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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tripterygium wilfordii Hook F (TwHF) plus methotrexate (MTX) | Experimental | Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks. |
|
| TwHF (dummy) plus MTX | Placebo Comparator | Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tripterygium wilfordii Hook F (TwHF) | Drug | Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of ACR20 | Percentage of Participants With American College of Rheumatology 20% (ACR20) | week 24 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quan Jiang, M.D | Contact | +8613901081632 | 0 | doctorjq@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Quan Jiang, M.D | Guang' anmen hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital, China Academy of Chinese Medical Sciences | Recruiting | Beijing | 100053 | China |
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|
| Methotrexate | Drug | Oral methotrexate 10 mg per week for 24 weeks. |
|
|
| Dummy Tripterygium wilfordii Hook F (TwHF) | Other | Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. |
|
| 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 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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