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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment of MTX and TwHF placebo | Active Comparator | Patients were treated with Methotrexate (MTX) and Tripterygium wilfordii Hook F(TwHF)placebo. |
|
| Treatment of TwHF and MTX placebo | Experimental | Patients were treated with Tripterygium wilfordii Hook F(TwHF)and Methotrexate (MTX) placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment of MTX and TwHF placebo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The change in Disease Activity Score (DAS28) | Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4[ESR]) | 0 weeks, 4 weeks,12 weeks, 24 weeks,52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients achieving ACR20/50/70 | ACR20/50/70 is referred to American College of Rheumatology Criteria | 0 weeks, 4 weeks,12 weeks, 24 weeks |
| The change in Health Assessment Questionnaire (HAQ) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Quan, MD | Contact | 010-88001060 | doctor@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiang Quan, MD | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| Treatment of TwHF and MTX placebo | Drug | 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. |
|
HAQ scores ranges from 0 to 3, with higher scores indicating greater disability
| 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. | 0 week,24 weeks,52 weeks |
| The number of adverse events | The number of adverse events that are related to treatment | 24 weeks |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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