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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis: a Randomized Controlled Trial

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Tripterygium wilfordii Hook F (TwHF)
* Drug: Methotrexate
* Other: Dummy Tripterygium wilfordii Hook F (TwHF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tripterygium wilfordii Hook F (TwHF) plus methotrexate (MTX)<br>Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks. | Drug: Tripterygium wilfordii Hook F (TwHF)<br>* Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks.<br>* Other names: DND Pharm;Drug: Methotrexate<br>* Oral methotrexate 10 mg per week for 24 weeks.<br>* Other names: XINYI Pharm;|
| Placebo Comparator: TwHF (dummy) plus MTX<br>Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks. | Drug: Methotrexate<br>* Oral methotrexate 10 mg per week for 24 weeks.<br>* Other names: XINYI Pharm;Other: Dummy Tripterygium wilfordii Hook F (TwHF)<br>* Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of ACR20 | Percentage of Participants With American College of Rheumatology 20% (ACR20) | week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of ACR50 | Percentage of Participants With American College of Rheumatology 50% (ACR 50) | week 24 | 
| Percentage of ACR70 | Percentage of Participants With American College of Rheumatology 70% (ACR 70) | week 24 | 
| RAMRIS score | 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. | week 24 | 
| Mean 24-week Change in Disease Activity Score Based on 28-Joint Count (DAS28) | Average difference between 24-week and Baseline DAS28 | week 24 | 
| Change From Baseline in Modified Total Sharp X-Ray Score at Week 24 | Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease | week 24 | 
| Patient Reported Outcomes (PRO) | Patient-Reported Outcomes Scale | week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rheumatoid arthritis, Tripterygium wilfordii Hook F, methotrexate, postmenopausal women, randomized controlled trial