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
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||662 participants|
|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|
patients with a new topical agent that was not used before or already on treatment with a topical agent and not responding
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
- 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.
- 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 ]
- 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
- 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.
- 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.
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
|Study Director:||AbbVie Inc.||AbbVie|