China Rheumatoid Arthritis Registry of Patients With Chinese Medicine

NCT05219214 | Unknown

• 1 other identifier: Guang'anmen
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief Summary

A multi-center registration study of clinical characteristics of rheumatoid arthritis (RA) patients with Chinese medicine.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Disease Activity Score for 28 Different Joints With C-reactive Protein Value (DAS28{CRP}) Remission (DAS28 <2.6) at Month 12

  DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56\*√(TJC28) +0.28\*√(SJC28)+0.014\*GH+0.36\*ln(CRP+1)+0.96. Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 millimeter \[mm\] visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in \[milligrams/liter\] mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome).

  Month 12

Secondary Outcomes (17)

• Change From Baseline in DAS28(CRP) at Month 12

  Baseline and month 12

• Percentage of Participants Who Achieved Disease Activity Score for 28 Different Joints With erythrocyte sedimentation rate (DAS28{ESR}) Remission (DAS28 <2.6) at Month 12

  Month 12

• Change From Baseline in DAS28(ESR) at Month 12

  Baseline and month 12

• Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points

  through study completion, once every three months

• Percentage of Participants Who Achieved DAS28(ESR) Remission (DAS28 <2.6) at All Time Points

  through study completion, once every three months

Study Arms (1)

Chinese medicine group

Other: Chinese medicine

Interventions

Chinese medicine OTHER

There are no restrictions on TCM therapy, including Chinese herbal medicine, Chinese patent medicine, external treatment, acupuncture and moxibustion, etc

Chinese medicine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who meet the criteria will be enrolled from multi-centers in China.

You may qualify if:

• Fulfilled the rheumatoid arthritis classification criteria of 2010 American College of Rheumatology (ACR)/the European League Against Rheumatism (EULAR) .
• Aged 18 years and older.
• Be willing to accept CM therapies defined as Chinese herbal medicine, Chinese patent medicine, external treatment, acupuncture and moxibustion, etc

You may not qualify if:

• Refuse informed consent.

Sponsors & Collaborators

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

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, 100053, China

RECRUITING

Related Publications (3)

• Ma XL, Xia CM, Chang T, Liu ZX, Yang YC, Yao CH, Liu WX, Gong X, Jiang Q. Effectiveness and Safety of Biqi Capsules in 2,267 Patients with Rheumatoid Arthritis: A Real-World Clinical Study. Chin J Integr Med. 2026 Jan 15. doi: 10.1007/s11655-026-4137-5. Online ahead of print.

  PMID: 41540164 DERIVED

• Yao CH, Zhang C, Song MG, Xia CM, Chang T, Ma XL, Liu WX, Liu ZX, Liu JM, Tang XP, Liu Y, Liu J, Peng JY, He DY, Huang QC, Gao ML, Yu JP, Liu W, Zhang JY, Zhu YL, Hou XJ, Wang HD, Fang YF, Wang Y, Su Y, Tian XP, Lyu AP, Gong X, Jiang Q. Glucocorticoid Discontinuation in Patients with Rheumatoid Arthritis under Background of Chinese Medicine: Challenges and Potentials Coexist. Chin J Integr Med. 2025 Jul;31(7):581-589. doi: 10.1007/s11655-025-4212-3. Epub 2025 Jun 24.

  PMID: 40553362 DERIVED

• Gong X, Liu WX, Li D, Peng QW, Xia CM, Chang T, Guan JZ, Song MG, Zhang FY, Tang XP, Liu Y, Liu J, Peng JY, He DY, Huang QC, Gao ML, Yu JP, Liu W, Zhang JY, Zhu YL, Hou XJ, Wang HD, Fang YF, Wang Y, Su Y, Tian XP, Su X, Meng QL, Wen SY, Wang B, Li ZG, Liu J, Jiang H, Hu Y, Li HL, Wei SF, Zhu WH, Lyu AP, Zhang C, Jiang Q; CERTAIN Group. China rheumatoid arthritis registry of patients with Chinese medicine (CERTAIN): Rationale, design, and baseline characteristics of the first 11,764 enrollees. Phytomedicine. 2022 Sep;104:154236. doi: 10.1016/j.phymed.2022.154236. Epub 2022 Jun 14.

  PMID: 35797864 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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: January 1, 2022
• First Posted: February 2, 2022
• Study Start: September 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

CN (1)