyne Hospitals NHS Foundation Trust0 sites137 target enrollmentStarted: June 27, 2019Last updated: January 8, 2024

Conditions

Trial Snapshot

No summary available.

•1. Diagnosis of rheumatoid arthritis according to the 1987 ACR or 2010 ACR/EULAR classification criteria (applied at any time since diagnosis)
•2. Current single or combination use of methotrexate, sulfasalazine and/or hydroxychloroquine. No escalations in dose are permitted in the six months prior to enrolment, although dose reductions in this time are permitted
•3. Arthritis currently in remission, as judged clinically by referring healthcare professional
•4. Patient and referring clinician willing to consider DMARD withdrawal
•5. Age > 16 at time of first diagnosis with RA, and > 18 at time of recruitment

•1. Inability to provide informed consent
•2. Current participation or follow-up within another ongoing clinical interventional trial
•3. Current pregnancy, or pregnancy planned within next 6 months
•4. Major surgery planned within next 6 months (definition of major surgery at discretion of screening clinician)
•5. Immunisation within the past 4 weeks
•6. Received steroids within past 3 months (oral, parenteral or intra-articular)
•7. Use of any DMARD other than methotrexate, sulfasalazine or hydroxychloroquine within the past 6 months (or past 12 months for leflunomide)
•8. Increase in the dose of any DMARD in the 6 months prior to screening.
•9. Use of biologic therapy within the past 6 months
•10. Prior use of cell-depleting biologic therapies
•11. Haemoglobin < 9g/L at baseline
•12. Contraindication to synovial biopsy – e.g. bleeding diathesis or prolonged use of anticoagulant therapy (warfarin or other direct oral anticoagulants e.g. rivaroxaban)
•13. Active crystal arthropathy
•*Topical, inhaled and intra-nasal steroids are permitted

Sponsor