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

Browse trials for

• Arthritis 3,554
• Arthritis, Rheumatoid 2,888

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 155 across 1,057 observational studies indexed under Arthritis.

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 133 studies on the registry; 36 are open to participants now.

Study population

Groups and cohorts

• Wangbi Capsule

  Patients who are taking Wangbi Capsule for the treatment.

• Other drugs

  Patients who are not taking Wangbi Capsule for the treatment.

Primary outcomes

1. 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

   Time frame: Week 52

Secondary outcomes

1. 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).

   Time frame: Week 12, Week 24,Week 52

2. 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.

   Time frame: Baseline, Week 12, Week 24, Week 52

3. 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.

   Time frame: Baseline, Week 12, Week 24,Week 52

4. Change From Baseline in erythrocyte sedimentation rate(ESR)

   Change From Baseline in erythrocyte sedimentation rate at Week 12，24 and 52

   Time frame: Baseline, Week 12, Week 24,Week 52

5. Change From Baseline in C-reactive protein(CRP)

   Change From Baseline in C-reactive protein at Week 12，24 and 52

   Time frame: Baseline, Week 12, Week 24,Week 52

6. 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

   Time frame: Week 12, Week 24