A Specification Clinical Application Research of Tripterygium Wilfordii Treating Rheumatoid Arthritis

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Treatment of MTX and TwHF placebo
* Drug: Treatment of TwHF and MTX placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment of MTX and TwHF placebo<br>Patients were treated with Methotrexate (MTX) and Tripterygium wilfordii Hook F（TwHF）placebo. | Drug: Treatment of MTX and TwHF placebo<br>* Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks.Tripterygium wilfordii Hook F（TwHF）placebo：20mg,3 times a day, oral, for 24 weeks.<br>|
| Experimental: Treatment of TwHF and MTX placebo<br>Patients were treated with Tripterygium wilfordii Hook F（TwHF）and Methotrexate (MTX) placebo. | Drug: Treatment of TwHF and MTX placebo<br>* Tripterygium wilfordii Hook F（TwHF)：20mg,3 times a day, oral, for 24 weeks.Methotrexate (MTX)placebo: 10-15mg per week according to patient's weight, oral, for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Disease Activity Score (DAS28) | Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4[ESR]) | 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients achieving ACR20/50/70 | ACR20/50/70 is referred to American College of Rheumatology Criteria | 0 weeks, 4 weeks，12 weeks, 24 weeks | 
| The change in Health Assessment Questionnaire (HAQ) score | HAQ scores ranges from 0 to 3, with higher scores indicating greater disability | 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks | 
| The change in Sharp scoring system of van der Heijde(Sharp) score | 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. | 0 week,24 weeks,52 weeks | 
| The number of adverse events | The number of adverse events that are related to treatment | 24 weeks |