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 has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a multicenter ,double Blind, randomized study to evaluated the efficacy and safety of Tripterygium Wilfordii in treating of patients with rheumatoid arthritis (RA) and establish a prediction model for Tripterygium Wilfordii response of rheumatoid arthritis (RA).
Two arms were included in this study. Active Comparator: Patients were treated with Methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.Experimental:Patients were treated with Methotrexate (MTX) placebo and Tripterygium wilfordii Hook F（TwHF)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
264
Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks.Tripterygium wilfordii Hook F（TwHF）placebo：20mg,3 times a day, oral, for 24 weeks.
Tripterygium wilfordii Hook F（TwHF)：20mg,3 times a day, oral, for 24 weeks.Methotrexate (MTX)placebo: 10-15mg per week according to patient's weight, oral, for 24 weeks.
Guang'anmen Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe change in Disease Activity Score (DAS28)
Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4\[ESR\])
Time frame: 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks
The proportion of patients achieving ACR20/50/70
ACR20/50/70 is referred to American College of Rheumatology Criteria
Time frame: 0 weeks, 4 weeks，12 weeks, 24 weeks
The change in Health Assessment Questionnaire (HAQ) score
HAQ scores ranges from 0 to 3, with higher scores indicating greater disability
Time frame: 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks
The change in Sharp scoring system of van der Heijde(Sharp) score
The change in Sharp score from baseline to week 24 and 52.According to the revised Sharp scoring system of van der Heijde, the joint gap score was scored in 30 regions of the hands (score range 0-120 points), and the bone erosion score was conducted in 32 areas (score range 0-160).The higher the score, the more serious the joint destruction.
Time frame: 0 week,24 weeks,52 weeks
The number of adverse events
The number of adverse events that are related to treatment
Time frame: 24 weeks
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