A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of Tripterygium Wilfordii Treating Rheumatoid Arthritis and Establish A Prediction Model
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 264
- Locations
- 1
- Primary Endpoint
- The change in Disease Activity Score (DAS28)
Study 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: 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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 and TwHF placebo
Patients were treated with Methotrexate (MTX) and Tripterygium wilfordii Hook F（TwHF）placebo.
Intervention: Treatment of MTX and TwHF placebo (Drug)
Treatment of TwHF and MTX placebo
Patients were treated with Tripterygium wilfordii Hook F（TwHF）and Methotrexate (MTX) placebo.
Intervention: Treatment of TwHF and MTX placebo (Drug)
Outcomes
Primary Outcomes
The change 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 scoring system of van der Heijde(Sharp) score(0 week,24 weeks,52 weeks)
- The number of adverse events(24 weeks)
Investigators
Quan Jiang
director
Guang'anmen Hospital of China Academy of Chinese Medical Sciences