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

• Status: Recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

1. 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;

2. diagnosed with RA as determined by meeting the 2010 ACR/EULAR classification criteria and having had RA for at least 6 weeks;

3. active disease at the time of enrollment as indicated by 28-joint Disease Activity Score (DAS28) greater than 3.2;

4. no prior exposure to oral glucocorticoids at a daily dose greater than 10 mg or to any biologic agents.

Exclusion Criteria:

1. RA combined with other autoimmune disease, such as adjuvant arthritis, lupus arthritis, or osteoarthritis;

2. RA combined with abnormal liver and kidney function;

3. severe chronic or acute disease interfering with attendance for therapy;

4. patients who had received DMARDs or biological therapy within one months before participating in this study.