Clinical trial NCT05219214: China Rheumatoid Arthritis Registry of Patients With Chinese Medicine
Official title: China Rheumatoid Arthritis Registry of Patients With Chinese Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who meet the criteria will be enrolled from multi-centers in China.

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Refuse informed consent.

Primary outcomes:
measure: 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
timeFrame: Month 12
Secondary outcomes:
measure: Change From Baseline in DAS28(CRP) at Month 12
timeFrame: Baseline and month 12
measure: 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
timeFrame: Month 12
measure: Change From Baseline in DAS28(ESR) at Month 12
timeFrame: Baseline and month 12
measure: Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points
timeFrame: through study completion, once every three months
measure: Percentage of Participants Who Achieved DAS28(ESR) Remission (DAS28 <2.6) at All Time Points
timeFrame: through study completion, once every three months
measure: Title:Change From Baseline in DAS28(CRP) at All Assessment Time Points
timeFrame: through study completion, once every three months
measure: Title:Change From Baseline in DAS28(ESR) at All Assessment Time Points
timeFrame: through study completion, once every three months
measure: Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points
timeFrame: through study completion, once every three months
measure: Title:Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission at All Assessment Time Points
timeFrame: through study completion, once every three months
measure: Title:Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at All Assessment Time Points
timeFrame: through study completion, once every three months
measure: Change From Baseline in Chinese Patient-reported Activity Index with Rheumatoid Arthritis (CPRI-RA) at All Assessment Time Points
timeFrame: through study completion, once every three months
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at All Assessment Time Points
timeFrame: through study completion, once every three months
measure: Participants' sharp score or modified total Sharp score(mTSS) score of wrist bone destruction at All Assessment Time Points
timeFrame: through study completion, once every three months
measure: Number of Participants With Hematologic System Events at All Assessment Time Points
timeFrame: through study completion, once every three months
measure: Number of Participants With Metabolic Abnormal Events at All Assessment Time Points
timeFrame: through study completion, once every three months
measure: Number of Participants With Cardiac Events
timeFrame: Up to 24 months
measure: Number of Participants With Pulmonary Events
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Study officials:
References:
citation: 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.