Status:
WITHDRAWN
The Use of Synovial Biopsies in Predicting Response to Biologic Therapy in Rheumatoid Arthritis Patients
Lead Sponsor:
Abu Dhabi Stem Cells Center
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
SYBRA is an open-label, phase 3, randomized controlled clinical trial that aims to assess the use of synovial biopsies in predicting response to biologic therapy in patients with rheumatoid arthritis ...
Eligibility Criteria
Inclusion
- Subject should be capable of consent
- Age 18 and older
- Classified as rheumatoid arthritis as per EULAR/ACR criteria 2010
- Failed one DMARD (Methotrexate, leflunomide, Sulfalsalazine, hydroxychloroquine)
- Can be on steroid dose \<7.5mg
- Quantiferon negative
- Hepatitis B, C negative
- No recent history (\<5y) of malignancy
Exclusion
- Overlap syndrome
- Previously treated with a biological medication
- Heart failure NYHA III/IV
- Active tuberculosis
- Active infections
- Previous history of DVT, PE, or Stroke
- Other significant comorbidities that will prevent them from taking any biologic medication as per EULAR guidelines on treating rheumatoid arthritis 2020.
- Pregnancy
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05379322
Start Date
March 1 2023
End Date
March 1 2023
Last Update
October 6 2025
Active Locations (1)
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1
Abu Dhabi Stem Cells Center
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 4600