The Use of Synovial Biopsies in Predicting Response to Biologic Therapy in Rheumatoid Arthritis Patients

The Use of Synovial Biopsies in Predicting Response to Biologic Therapy in Rheumatoid Arthritis Patients

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 that have failed disease-modifying drugs. The project has the potential to help change the current practice by offering the best treatment option. The decision to choose the best treatment for a particular patient is especially important in the context of the growing number of therapies available as a first-line option and the lack of specific biomarkers to predict response to treatment.

Inclusion Criteria:

• 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 Criteria:

• 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