Status:
UNKNOWN
Efficacy and Safety of TwHF and MTX in Patients With Rheumatoid Arthritis
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
45-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tr...
Detailed Description
Two arms were included in this study. Active Comparator: treatment of MTX Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.Experimental: treatment of TwHF Pa...
Eligibility Criteria
Inclusion
- Diagnosed with rheumatoid arthritis as determined by the 1987 or 2010 ACR classification criteria;
- No male or female fertility requirements, or around menopause women;
- Patients with mild-to-moderate activity, 2.6 \< DAS28≤5.1;
- No serious system involved, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, atrophic gastritis, autoimmune liver disease, etc;
- Within a month before the selected participants did not attend any drugs
Exclusion
- Patients with cancer or other malignant disease such as cardiovascular, hematopoietic, liver and kidney disease, and psychopath
- Active or chronic infection, including HIV, hepatitis C virus, hepatitis B virus, tuberculosis
- Previous treated with tripterygii, glucocorticoid or biologic disease-modifying antirheumatic drug (DMARD) in 3 months.
- Previous treated with Tripterygium Wilfordii or MTX
- Patients with retinopathy.
Key Trial Info
Start Date :
October 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2019
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT03324412
Start Date
October 28 2017
End Date
September 30 2019
Last Update
October 27 2017
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