Documentation of Humira in Psoriasis Patients in Routine Clinical Practice
- Conditions
- Moderate to Severe Plaque Psoriasis
- Registration Number
- NCT01077232
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical Practice.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5442
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Changes in Psoriasis Area and Severity Index; number of patients with Psoriasis Area and Severity Index-75 reduction. 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
Name Time Method Influence of body mass index and weight on efficacy measurement. At 24, 48 and 60 months Global physician's assessment on Humira treatment. At 24, 48 and 60 months Target Nail Psoriasis Severity Index (target NAPSI). 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 Patients' assessment on Humira treatment. At 24, 48 and 60 months Itch Visual Analogue Scale (Itch VAS). At 24 months Palmoplantar Psoriasis Area Severity Index (pPASI). At 24 months
Trial Locations
- Locations (641)
Universitaetsklinik Heidelberg /ID# 33810
🇩🇪Heidelberg, Baden-Wuerttemberg, Germany
Universitaetsklinik Heidelberg /ID# 50858
🇩🇪Heidelberg, Baden-Wuerttemberg, Germany
Universitatsklinikum Mannheim /ID# 166130
🇩🇪Mannheim, Baden-Wuerttemberg, Germany
Universitaetsklinikum Erlangen /ID# 34816
🇩🇪Erlangen, Bayern, Germany
Universitätsklinikum Frankfurt /ID# 53725
🇩🇪Frankfurt am Main, Hessen, Germany
Universitatsklinikum Munster /ID# 205840
🇩🇪Munster, Niedersachsen, Germany
Universitatsklinikum Munster /ID# 72018
🇩🇪Munster, Niedersachsen, Germany
Universitatsklinikum Munster /ID# 72022
🇩🇪Munster, Niedersachsen, Germany
Praxis M. Vilic /ID# 210108
🇩🇪Aachen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Aachen /ID# 35037
🇩🇪Aachen, Nordrhein-Westfalen, Germany
Scroll for more (631 remaining)Universitaetsklinik Heidelberg /ID# 33810🇩🇪Heidelberg, Baden-Wuerttemberg, Germany