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This study is intended to evaluate the safety and efficacy of Iguratimod in patients with active Rheumatoid Arthritis.
This is a multi-center, open, single arm study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iguratimod | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iguratimod | Drug | taken orally, 2 tablets/day (bid) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20) | week 24 | |
| Incidence of adverse events | up to 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients meeting the American College of Rheumatology 50% response criteria (ACR50) | week 24 | |
| Percentage of patients meeting the American College of Rheumatology 70% response criteria (ACR70) | week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhanguo Li, MD/PhD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34327344 | Derived | Mu R, Li C, Li X, Ke Y, Zhao L, Chen L, Wu R, Wu Z, Zuo X, Xie Y, Chen J, Wei W, Liu Y, Li Z, Dai L, Sun L, Liu X, Li Z. Effectiveness and safety of iguratimod treatment in patients with active rheumatoid arthritis in Chinese: A nationwide, prospective real-world study. Lancet Reg Health West Pac. 2021 Mar 22;10:100128. doi: 10.1016/j.lanwpc.2021.100128. eCollection 2021 May. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C519076 | iguratimod |
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| Change from baseline in Disease Activity Score 28 (DAS28) | week 24 |
| Change from baseline in Health Assessment Questionnaire (HAQ) | week 24 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |