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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
201
Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.
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.
Deptment of Rheumatology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
ACR50
The proportion of patients achieving ACR50.
Time frame: 24 weeks.
Radiology outcome
The change in X-Ray from baseline to week 24.
Time frame: 24 weeks
DAS28
The change in DAS score from baseline to week 24.
Time frame: 24 weeks
ACR20/70
The proportion of patients achieving ACR20 \& ACR70.
Time frame: 24 weeks
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