Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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Evaluation of oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of RA patients with clinical efficacy and safety.Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks.

Official Title
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Evaluation of Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of RA Patients With Clinical Efficacy and Safety.

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Drug: Tripterygium wilfordii Hook F
* Drug: Methotrexate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 years with informed consent Diagnosed with rheumatoid arthritis as determined by meeting the 2010 ACR/EULAR classification criteria and has had rheumatoid arthritis for at least 6 weeks Swollen joint (SJC)≥3 and tender joint count(TJC)≥5 ESR >28 mm/hr or C-reactive protein > 20 mg/L Exclusion Criteria: Pregnant, lactating or further fertility requirements Previous treated with methotrexate or biologic DMARD. Active or chronic infection, including HIV, HCV, HBV, tuberculosis Patient with cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Methotrexate<br>Patients were treated with methotrexate alone. | Drug: Methotrexate<br>* Oral methotrexate 7.5-12.5mg per week for 24 weeks. The starting dose was 7.5mg per week, then increased to 12.5mg（max 0.3mg/Kg） per week in 4 weeks. Folic acid at the dose of 10mg per week were applied to all patients.<br>|
| Experimental: T2<br>Patients were treated with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F). | Drug: Tripterygium wilfordii Hook F<br>* Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.<br>|
| Experimental: MTX+T2<br>The patients were treated with methotrexate and T2. | Drug: Tripterygium wilfordii Hook F<br>* Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.<br>Drug: Methotrexate<br>* Oral methotrexate 7.5-12.5mg per week for 24 weeks. The starting dose was 7.5mg per week, then increased to 12.5mg（max 0.3mg/Kg） per week in 4 weeks. Folic acid at the dose of 10mg per week were applied to all patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR50 | The proportion of patients achieving ACR50. | 24 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiology outcome | The change in X-Ray from baseline to week 24. | 24 weeks | 
| DAS28 | The change in DAS score from baseline to week 24. | 24 weeks | 
| ACR20/70 | The proportion of patients achieving ACR20 & ACR70. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Methotrexate, Tripterygium