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This study is intended to evaluate the efficacy and safety of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in patients with active Rheumatoid Arthritis (RA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iguratimod and MTX combination | Experimental | Drug:Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid) Drug:MTX 2.5 mg/tablet, taken orally once a week, 4 tablets/week |
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| Leflunomide and MTX combination | Active Comparator | Drug: Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid) Drug: Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iguratimod | Drug | Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with ACR 20 response and Change in Disease Activity as measured by the DAS28 | week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in modified Total Sharp Score (mTSS) | week 52 | |
| Percentage of patients with ACR 50 response and ACR70 response | week 24,week 52 | |
| Change from baseline in number of swollen and tender joins, Erythrocyte sedimentation rate (ESR) ,C-reactive protein (CRP),anti-citrullinated-protein antibody (ACPA) and heumatoid factor(RF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| weihong zhao, doctor | Contact | +86(25) 8556 6666 | 8701 | zhaoweihong@simcere.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100032 | China |
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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 |
| D000077339 | Leflunomide |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Leflunomide | Drug | Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks |
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| Methotrexate | Drug | Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week,52 weeks |
|
| week 24, week 52 |
| Time to achieve the ACR20, ACR50 and ACR70 | week 12, week 24, week 40, week 52 |
| Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 and change from baseline in Health Assessment Questionnaire (HAQ) | week 12, week 24, week 40, week 52 |
| Incidence of adverse events | up to 52 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000630 |
| Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |