Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of RA patients with clinical efficacy and safety.Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Age 18-65 years with informed consent

• Diagnosed with rheumatoid arthritis as determined by meeting the 2010 ACR/EULAR classification criteria and has had rheumatoid arthritis for at least 6 weeks

• Swollen joint (SJC)≥3 and tender joint count(TJC)≥5

• ESR >28 mm/hr or C-reactive protein > 20 mg/L

Exclusion Criteria:

• Pregnant, lactating or further fertility requirements

• Previous treated with methotrexate or biologic DMARD.

• Active or chronic infection, including HIV, HCV, HBV, tuberculosis

• Patient with cancer