Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: Tripterygium wilfordii Hook F; Drug: Methotrexate

• Registration Number: NCT01613079
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-02
• Last Update Posted: 2013-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T2	Tripterygium wilfordii Hook F	Patients were treated with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).
MTX+T2	Tripterygium wilfordii Hook F	The patients were treated with methotrexate and T2.
Methotrexate	Methotrexate	Patients were treated with methotrexate alone.
MTX+T2	Methotrexate	The patients were treated with methotrexate and T2.

Primary Outcome Measures

Name	Time	Method
ACR50	24 weeks.	The proportion of patients achieving ACR50.

Secondary Outcome Measures

Name	Time	Method
DAS28	24 weeks	The change in DAS score from baseline to week 24.
ACR20/70	24 weeks	The proportion of patients achieving ACR20 \& ACR70.
Radiology outcome	24 weeks	The change in X-Ray from baseline to week 24.

Trial Locations

Locations (1)

Deptment of Rheumatology, Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China