BIO-FLARE: to improve understanding of why some people with rheumatoid arthritis experience flares, and what is happening to the joint when they occur

Not Applicable

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases; Rheumatoid arthritis, unspecified

• Registration Number: ISRCTN16371380
• Lead Sponsor: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-27
• Study Completion: 2021-06-30
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified