Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

— TRIFRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613079
• Other study ID #: TRIFRA
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 4, 2012
• Last updated: August 2, 2013
• Start date: May 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

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

Locations

Country	Name	City	State
China	Deptment of Rheumatology, Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR50	The proportion of patients achieving ACR50.	24 weeks.	No
Secondary	Radiology outcome	The change in X-Ray from baseline to week 24.	24 weeks	No
Secondary	DAS28	The change in DAS score from baseline to week 24.	24 weeks	No
Secondary	ACR20/70	The proportion of patients achieving ACR20 & ACR70.	24 weeks	No