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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05393050
Other study ID # 2022-001P6A01
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date July 2022
Est. completion date June 2024

Study information

Verified date July 2022
Source Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Contact Quan Jiang, M.D
Phone +8613901081632
Email doctorjq@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate whether Colquhounia Root Tablet combined with methotrexate (MTX) might be better than MTX alone for patients with active rheumatoid arthritis (RA).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date June 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 45 Years to 70 Years
Eligibility Inclusion Criteria: 1. Subject understood the whole process of the trial and signed the informed consent voluntarily. 2. Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria. 3. Subjects aged between 45-70years who were the males without fertility requirements or menopausal women. 4. Subject has a DAS28 CRP disease activity score greater than 2.6 and less than 5.1. 5. Subject did not participate in any drug trials within 1 month before enrollment. Exclusion Criteria: 1. Pregnant women, women planning to become pregnant or breastfeeding. 2. Severe systemic involvement, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, autoimmune liver disease. 3. Active liver disease or abnormal liver function, ALT and AST are more than 1.5 times the upper limit of normal. 4. Renal impairment, serum creatinine greater than the upper limit of normal. 5. Bone marrow hematopoietic dysfunction, peripheral blood leukocytes <3.0×109/L, or definite anemia (hemoglobin less than 80g/L), or platelets <80×109/L, or other blood system diseases. 6. Active gastric and duodenal ulcers. 7. Uncontrolled severe hypertension, metabolic diseases. 8. malignant tumors. 9. Acute and/or chronic infectious diseases. 10. Severe cardiac arrhythmia found on electrocardiogram. 11. Mental illness, history of alcoholism, drug or other substance abuse. 12. Diagnosed with other connective tissue disease. 13. Those who have used immunosuppressants, biological agents, Colquhounia Root Tablet or drugs containing Tripterygium wilfordii within 1 month before enrollment. 14. Those who have previously used methotrexate or preparations containing tripterygium wilfordii for 12 weeks or more ,but their condition is not under control. 15. Adverse reactions have occurred in the past using Colquhounia Root Tablet or drugs containing Tripterygium wilfordii.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Colquhounia Root Tablet
Colquhounia Root Tablet is a tripterygium preparation
Methotrexate tablets
Methotrexate is a drug used to treat rheumatoid arthritis

Locations

Country Name City State
China Guang'anmen Hospital of China Academy of Chinese Medical Sciences Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Quan Jiang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of ACR20 Percentage of Participants With American College of Rheumatology 20% (ACR20) week 24
Secondary Percentage of ACR50 Percentage of Participants With American College of Rheumatology 50% (ACR50) week 24
Secondary Percentage of ACR70 Percentage of Participants With American College of Rheumatology 70% (ACR70) week 24
Secondary DAS28-ESR 28-joint disease activity score week 24
Secondary Chinese Patient-reported Activity Index with RA scale (PRO) Patient-Reported Outcomes Scale,The self-rating scale consists of 12 items,Each item was rated 0, 1, 2 and 3 on the scale of asymptomatic to aggravating symptoms, respectively. week 24
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