NCT01387815

Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 662 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design that compared the real - life effectiveness of adalimumab to topical and traditional systemic agents in the management of psoriasis and its impact on the patient's quality of life and societal burden of illness.

Detailed description

This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design. Participants were entered into one of two study cohorts (adalimumab cohort or topical/traditional systemic cohort) at the time of change of their psoriasis treatment for any reason and were followed for a maximum of 24 months with recommended assessments at 3, 6, 12, 18 and 24 months after baseline. Treatment of the participants and follow up were according to the physician's judgment, regional regulations, and the product monograph. Off-label use was not permitted, and these participants were not included in the study. Dose changes including escalation were allowed as per the physician's judgment for participants that were treated as per indication when they were enrolled in the study.

Conditions

• Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	Adalimumab	Adalimumab administered by subcutaneous injection.

Timeline

• Start date: 2011-08-16
• Primary completion: 2018-06-29
• Completion: 2018-06-29
• First posted: 2011-07-06
• Last updated: 2019-12-05
• Results posted: 2019-12-05

Locations

36 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study