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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Collaborators:
Cato Research
JSS Medical Research Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01387815
First received: July 1, 2011
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

The current study will compare 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.


Condition
Psoriasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • The physician global assessment (PGA) of of "0" or "1" indicating clear or minimal disease according to the classification below. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Classification: 0-Clear, 1-Minimal, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.


Secondary Outcome Measures:
  • Time to achieving physician global assessment (PGA) ≤ 1 [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ] [ Designated as safety issue: No ]
  • Psoriasis and Arthritis Screening Questionnaire (PASQ) [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ] [ Designated as safety issue: No ]
    This is an 11 item tool that ascertains self reported presence of joint pain and swelling

  • Patient Global Assessment of Disease Activity based on a six point Likert Scale [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ] [ Designated as safety issue: No ]
    Classification: Clear, Minimal, Mild, Moderate, Severe, Very Severe.

  • Dermatology Quality of Life Index (DLQI) [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ] [ Designated as safety issue: No ]
    Self administered questionnaire comprised of 10 items assessing a patient's skin and problems associated with skin disease.


Estimated Enrollment: 660
Study Start Date: August 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Topical Agents
patients with a new topical agent that was not used before or already on treatment with a topical agent and not responding
Traditional Systemic Agents
patients with a new systemic agent that was not used before alone or in combination with topical agents
Adalimumab
patients with adalimumab alone or in combination with topical agents

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Offices of community dermatologists

Criteria

Inclusion Criteria:

  • Active moderate or severe Plaque PS 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 patient preference.

Exclusion Criteria:

  • Currently participating in another prospective study with similar objectives.
  • Patient cannot or will not sign informed consent.
  • Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of Plaque PS.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387815

Contacts
Contact: Annie Daudrumez 514-832-7498 annie.daudrumez@abbvie.com
Contact: Josée Lafortune 514-832-7435 josee.lafortune@abbvie.com

  Show 83 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Cato Research
JSS Medical Research Inc.
Investigators
Study Director: Linda Assouline, PhD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01387815     History of Changes
Other Study ID Numbers: P12-678
Study First Received: July 1, 2011
Last Updated: July 21, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by AbbVie:
Traditional Systemic Agents
Psoriasis
Topical Agents
Adalimumab
Observational
Prospective
Comparative
Effectiveness

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 26, 2014