NCT00513370

A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis

A Canadian Open-Label Access Program to Evaluate the Safety and the Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety profile, the effectiveness and the economic impact of adalimumab when used for the treatment of subjects with active plaque psoriasis who have not adequately responded to prior psoriasis therapy.

Conditions

• Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	Humira (adalimumab)	Study drug will be provided as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). Loading dose of 80 mg of adalimumab subcutaneously (sc) at Baseline, and 40 mg of adalimumab sc at Week 1, followed by 40 mg of adalimumab sc every other week (eow) for 24 weeks.

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-09-01
• First posted: 2007-08-08
• Last updated: 2011-04-11
• Results posted: 2009-11-20

Locations

27 sites across 1 country: Canada