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Evaluation of oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of RA patients with clinical efficacy and safety.Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate | Placebo Comparator | Patients were treated with methotrexate alone. |
|
| T2 | Experimental | Patients were treated with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F). |
|
| MTX+T2 | Experimental | The patients were treated with methotrexate and T2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tripterygium wilfordii Hook F | Drug | Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ACR50 | The proportion of patients achieving ACR50. | 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiology outcome | The change in X-Ray from baseline to week 24. | 24 weeks |
| DAS28 | The change in DAS score from baseline to week 24. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xuan Zhang, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deptment of Rheumatology, Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29636089 | Derived | Zhou YZ, Zhao LD, Chen H, Zhang Y, Wang DF, Huang LF, Lv QW, Liu B, Li Z, Wei W, Li H, Liao X, Liu H, Liu X, Jin H, Wang J, Fei YY, Wu QJ, Zhang W, Shi Q, Zheng WJ, Zhang FC, Tang FL, Lipsky PE, Zhang X. Comparison of the impact of Tripterygium wilfordii Hook F and Methotrexate treatment on radiological progression in active rheumatoid arthritis: 2-year follow up of a randomized, non-blinded, controlled study. Arthritis Res Ther. 2018 Apr 10;20(1):70. doi: 10.1186/s13075-018-1563-6. | |
| 24733191 |
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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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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Methotrexate | Drug | Oral methotrexate 7.5-12.5mg per week for 24 weeks. The starting dose was 7.5mg per week, then increased to 12.5mg（max 0.3mg/Kg） per week in 4 weeks. Folic acid at the dose of 10mg per week were applied to all patients. |
|
| 24 weeks |
| ACR20/70 | The proportion of patients achieving ACR20 & ACR70. | 24 weeks |
| Derived |
| Lv QW, Zhang W, Shi Q, Zheng WJ, Li X, Chen H, Wu QJ, Jiang WL, Li HB, Gong L, Wei W, Liu H, Liu AJ, Jin HT, Wang JX, Liu XM, Li ZB, Liu B, Shen M, Wang Q, Wu XN, Liang D, Yin YF, Fei YY, Su JM, Zhao LD, Jiang Y, Li J, Tang FL, Zhang FC, Lipsky PE, Zhang X. Comparison of Tripterygium wilfordii Hook F with methotrexate in the treatment of active rheumatoid arthritis (TRIFRA): a randomised, controlled clinical trial. Ann Rheum Dis. 2015 Jun;74(6):1078-86. doi: 10.1136/annrheumdis-2013-204807. Epub 2014 Apr 14. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |