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The aim of this study is to obtain Venezuelan data of clinical effectiveness, impact in the HRQoL, work productivity and activity impairment in patients with psoriasis using adalimumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Cohort 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in PASI 75 (Psoriasis Area and Severity Index score) Response Rate | From Week 0 to Week 16 | |
| Change in Percentage of patients with clinical difference in DLQI (Dermatology Life Quality Index) score | Clinical difference is defined by a minimal important difference (MID) in DLQI score between 2.3-5 at 16 weeks | From Week 0 to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change of PASI score | From week 0 to week 16 | |
| Mean change of DLQI score | From week 0 to week 16 | |
| Changes in Psoriatic Arthritis Response Criteria (PsARC) score |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects male or female with moderate to severe chronic plaque psoriasis with or without psoriatic arthritis. Patients with history of psoriatic arthritis or articular symptoms must be evaluated by a Rheumatologist.
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| Name | Affiliation | Role |
|---|---|---|
| Natali Serra-Bonett, MD | Abbott | Study Chair |
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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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| From week 0 to week 16 |
| Mean change of Hospital Anxiety and Depression Score (HADS) | From week 0 to week 16 |
| Mean change en Work Productivity and Activity Impairment (WPAI)-Psoriasis score | From week 0 to week 16 |
| Percentage of subjects with Serious Adverse Events (SAEs) | Occurrence of SAEs including tuberculosis, other opportunistic infections and cancer | Up to week 16 |
| Discontinuation of adalimumab for any reason. | Up to week 16 |