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

• ClinicalTrials.gov Identifier: NCT01613079
• Recruitment Status: Completed
• First Posted: June 6, 2012
• Last Update Posted: August 5, 2013
• Sponsor: Peking Union Medical College Hospital
• Information provided by (Responsible Party): Xuan Zhang, Peking Union Medical College Hospital

Tracking Information

• First Submitted Date: June 4, 2012
• First Posted Date: June 6, 2012
• Last Update Posted Date: August 5, 2013
• Study Start Date: May 2012
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 4, 2012)

ACR50 [ Time Frame: 24 weeks. ]

The proportion of patients achieving ACR50.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 4, 2012)

• Radiology outcome [ Time Frame: 24 weeks ]
  The change in X-Ray from baseline to week 24.
• DAS28 [ Time Frame: 24 weeks ]
  The change in DAS score from baseline to week 24.
• ACR20/70 [ Time Frame: 24 weeks ]
  The proportion of patients achieving ACR20 & ACR70.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis
• 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.
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Arthritis, Rheumatoid

Intervention

• 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.

Study Arms

• Placebo Comparator: Methotrexate
  Patients were treated with methotrexate alone.
  Intervention: Drug: Methotrexate
• Experimental: T2
  Patients were treated with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).
  Intervention: Drug: Tripterygium wilfordii Hook F
• Experimental: MTX+T2
  The patients were treated with methotrexate and T2.
  Interventions:

  • Drug: Tripterygium wilfordii Hook F
  • Drug: Methotrexate

Publications *

• Zhou YZ, Zhao LD, Chen H, Zhang Y, Wang DF, Huang LF, Lv QW, Liu B, Li Z, Wei W, Li H, Liao X, Liu H, Liu X, Jin H, Wang J, Fei YY, Wu QJ, Zhang W, Shi Q, Zheng WJ, Zhang FC, Tang FL, Lipsky PE, Zhang X. Comparison of the impact of Tripterygium wilfordii Hook F and Methotrexate treatment on radiological progression in active rheumatoid arthritis: 2-year follow up of a randomized, non-blinded, controlled study. Arthritis Res Ther. 2018 Apr 10;20(1):70. doi: 10.1186/s13075-018-1563-6.
• Lv QW, Zhang W, Shi Q, Zheng WJ, Li X, Chen H, Wu QJ, Jiang WL, Li HB, Gong L, Wei W, Liu H, Liu AJ, Jin HT, Wang JX, Liu XM, Li ZB, Liu B, Shen M, Wang Q, Wu XN, Liang D, Yin YF, Fei YY, Su JM, Zhao LD, Jiang Y, Li J, Tang FL, Zhang FC, Lipsky PE, Zhang X. Comparison of Tripterygium wilfordii Hook F with methotrexate in the treatment of active rheumatoid arthritis (TRIFRA): a randomised, controlled clinical trial. Ann Rheum Dis. 2015 Jun;74(6):1078-86. doi: 10.1136/annrheumdis-2013-204807. Epub 2014 Apr 14.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 2, 2013): 201
• Original Estimated Enrollment (submitted: June 4, 2012): 210
• Actual Study Completion Date: June 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01613079
• Other Study ID Numbers: TRIFRA
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Xuan Zhang, Peking Union Medical College Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Peking Union Medical College Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Xuan Zhang, MD; Peking Union Medical College Hospital

• PRS Account: Peking Union Medical College Hospital
• Verification Date: August 2013