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| Name | Class |
|---|---|
| Shanghai CP Guojian Pharmaceutical Co., Ltd. | INDUSTRY |
The purpose of this study is to evaluate whether etanercept combined with methotrexate are superiority than etanercept as monotherapy in the treatment of chinese severe plaque psoriasis. A phase IV, multicenter, randomized, double-blind, controlled trial was conducted.The primary outcome was Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI75 (a patient that has an improvement from baseline PASI of at least 75%)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etanercept combined with methotrexate | Experimental | patients treated with etanercept combined with methotrexate |
|
| etanercept as monotherapy | Experimental | patients treated with etanercept combined with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept combined with methotrexate or etanercept combined with placebo | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| psoriasis area and severity index 75(PASI75) | Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI75 (a patient that has an improvement from baseline PASI of at least 75%) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| psoriasis area and severity index 50(pasi 50) | Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI50 (a patient that has an improvement from baseline PASI of at least 50%) | 24 weeks |
| psoriasis area and severity index 90(pasi 90) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the 2Nd Affiliated Hospital,Zhejiang University, | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI90 (a patient that has an improvement from baseline PASI of at least 90%) |
| 24 weeks |
| Dermatology Life Quality Index (DLQI) change | Change from baseline in plaque psoriasis as assessed by DLQI (dermatology life quality index ) response | 24 weeks |
| adverse events(AEs) | Laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs | 24 weeks |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |