Documentation of Humira in Psoriasis Patients in Routine Clinical Practice

Study Overview
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Brief Summary
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Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical Practice.

Detailed Description
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Postmarketing Observational Study to Evaluate the Work Productivity, Safety and Efficacy of Humira for the Treatment of Moderate to Severe Plaque Psoriasis in Daily Clinical Practice. The primary objectives of the PMOS are to explore changes in health related care utilization data by the evaluation of: the number of missed working days the number of visits to doctor's office the number and duration of hospitalizations work ability to assess efficacy for different subgroups by the number of patients achieving a PASI 75 response to evaluate safety by the documentation and analysis of adverse events for all patients and subgroups with concomitant diseases Secondary objectives include the exploration of changes in quality of life measurements, of the influence of age, gender and duration of disease

Official Title
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Long Term Documentation of the Safety and Efficacy as Well as the Effects on Work Productivity in Patients With Moderate to Severe Plaque Psoriasis Treated With HUMIRA (Adalimumab) in Routine Clinical Practice (LOTOS)

Conditions
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Moderate to Severe Plaque Psoriasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Moderate to severe plaque psoriasis in adults with no response to other systemic therapy (e.g. cyclosporine, methotrexate or PUVA (photochemical therapy)) or patients with a contraindication or hypersensitivity to such a therapy Exclusion Criteria: - Hypersensitivity against the drug or one of the other ingredients; active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections); moderate to severe cardiac insufficiency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Psoriasis Patients<br>Patients with moderate to severe plaque psoriasis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Psoriasis Area and Severity Index; number of patients with Psoriasis Area and Severity Index-75 reduction. |  | At 24, 48 and 60 months | 
| Changes in healthcare parameters: number of missed working days due to psoriasis; number of visits at the doctor's office; number and duration of hospitalizations, self-assessed workability. |  | At 24, 48 and 60 months | 
| Safety and tolerability assessed by analyzing serious and non-serous adverse events. |  | At 24, 48 and 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global physician's assessment on Humira treatment. |  | At 24, 48 and 60 months | 
| Target Nail Psoriasis Severity Index (target NAPSI). |  | At 24 months | 
| Itch Visual Analogue Scale (Itch VAS). |  | At 24 months | 
| Safety and tolerability of Humira - treatment for patient groups with frequent concommitant diseases, especially diabetes type I and II, cardio-vascular and liver and kidney functional impairment and respective concommitant medication. |  | At 24, 48 and 60 months | 
| Palmoplantar Psoriasis Area Severity Index (pPASI). |  | At 24 months | 
| Influence of body mass index and weight on efficacy measurement. |  | At 24, 48 and 60 months | 
| Patients' assessment on Humira treatment. |  | At 24, 48 and 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate to Severe Plaque Psoriasis, Humira, Safety, Efficacy, Work Productivity