drugset / Trial / NCT01613079

Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis

NCT01613079 ↗

Phase 2/3 Completed 201 enrolled Peking Union Medical College Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-05
Primary completion
2013-06
Completion
2013-06

Outcome

Met primary endpoint

paper TwHF monotherapy was not inferior to, and MTX+TwHF was better than, MTX monotherapy PMID 24733191 ↗

paper TwHF vs MTX monotherapy, p=0.014; MTX+TwHF vs MTX monotherapy, p<0.001 PMID 24733191 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Methotrexate Small molecule 12.5 mg Oral
Subject Tripterygium wilfordii Hook F Traditional medicine (herbal / TCM) 20 mg Oral

Indications