Efficacy and Safety of TwHF and MTX in Patients With 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: 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).

Official Title
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A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of TwHF and MTX Treating Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

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


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<br>Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo. | Drug: Treatment of MTX<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 MTX and TwHF<br>Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF). | Drug: Treatment of MTX and TwHF<br>* Methotrexate : 10-15mg per week according to patient's weight, oral, for 24 weeks.Tripterygium wilfordii Hook F（TwHF）：20mg， 3 times a day, 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 from Baseline to week 24 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 score | The change in X-Ray from baseline to week 24 and 52. | 0 week,24 weeks,52 weeks | 
| The number of adverse events | The number of adverse events that are related to treatment | 24 weeks |