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

NCT04652791 | Unknown DMC

• 1 other identifier: 20201005V1
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

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

  Week 52

Secondary Outcomes (6)

• Percentage of Participants Achieving American College of Rheumatology Response 20/50/70

  Week 12, Week 24,Week 52

• Change from baseline in Disease Activity Score Based on 28-Joint Count (DAS28)

  Baseline, Week 12, Week 24, Week 52

• Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)

  Baseline, Week 12, Week 24,Week 52

• Change From Baseline in erythrocyte sedimentation rate(ESR)

  Baseline, Week 12, Week 24,Week 52

• Change From Baseline in C-reactive protein(CRP)

  Baseline, Week 12, Week 24,Week 52

Study Arms (2)

Wangbi Capsule

Patients who are taking Wangbi Capsule for the treatment.

Other drugs

Patients who are not taking Wangbi Capsule for the treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

RA

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 52 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Devision of Rheumatology

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: December 3, 2020
• Study Start: December 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: December 3, 2020

Record last verified: 2020-12

Locations

CN (1)