Rheumatoid Arthritis
Conditions
Keywords
rheumatoid arthritis, Tripterygium wilfordii Hook F, methotrexate, postmenopausal women, randomized controlled trial
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 (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.
Interventions
DRUGMethotrexate
Oral methotrexate 10 mg per week for 24 weeks.
OTHERDummy Tripterygium wilfordii Hook F (TwHF)
Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks.
DRUGTripterygium wilfordii Hook F (TwHF)
Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks.
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of ACR20 | week 24 | Percentage of Participants With American College of Rheumatology 20% (ACR20) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of ACR70 | week 24 | Percentage of Participants With American College of Rheumatology 70% (ACR 70) |
| RAMRIS score | week 24 | To explore the structural efficacy of Tripterygium wilfordii Hook F (TwHF) on synovitis, osteitis, and joint erosions as measured by MRI in postmenopausal women with active RA using the change in the RAMRIS score from Baseline to Week 24. |
| Percentage of ACR50 | week 24 | Percentage of Participants With American College of Rheumatology 50% (ACR 50) |
| Change From Baseline in Modified Total Sharp X-Ray Score at Week 24 | week 24 | Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease |
| Patient Reported Outcomes (PRO) | week 24 | Patient-Reported Outcomes Scale |
| Mean 24-week Change in Disease Activity Score Based on 28-Joint Count (DAS28) | week 24 | Average difference between 24-week and Baseline DAS28 |
Countries
China
Contacts
Primary ContactQuan Jiang, M.D
Outcome results
None listed