Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid Arthritis, Methotrexate, Tripterygium

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.

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.

2018-04-1047 citations

10.1186/s13075-018-1563-6

Comparison of Tripterygium wilfordii Hook F with methotrexate in the treatment of active rheumatoid arthritis (TRIFRA): a randomised, controlled clinical trial.

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.

2014-04-14164 citations

10.1136/annrheumdis-2013-204807

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
ACR50	24 weeks.	The proportion of patients achieving ACR50.

Secondary

Measure	Time frame	Description
Radiology outcome	24 weeks	The change in X-Ray from baseline to week 24.
DAS28	24 weeks	The change in DAS score from baseline to week 24.
ACR20/70	24 weeks	The proportion of patients achieving ACR20 & ACR70.

Countries

China

Outcome results

None listed