Status:
UNKNOWN
Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions:
Rheumatoid Arthritis
Eligibility:
FEMALE
Phase:
PHASE2
PHASE3
Brief 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 (...
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 t...
Eligibility Criteria
Inclusion
- postmenopausal women, postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy;
- diagnosed with RA as determined by meeting the 2010 ACR/EULAR classification criteria and having had RA for at least 6 weeks;
- active disease at the time of enrollment as indicated by 28-joint Disease Activity Score (DAS28) greater than 3.2;
- no prior exposure to oral glucocorticoids at a daily dose greater than 10 mg or to any biologic agents.
Exclusion
- RA combined with other autoimmune disease, such as adjuvant arthritis, lupus arthritis, or osteoarthritis;
- RA combined with abnormal liver and kidney function;
- severe chronic or acute disease interfering with attendance for therapy;
- patients who had received DMARDs or biological therapy within one months before participating in this study.
Key Trial Info
Start Date :
November 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04136262
Start Date
November 25 2019
End Date
December 1 2022
Last Update
March 22 2022
Active Locations (1)
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1
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, China, 100053