A Phase 2/3 interventional study of Treatment of MTX and Treatment of MTX and TwHF in Rheumatoid Arthritis, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Status unknown. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-10-27.
Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Phase 2/3, Interventional, and Treatment
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: treatment of MTX Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.Experimental: treatment of TwHF Patients were treated with methotrexate (MTX) and Tripterygium wilfordii Hook F（TwHF).
Exclusion Criteria:
Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.
Drug: Treatment of MTX
Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF).
Drug: Treatment of MTX and TwHF
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.
Methotrexate : 10-15mg per week according to patient's weight, oral, for 24 weeks.Tripterygium wilfordii Hook F（TwHF）：20mg， 3 times a day, oral, for 24 weeks.
The change from Baseline to week 24 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 score
The change in X-Ray from baseline to week 24 and 52.
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences