Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis

NCT05540938 | Recruiting Phase 4

• 1 other identifier: 2022-NHLHCRF-LX-02-02
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

The group used a randomized controlled trial to conduct a post-marketing re-evaluation study of Wangbi granules. The study was conducted to observe the degree of clinical remission in rheumatoid arthritis patients with low disease activity after standard methotrexate and tofacitinib citrate treatment, using a combination of Chinese and Western medicine treatment with Wangbi granules. The study aims to provide evidence-based medical evidence to improve the clinical efficacy of rheumatoid arthritis, enhance the depth of remission, and improve the diagnosis and treatment of rheumatoid arthritis.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• DAS28

  Disease mobility score for 28 joints, higher scores indicate higher disease activity

  12 weeks

Secondary Outcomes (2)

• Fatigue Scale-14

  12 weeks

• visual analogue scale

  12 weeks

Study Arms (2)

treatment group

EXPERIMENTAL

Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months.

Drug: Wangbi granules

control group

ACTIVE COMPARATOR

Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months.

Drug: Wangbi granules simulant

Interventions

Wangbi granules DRUG

Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months.

treatment group

Wangbi granules simulant DRUG

Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months.

control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years.
• Meeting the 1987 ACR or 2010 ACR/EULAR diagnostic criteria.
• Meeting the diagnostic criteria of Chinese medicine for Kidney deficiency and dampness and stasis blocking channels in Chinese medicine.
• Rheumatoid arthritis disease activity score DAS28 of 2.6 to 3.2.
• Regularly taking methotrexate 7.5-15 mg qw and tofacitab 5 mg bid before enrollment and stable treatment regimen for more than 4 weeks.
• Voluntary participation and signed written informed consent.

You may not qualify if:

• Patients taking immunosuppressive drugs other than traditional DMARDs for rheumatoid arthritis within 3 months prior to enrollment (traditional DMARDs include hydroxychloroquine sulfate, methotrexate, salazosulfapyridine tablets, and raglan polysaccharide tablets, among others).
• Organ transplant recipients, patients with malignant tumors, patients with heart, brain, liver (ALT/AST \> 3 times the normal upper limit), kidney (Ccr \<60ml/min) and other important organ function impairment or hematological system diseases.
• Psychiatric disorders such as cognitive disorders, depression, anxiety disorders, somatic dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating lesions and other central neurological disorders, or peripheral neurological disorders such as restless legs syndrome. peripheral neurological disorders such as restless legs syndrome.
• Women and men who are pregnant or breastfeeding or who are planning a pregnancy within the next 6 months; during the trial or within 1 month of the last dose Women of childbearing age who are unable or unwilling to use adequate contraception, or whose spouse is unwilling to use contraception, within one month of the last dose or within one month of the last dose are unwilling to use contraception.
• Persons with a BMI greater than 35 (kg/m2), allergic to the test drug, or participating in other clinical trials.
• Other conditions deemed by the investigator to be inappropriate for trial participation (out-of-town patients unable to be followed up, etc.).

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead
• Peking Union Medical College Hospital: collaborator
• The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine: collaborator
• The 980th Hospital of PLA Joint Logistics Support Force: collaborator
• The Second Affiliated Hospital of Zhejiang Chinese Medical University: collaborator
• Southwest Hospital, China: collaborator

Study Sites (1)

China-Japan Friendship Hospital

Beijing, 100029, China

RECRUITING

Related Publications (1)

• Wang J, Wang Z, Lan T, Zhang L, Li Z, Wang X, Zou Q, Wang Y, Li Y, Luo R, Zhang N, Xu Y, Li M, Tao Q. Wangbi granule as a combination therapy to achieve clinical deep remission in rheumatoid arthritis: protocol for a multicenter, triple-blind, randomised, placebo-controlled trial. Chin Med. 2023 Feb 28;18(1):22. doi: 10.1186/s13020-023-00728-6.

  PMID: 36855169 DERIVED

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

Central Study Contacts

Zihan Wang, Dr

CONTACT

+8618810902100; wzhbucm@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2022
• First Posted: September 15, 2022
• Study Start: May 23, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)