Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Only males
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...
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.
Tracking Information
- NCT #
- NCT04136262
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Quan Jiang, M.D Guang' anmen hospital