A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of TwHF and MTX Treating Rheumatoid Arthritis
Overview
- Phase
- Phase 2
- Intervention
- Treatment of MTX
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Enrollment
- 216
- Primary Endpoint
- The change from Baseline to week 24 in Disease Activity Score (DAS28)
- Last Updated
- 8 years ago
Overview
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 Tripterygium Wilfordii has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a multicenter ,double Blind, randomized study to evaluated the efficacy and safety of Tripterygium Wilfordii in treating of patients with rheumatoid arthritis (RA) and establish a prediction model for Tripterygium Wilfordii response of rheumatoid arthritis (RA).
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 Patients were treated with methotrexate (MTX) and Tripterygium wilfordii Hook F（TwHF).
Investigators
Quan Jiang
director
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Treatment of MTX
Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.
Intervention: Treatment of MTX
Treatment of MTX and TwHF
Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF).
Intervention: Treatment of MTX and TwHF
Outcomes
Primary Outcomes
The change from Baseline to week 24 in Disease Activity Score (DAS28)
Time Frame: 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks
Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4\[ESR\])
Secondary Outcomes
- The proportion of patients achieving ACR20/50/70(0 weeks, 4 weeks，12 weeks, 24 weeks)
- The change in Health Assessment Questionnaire (HAQ) score(0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks)
- The change in Sharp score(0 week,24 weeks,52 weeks)
- The number of adverse events(24 weeks)