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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 March 2022 |
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Main ID: |
NCT04136262 |
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Date of registration:
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21/10/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis
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Scientific title:
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Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis: a Randomized Controlled Trial |
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Date of first enrolment:
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November 25, 2019 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04136262 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Quan Jiang, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Quan Jiang, M.D |
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Address:
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Telephone:
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+8613901081632 |
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Email:
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doctorjq@126.com |
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Affiliation:
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Name:
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Quan Jiang, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Guang' anmen hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Methotrexate
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Other: Dummy Tripterygium wilfordii Hook F (TwHF)
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Drug: Tripterygium wilfordii Hook F (TwHF)
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Primary Outcome(s)
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Percentage of ACR20
[Time Frame: week 24]
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Secondary Outcome(s)
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Percentage of ACR50
[Time Frame: week 24]
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RAMRIS score
[Time Frame: week 24]
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Patient Reported Outcomes (PRO)
[Time Frame: week 24]
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Change From Baseline in Modified Total Sharp X-Ray Score at Week 24
[Time Frame: week 24]
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Mean 24-week Change in Disease Activity Score Based on 28-Joint Count (DAS28)
[Time Frame: week 24]
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Percentage of ACR70
[Time Frame: week 24]
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Secondary ID(s)
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2018YFC1705204
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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