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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04652791
• Other study ID #: 20201005V1
• Status: Not yet recruiting
• Start date: December 2020
• Est. completion date: February 2022

Study information

• Verified date: December 2020
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
China	Guang'anmen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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