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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: 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment of MTX | Active Comparator | Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F(TwHF)placebo. |
|
| Treatment of MTX and TwHF | Experimental | Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F(TwHF). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment of MTX | 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 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]) | 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 |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Treatment of MTX and TwHF | Drug | 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. |
|
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 score | The change in X-Ray from baseline to week 24 and 52. | 0 week,24 weeks,52 weeks |
| The number of adverse events | The number of adverse events that are related to treatment | 24 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |