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Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis (TRIFRA)

This study is currently recruiting participants.
Verified June 2012 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Xuan Zhang, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01613079
First received: June 4, 2012
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Arthritis, Rheumatoid
 Drug: Tripterygium wilfordii Hook F
Drug: Methotrexate
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • ACR50 [ Time Frame: 24 weeks. ] [ Designated as safety issue: No ]
    The proportion of patients achieving ACR50.


Secondary Outcome Measures:
  • Radiology outcome [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The change in X-Ray from baseline to week 24.

  • DAS28 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The change in DAS score from baseline to week 24.

  • ACR20/70 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The proportion of patients achieving ACR20 & ACR70.


Estimated Enrollment: 210
Study Start Date: May 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Methotrexate
Patients were treated with methotrexate alone.
 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.
Experimental: T2
Patients were treated with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).
 Drug: Tripterygium wilfordii Hook F
Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.
Experimental: MTX+T2
The patients were treated with methotrexate and T2.
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613079

Contacts
Contact: Xuan Zhang, MD +861069158795 zxpumch2003@yahoo.com.cn

Locations
China, Beijing
Deptment of Rheumatology, Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100032
Contact: Xuan Zhang, MD     861069158795     zxpumch2003@yahoo.com.cn    
Principal Investigator: Xuan Zhang, MD            
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Xuan Zhang, MD Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Xuan Zhang, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01613079     History of Changes
Other Study ID Numbers: TRIFRA
Study First Received: June 4, 2012
Last Updated: June 7, 2012
Health Authority: China: National Natural Science Foundation

Keywords provided by Peking Union Medical College Hospital:
Rheumatoid Arthritis
Methotrexate
Tripterygium

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013