Rheumatoid Arthritis
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Disease Activity Score 28（DAS 28）≤3.2 | Week 52 | Percentage of Participants achieving Disease Activity Score 28（DAS 28）≤3.2 at week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Disease Activity Score Based on 28-Joint Count (DAS28) | Baseline, Week 12, Week 24, Week 52 | 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. |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) | Baseline, Week 12, Week 24,Week 52 | 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. |
| Percentage of Participants Achieving American College of Rheumatology Response 20/50/70 | Week 12, Week 24,Week 52 | 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). |
| Change From Baseline in C-reactive protein(CRP) | Baseline, Week 12, Week 24,Week 52 | Change From Baseline in C-reactive protein at Week 12，24 and 52 |
| Percentage of Participants Achieving Disease Activity Score 28≤3.2 | Week 12, Week 24 | Percentage of Participants achieving Disease Activity Score 28≤3.2 at week 12 and 24 |
| Change From Baseline in erythrocyte sedimentation rate(ESR) | Baseline, Week 12, Week 24,Week 52 | Change From Baseline in erythrocyte sedimentation rate at Week 12，24 and 52 |
Countries
China
Outcome results
None listed