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

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abu Dhabi Stem Cells Center
• Treatments: Adalimumab; Etanercept; Golimumab; Janus Kinase Inhibitors; Tofacitinib; Upadacitinib

Criteria

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