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This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate whether Colquhounia Root Tablet combined with methotrexate (MTX) might be better than MTX alone for patients with active rheumatoid arthritis (RA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colquhounia Root Tablet plus methotrexate (MTX) | Active Comparator | Colquhounia Root Tablet 0.9g tid and methotrexate (MTX) 10 mg oncea week for the first 12 weeks,Colquhounia Root Tablet 0.54g tid and methotrexate (MTX) 10 mg once a week for the after 12 weeks. |
|
| placedo of Colquhounia Root Tablet plus methotrexate (MTX) | Placebo Comparator | placedo of Colquhounia Root Tablet 0.9g tid and methotrexate (MTX) 10 mg oncea week for the first 12 weeks,placedo of Colquhounia Root Tablet 0.54g tid and methotrexate (MTX) 10 mg once a week for the after 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colquhounia Root Tablet | Drug | Colquhounia Root Tablet is a tripterygium preparation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of ACR20 | Percentage of Participants With American College of Rheumatology 20% (ACR20) | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of ACR50 | Percentage of Participants With American College of Rheumatology 50% (ACR50) | week 24 |
| Percentage of ACR70 | Percentage of Participants With American College of Rheumatology 70% (ACR70) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quan Jiang, M.D | Contact | +8613901081632 | doctorjq@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Beijing | Beijing Municipality | 100052 | China |
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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 tablets | Drug | Methotrexate is a drug used to treat rheumatoid arthritis |
|
| week 24 |
| DAS28-ESR | 28-joint disease activity score | week 24 |
| Chinese Patient-reported Activity Index with RA scale (PRO) | Patient-Reported Outcomes Scale,The self-rating scale consists of 12 items,Each item was rated 0, 1, 2 and 3 on the scale of asymptomatic to aggravating symptoms, respectively. | week 24 |
| 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 |