Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis (Complete-PS)

AbbVie

Status: Completed

Conditions: Psoriasis

Treatments: Biological: Adalimumab

Study type: Observational

Funder types: Industry

Identifiers

NCT01387815

P12-678

Details and patient eligibility

About

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.

Full 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.

Enrollment: 662 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active moderate or severe plaque psoriasis according to the judgment of the treating physician.
• The treating physician has decided to change the current treatment or add additional treatments for any reason including but not limited to inadequate response, intolerance, sub-optimal compliance or participant preference.

Exclusion criteria

• Had currently participated in another prospective study with similar objectives.
• Participant could not or would not sign informed consent.
• Presence of other condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscured the assessment of the treatment of plaque psoriasis.

Trial design

662 participants in 2 patient groups

Topical/Traditional Systemic Agent

Description:

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.

Adalimumab

Description:

Participants treated with adalimumab alone or in combination with topical agents.

Treatment:

Biological: Adalimumab