NCT01155570

Special Investigation in Patients With Psoriasis Vulgaris and Psoriatic Arthritis (All Patients Investigation)

Special Investigation (All Cases Investigation in Patients With Psoriasis Vulgaris and Psoriatic Arthritis)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 752 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The survey will be conducted with regard to the following aspects of treatment with Humira (adalimumab) in patients with psoriasis vulgaris and psoriatic arthritis receiving this drug: * unknown adverse drug reactions, especially clinically significant adverse reactions * incidence and conditions of occurrence of adverse reactions in the clinical setting * factors that may affect the safety and effectiveness of Humira.

Detailed description

This study was non-interventional, open-labeled, all-cases, central registration method, post marketing observational study in which Humira was prescribed for patients with psoriasis vulgaris and/or psoriatic arthritis in routine medical practice. When investigators prescribed Humira to an eligible patient who provided informed consent, they filled out a registration form and send it to the registration center via postal mail. At the end of the 24-week observation period, an investigator filled out a case report form for each patient to describe the findings during the study period, and provided the completed form to medical representatives. Even if Humira treatment was for any reason discontinued, the investigators followed each such participant for 24 weeks after the first administration of Humira, and filled out a case report form for the participant at the end of the 24-week period. Some participants entered this study from study NCT00647400 (M04-702), a Phase III extension study of Humira (adalimumab) in Japan.

Conditions

• Psoriasis

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-07-02
• Last updated: 2013-10-08
• Results posted: 2013-10-08

Locations

634 sites across 1 country: Japan