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

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ClinicalTrials.gov Identifier: NCT01387815
Recruitment Status : Active, not recruiting
First Posted : July 6, 2011
Last Update Posted : May 1, 2018
Sponsor:
Collaborators:
Cato Research
JSS Medical Research Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
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 or disease
Psoriasis

Study Type : Observational
Actual Enrollment : 662 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis
Actual Study Start Date : August 16, 2011
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab
U.S. FDA Resources

Group/Cohort
Topical Agents
patients with a new topical agent that was not used before or already on treatment with a topical agent and not responding
Adalimumab
patients with adalimumab alone or in combination with topical agents
Traditional Systemic Agents
patients with a new systemic agent that was not used before alone or in combination with topical agents



Primary Outcome Measures :
  1. The physician global assessment (PGA) of "0" or "1" indicating clear or minimal disease according to the classification below. [ Time Frame: 6 month ]
    Classification: 0-Clear, 1-Minimal, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.


Secondary Outcome Measures :
  1. 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 ]
  2. Psoriasis and Arthritis Screening Questionnaire (PASQ) [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ]
    This is an 11 item tool that ascertains self reported presence of joint pain and swelling

  3. 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 ]
    Classification: Clear, Minimal, Mild, Moderate, Severe, Very Severe.

  4. Dermatology Quality of Life Index (DLQI) [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ]
    Self administered questionnaire comprised of 10 items assessing a patient's skin and problems associated with skin disease.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387815


  Show 36 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Cato Research
JSS Medical Research Inc.
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01387815     History of Changes
Other Study ID Numbers: P12-678
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Effectiveness
Psoriasis
Observational
Prospective
Adalimumab
Traditional Systemic Agents
Topical Agents
Comparative

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