A Specification Clinical Application Research of Tripterygium Wilfordii Treating Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: Treatment of MTX and TwHF placeboDrug: Treatment of TwHF and MTX placebo
- Registration Number
- NCT03337815
- 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: Patients were treated with Methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.Experimental:Patients were treated with Methotrexate (MTX) placebo and Tripterygium wilfordii Hook F（TwHF)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 264
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment of MTX and TwHF placebo Treatment of MTX and TwHF placebo Patients were treated with Methotrexate (MTX) and Tripterygium wilfordii Hook F（TwHF）placebo. Treatment of TwHF and MTX placebo Treatment of TwHF and MTX placebo Patients were treated with Tripterygium wilfordii Hook F（TwHF）and Methotrexate (MTX) placebo.
- Primary Outcome Measures
Name Time Method The change in Disease Activity Score (DAS28) 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 Outcome Measures
Name Time Method The proportion of patients achieving ACR20/50/70 0 weeks, 4 weeks，12 weeks, 24 weeks ACR20/50/70 is referred to American College of Rheumatology Criteria
The change in Health Assessment Questionnaire (HAQ) score 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks HAQ scores ranges from 0 to 3, with higher scores indicating greater disability
The change in Sharp scoring system of van der Heijde(Sharp) score 0 week,24 weeks,52 weeks The change in Sharp score from baseline to week 24 and 52.According to the revised Sharp scoring system of van der Heijde, the joint gap score was scored in 30 regions of the hands (score range 0-120 points), and the bone erosion score was conducted in 32 areas (score range 0-160).The higher the score, the more serious the joint destruction.
The number of adverse events 24 weeks The number of adverse events that are related to treatment
Trial Locations
- Locations (1)
Guang'anmen Hospital
🇨🇳Beijing, Beijing, China