NCT04136262

Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis

Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis: a Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate whether Tripterygium wilfordii Hook F combined with methotrexate (MTX) might be better than MTX alone for postmenopausal women with active rheumatoid arthritis (RA).

Detailed description

To compare the efficacy and safety of Tripterygium wilfordii Hook F (TwHF) and methotrexate (MTX) for postmenopausal women with active rheumatoid arthritis (RA), a multicenter, randomized controlled trial will be conducted. Three hundred postmenopausal women with active RA will be randomly allocated (1:1) to treatment with TwHF 20mg thrice daily and MTX 10 mg once a week for 24 weeks, or MTX plus dummy TwHF. The primary outcome is the percentage of participants with American College of Rheumatology 20% at week 24.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Tripterygium wilfordii Hook F (TwHF)	Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks.
DRUG	Methotrexate	Oral methotrexate 10 mg per week for 24 weeks.
OTHER	Dummy Tripterygium wilfordii Hook F (TwHF)	Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks.

Timeline

• Start date: 2019-11-25
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2019-10-23
• Last updated: 2022-03-22

Locations

1 site across 1 country: China