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The aim of this multi-center, prospective, non-interventional cohort study is to evaluate the efficacy and safety of Wangbi capsule for rheumatoid arthritis patients in the real-world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wangbi Capsule | Patients who are taking Wangbi Capsule for the treatment. | ||
| Other drugs | Patients who are not taking Wangbi Capsule for the treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Disease Activity Score 28（DAS 28）≤3.2 | Percentage of Participants achieving Disease Activity Score 28（DAS 28）≤3.2 at week 52 | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology Response 20/50/70 | ACR responders are participants with at least 20%, 50% and 70% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measures participants perceived degree of difficulty performing daily activities, acute phase reactant as measured by hsCRP, Patient's Assessment of Pain-Visual Analog Scale (Pain-VAS), Patient's Global Assessment of Disease Activity (PaGADA_VAS), and Physician's Global Assessment of Disease Activity (PhGADA_VAS). |
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Inclusion Criteria:
Exclusion Criteria:
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RA
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital | Beijing | Beijing Municipality | 100053 | 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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| Week 12, Week 24,Week 52 |
| Change from baseline in Disease Activity Score Based on 28-Joint Count (DAS28) | DAS28 consists of a composite score of the following variables: tender joint count out of 28 (TJC28), swollen joint count out of 28 (SJC28), hsCRP [milligrams per liter (mg/L)], and Patient's Global Assessment of Disease Activity (PaGADA_VAS) on a 0 to 100 millimeter (mm) VAS (0=very well to 100=very poor). A decrease in DAS28-CRP indicates an improvement in participant's condition. | Baseline, Week 12, Week 24, Week 52 |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) | The disability assessment component of the HAQ assesses a subjects level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. | Baseline, Week 12, Week 24,Week 52 |
| Change From Baseline in erythrocyte sedimentation rate(ESR) | Change From Baseline in erythrocyte sedimentation rate at Week 12，24 and 52 | Baseline, Week 12, Week 24,Week 52 |
| Change From Baseline in C-reactive protein(CRP) | Change From Baseline in C-reactive protein at Week 12，24 and 52 | Baseline, Week 12, Week 24,Week 52 |
| Percentage of Participants Achieving Disease Activity Score 28≤3.2 | Percentage of Participants achieving Disease Activity Score 28≤3.2 at week 12 and 24 | Week 12, Week 24 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |