A Study to Assess Efficacy and Safety of Wangbi Capsule in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Assess Efficacy and Safety of Wangbi Capsule in Patients With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a diagnosis of RA as defined by the ACR/EULAR 2010 classification criteria Patients older than 18 Syndrome of insufficiency of liver and kidney or syndrome of cold and dampness defined by traditional Chinese medicine Exclusion Criteria: Patients who are pregnant or breast feeding at enrolment History of malignancy prior to screening Patients with severe or poorly controlled chronic diseases such as hypertension, diabetes and coronary heart disease Patients taking biological agents, > 10mg prednisone (or equivalent amount of other glucocorticoids) ，more than 2 kinds of DMARDs or similar TCM drug like Wangbi Capsule

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Wangbi Capsule<br>Patients who are taking Wangbi Capsule for the treatment. | |
| Other drugs<br>Patients who are not taking Wangbi Capsule for the treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 |