NCT01401452

Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 246 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, post marketing observational study (PMOS) was designed to evaluate the effectiveness of adalimumab over a period of 9 months as determined by the Psoriasis Area and Severity Index (PASI) in participants with moderate to severe plaque psoriasis with distinct co-morbidities. Secondary objectives of this study were to measure changes in psychological health via the Dermatology Life Quality Index (DLQI); changes in comorbidities with respect to gender; changes in quality of life using the Short Form Health Survey (SF-36); and evaluation of Minimal Clinically Important Differences (MCID).

Detailed description

Male or female participants ages 18 years of age and older for whom the treating physician had recently prescribed adalimumab were included in this study. Adalimumab was prescribed in accordance with the terms of the local marketing authorization with regards to dose, population, and indication. There were 5 planned visits during the study: baseline (Visit 1), 1 month (Visit 2), 3 months (Visit 3), 6 months (Visit 4), and 9 months (Visit 5).

Conditions

• Moderate to Severe Plaque Psoriasis

Timeline

• Start date: 2011-08-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2011-07-25
• Last updated: 2017-10-04
• Results posted: 2017-10-04