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

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ClinicalTrials.gov Identifier: NCT04652791
Recruitment Status : Not yet recruiting
First Posted : December 3, 2020
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Description
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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.

Condition or disease
Rheumatoid Arthritis

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 52 Weeks
Official Title: A Study to Assess Efficacy and Safety of Wangbi Capsule in Patients With Rheumatoid Arthritis
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Wangbi Capsule
Patients who are taking Wangbi Capsule for the treatment.
Other drugs
Patients who are not taking Wangbi Capsule for the treatment.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving Disease Activity Score 28（DAS 28）≤3.2 [ Time Frame: Week 52 ]
    Percentage of Participants achieving Disease Activity Score 28（DAS 28）≤3.2 at week 52


Secondary Outcome Measures :
  1. Percentage of Participants Achieving American College of Rheumatology Response 20/50/70 [ Time Frame: 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).

  2. Change from baseline in Disease Activity Score Based on 28-Joint Count (DAS28) [ Time Frame: 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.

  3. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: 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.

  4. Change From Baseline in erythrocyte sedimentation rate(ESR) [ Time Frame: Baseline, Week 12, Week 24,Week 52 ]
    Change From Baseline in erythrocyte sedimentation rate at Week 12，24 and 52

  5. Change From Baseline in C-reactive protein(CRP) [ Time Frame: Baseline, Week 12, Week 24,Week 52 ]
    Change From Baseline in C-reactive protein at Week 12，24 and 52

  6. Percentage of Participants Achieving Disease Activity Score 28≤3.2 [ Time Frame: Week 12, Week 24 ]
    Percentage of Participants achieving Disease Activity Score 28≤3.2 at week 12 and 24


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
RA
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652791


Locations
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China, Beijing
Guang'anmen Hospital
Beijing, Beijing, China, 100053
Contact: Quan Jiang, Doctor    86-010-88001132    doctorjq@126.com   
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
More Information
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Responsible Party: Quan Jiang, Director, Devision of Rheumatology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT04652791    
Other Study ID Numbers: 20201005V1
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases