NCT01613079

Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis

Evaluation of Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of RA Patients With Clinical Efficacy and Safety.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Tripterygium wilfordii Hook F	Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.
DRUG	Methotrexate	Oral methotrexate 7.5-12.5mg per week for 24 weeks. The starting dose was 7.5mg per week, then increased to 12.5mg（max 0.3mg/Kg） per week in 4 weeks. Folic acid at the dose of 10mg per week were applied to all patients.

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-06-06
• Last updated: 2013-08-05

Locations

1 site across 1 country: China