Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Colquhounia Root Tablet, Methotrexate, Randomized controlled trial
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).
Interventions
DRUGColquhounia Root Tablet
Colquhounia Root Tablet is a tripterygium preparation
Methotrexate is a drug used to treat rheumatoid arthritis
Sponsors
Quan Jiang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of ACR20 | week 24 | Percentage of Participants With American College of Rheumatology 20% (ACR20) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of ACR50 | week 24 | Percentage of Participants With American College of Rheumatology 50% (ACR50) |
| Percentage of ACR70 | week 24 | Percentage of Participants With American College of Rheumatology 70% (ACR70) |
| DAS28-ESR | week 24 | 28-joint disease activity score |
| Chinese Patient-reported Activity Index with RA scale (PRO) | week 24 | 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. |
Countries
China
Contacts
Primary ContactQuan Jiang, M.D
Outcome results
None listed