Clinical trial NCT05393050: Efficacy and Safety of Colquhounia Root Tablet in Patients With Rheumatoid Arthritis
Official title: Efficacy and Safety of Colquhounia Root Tablet in Patients With Rheumatoid Arthritis：A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Colquhounia Root Tablet
Methotrexate
Randomized controlled trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of ACR20
timeFrame: week 24
Secondary outcomes:
measure: Percentage of ACR50
timeFrame: week 24
measure: Percentage of ACR70
timeFrame: week 24
measure: DAS28-ESR
timeFrame: week 24
measure: Chinese Patient-reported Activity Index with RA scale (PRO)
timeFrame: week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
References: