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Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis

NCT01613079 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2013-08-05

No results posted yet for this study

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.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

Tripterygium wilfordii Hook F

Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.

DRUG

Methotrexate

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Xuan Zhang, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01613079 on ClinicalTrials.gov