Topical Compound Tripterygium Wilfordii Hook F for Patients With Active Rheumatoid Arthritis

A Randomized Controlled Study to Determine the Effects and Safety of Topical Compound Tripterygium Wilfordii Hook F in Patients With Active Rheumatoid Arthritis.

Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tripterygium wilfordii Hook F has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a prospective randomized controlled study to evaluated the efficacy and safety of external application with compound Tripterygium wilfordii Hook F in treating of patients with rheumatoid arthritis (RA).

Inclusion Criteria:

• Documented diagnosis of rheumatoid arthritis, as defined by the American Rheumatism Association 1987 Revised Criteria or European League Against Rheumatism criteria (2009).
• Patients must have moderately to severely active RA,and the DAS-28 score should be from 3.2 to 5.1.
• If taking disease modifying antirheumatic drug (DMARDs)(e.g.Methotrexate), subject must have been on a stable dose for ≥ 3 months prior to randomization.
• If taking non-steroidal anti-inflammatory drugs (NSAIDs), subject must have been on a stable dose for ≥ 4 weeks prior to randomization.
• 16 to 65 years old, having signed the informed consent.

Exclusion Criteria:

• Patients who have skin burst or allergies.
• Patients with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system.
• Patients who have been treated by tripterygium, hormones or biological agents.
• Patients who have not been treated by DMARDs before.
• Patients who are unwilling to comply with all study procedures.