Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis

Browse trials for

• Arthritis 3,554
• Arthritis, Rheumatoid 2,888

Keywords

• Rheumatoid Arthritis
• Methotrexate
• Tripterygium

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 201 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Study arms

• Placebo comparator
  Methotrexate

  Patients were treated with methotrexate alone.

  Drug: Methotrexate

• Experimental
  T2

  Patients were treated with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).

  Drug: Tripterygium wilfordii Hook F

• Experimental
  MTX+T2

  The patients were treated with methotrexate and T2.

  Drug: Tripterygium wilfordii Hook F · Drug: Methotrexate

Interventions

• DrugTripterygium wilfordii Hook F

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

• DrugMethotrexate

  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.

Primary outcomes

1. ACR50

   The proportion of patients achieving ACR50.

   Time frame: 24 weeks.

Secondary outcomes

1. Radiology outcome

   The change in X-Ray from baseline to week 24.

   Time frame: 24 weeks

2. DAS28

   The change in DAS score from baseline to week 24.

   Time frame: 24 weeks

3. ACR20/70

   The proportion of patients achieving ACR20 \& ACR70.

   Time frame: 24 weeks

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. PubMed 29636089 ↗
• 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. PubMed 24733191 ↗