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| Name | Class |
|---|---|
| China-Japan Friendship Hospital | OTHER |
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This is a multicenter, one-arm, prospective, observational study,intended to assess evaluation of efficacy and safety of Apremilast in Chinese patients with moderate-to-severe plaque psoriasis。During this study, it is expected to collect data at at baseline and weeks 2, 6, 10, 16, and 20 after treatment。
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apremilast | Dosage of Apremilast(Otezla®) from 10mg qd, titrate to recommended dosage of 30 mg BID,recommended by specification. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | Dosage of Apremilast(Otezla®) from 10mg qd, titrate to recommended dosage of 30 mg BID,recommended by specification. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLQI or PASI improvement | At week 16,Proportion of patients with DLQI improvement (DLQI ≤5 or DLQI improvement by ≥4 points from baseline) or PASI improvement (PASI <3) | 16 week |
| Measure | Description | Time Frame |
|---|---|---|
| PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS | Absolute values of change from baseline in PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS in subjects at week 16 of treatment | 16 week |
| DLQI improvement |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese patients with moderate to severe plaque psoriasis
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| Name | Affiliation | Role |
|---|---|---|
| Xinghua Gao, MD | First Hospital of China Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hospital of China Medical University | Shenyang | China | 110001 | China | ||
| China-Japan Friendship Hospital |
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Proportion of patients with DLQI score ≤5 or improvement ≥4 points from baseline at each visits
| 2 week |
| DLQI improvement | Proportion of patients with DLQI score ≤5 or improvement ≥4 points from baseline at each visits | 6 week |
| DLQI improvement | Proportion of patients with DLQI score ≤5 or improvement ≥4 points from baseline at each visits | 10 week |
| Beijing |
| China |
| 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 |
|---|---|
| C505730 | apremilast |
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