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

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01387815
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — BIOLOGICAL
    Adalimumab administered by subcutaneous injection.

Study Details

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.

Key Dates

Start date
Aug 16, 2011
Status verified
Nov 2019
Primary completion
Jun 29, 2018
Completion
Jun 29, 2018

Study Design

Enrollment
662 participants (actual)

Arms

  • Arm: Topical/Traditional Systemic Agent
    Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.
  • Arm: Adalimumab
    Participants treated with adalimumab alone or in combination with topical agents.

Primary Outcome Measure

Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at Month 6 [ Time Frame: Month 6 ]

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