A Specification Clinical Application Research of Tripterygium Wilfordii Treating Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT03337815|
Recruitment Status : Unknown
Verified November 2017 by Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was: Recruiting
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Treatment of MTX and TwHF placebo Drug: Treatment of TwHF and MTX placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||264 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of Tripterygium Wilfordii Treating Rheumatoid Arthritis and Establish A Prediction Model|
|Actual Study Start Date :||October 28, 2017|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Active Comparator: Treatment of MTX and TwHF placebo
Patients were treated with Methotrexate (MTX) and Tripterygium wilfordii Hook F（TwHF）placebo.
Drug: Treatment of MTX and TwHF placebo
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.
Experimental: Treatment of TwHF and MTX placebo
Patients were treated with Tripterygium wilfordii Hook F（TwHF）and Methotrexate (MTX) placebo.
Drug: Treatment of TwHF and MTX placebo
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.
- The change in Disease Activity Score (DAS28) [ Time Frame: 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks ]Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4[ESR])
- The proportion of patients achieving ACR20/50/70 [ Time Frame: 0 weeks, 4 weeks，12 weeks, 24 weeks ]ACR20/50/70 is referred to American College of Rheumatology Criteria
- The change in Health Assessment Questionnaire (HAQ) score [ Time Frame: 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks ]HAQ scores ranges from 0 to 3, with higher scores indicating greater disability
- The change in Sharp scoring system of van der Heijde(Sharp) score [ Time Frame: 0 week,24 weeks,52 weeks ]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.
- The number of adverse events [ Time Frame: 24 weeks ]The number of adverse events that are related to treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337815
|Contact: Jiang Quan, MDfirstname.lastname@example.org|
|Beijing, Beijing, China, 100053|
|Contact: Quan Jiang +8688001060 email@example.com|
|Study Director:||Jiang Quan, MD||Guang'anmen Hospital of China Academy of Chinese Medical Sciences|