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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Arthritis, Rheumatoid	Drug: Tripterygium wilfordii Hook F; Drug: Methotrexate	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 201 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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.
• Study Start Date: May 2012
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: June 2013

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. ACR50 [ Time Frame: 24 weeks. ]
   The proportion of patients achieving ACR50.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

China, Beijing

Deptment of Rheumatology, Peking Union Medical College Hospital

Beijing, Beijing, China, 100032

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Xuan Zhang, Professor, Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT01613079
• Other Study ID Numbers: TRIFRA
• First Posted: June 6, 2012
• Last Update Posted: August 5, 2013
• Last Verified: August 2013

Keywords provided by Xuan Zhang, 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; 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