NCT01077232

Documentation of Humira in Psoriasis Patients in Routine Clinical Practice

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,442 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Conditions

• Moderate to Severe Plaque Psoriasis

Timeline

• Start date: 2008-01-04
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2010-03-01
• Last updated: 2020-06-12

Locations

641 sites across 1 country: Germany