Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis (Complete-PS)
This study is currently recruiting participants.
Verified May 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborators:
CATO Research Canada
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: May 17, 2013
Last verified: May 2013
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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:
- Adult > 18 years old;
- Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel;
- Active moderate or severe Plaque Psoriasis defined as Body Surface Area (BSA) involvement ≥ 10% and Physician Global Assessment (PGA) of Psoriasis specific Disease Activity ≥ 3.0; where 0 = no disease (Clear) and 5 = very severe;
- Inadequate response, intolerance or lack of compliance with current treatment for Plaque Psoriasis indicating change in regimen as per the physician's judgment
Exclusion Criteria:
- Currently participating in another prospective study including controlled clinical trials and observational studies;
- Patient cannot or will not sign informed consent;
- Stable disease with adequate tolerance and response to current treatment and no change in treatment is indicated;
- 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 Psoriasis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387815
Contacts
| Contact: Annie Daudrumez | 514-832-7498 | annie.daudrumez@abbvie.com |
| Contact: Chantal Lacasse | 514-832-7728 | chantal.lacasse@abbvie.com |
Locations
| Canada | |
| Site Reference ID/Investigator# 70913 | Recruiting |
| Calgary, Canada | |
| Principal Investigator: Site Reference ID/Investigator# 70913 | |
| Site Reference ID/Investigator# 66782 | Recruiting |
| Calgary, Canada, T3A 2N1 | |
| Principal Investigator: Site Reference ID/Investigator# 66782 | |
| Site Reference ID/Investigator# 57722 | Recruiting |
| Calgary, Canada, T2S 3B3 | |
| Principal Investigator: Site Reference ID/Investigator# 57722 | |
| Site Reference ID/Investigator# 55080 | Recruiting |
| Edmonton, Canada | |
| Principal Investigator: Site Reference ID/Investigator# 55080 | |
| Site Reference ID/Investigator# 63206 | Recruiting |
| Markham, Canada, L3P 1A8 | |
| Principal Investigator: Site Reference ID/Investigator# 63206 | |
| Site Reference ID/Investigator# 55135 | Recruiting |
| Mississauga, Canada | |
| Principal Investigator: Site Reference ID/Investigator# 55135 | |
| Site Reference ID/Investigator# 76074 | Recruiting |
| Moncton, Canada, E1C 8X3 | |
| Principal Investigator: Site Reference ID/Investigator# 76074 | |
| Site Reference ID/Investigator# 55083 | Recruiting |
| Nanaimo, Canada | |
| Principal Investigator: Site Reference ID/Investigator# 55083 | |
| Site Reference ID/Investigator# 55130 | Recruiting |
| Oakville, Canada, L6J 7W5 | |
| Principal Investigator: Site Reference ID/Investigator# 55130 | |
| Site Reference ID/Investigator# 54566 | Recruiting |
| Peterborough, Canada, K9J 1Z2 | |
| Principal Investigator: Site Reference ID/Investigator# 54566 | |
| Site Reference ID/Investigator# 55098 | Recruiting |
| Quispamsis, Canada | |
| Principal Investigator: Site Reference ID/Investigator# 55098 | |
| Site Reference ID/Investigator# 74613 | Recruiting |
| Saskatoon, Canada, S7N 0W8 | |
| Principal Investigator: Site Reference ID/Investigator# 74613 | |
| Site Reference ID/Investigator# 57791 | Recruiting |
| St-Hyacinthe, Canada, J2S 6L6 | |
| Principal Investigator: Site Reference ID/Investigator# 57791 | |
| Site Reference ID/Investigator# 55101 | Recruiting |
| St. John's, Canada, A1A 4Y3 | |
| Principal Investigator: Site Reference ID/Investigator# 55101 | |
| Site Reference ID/Investigator# 56403 | Recruiting |
| St. John's, Canada, A1A 5E8 | |
| Principal Investigator: Site Reference ID/Investigator# 56403 | |
| Site Reference ID/Investigator# 55128 | Recruiting |
| Sudbury, Canada | |
| Principal Investigator: Site Reference ID/Investigator# 55128 | |
| Site Reference ID/Investigator# 55126 | Recruiting |
| Thornhill, Canada | |
| Principal Investigator: Site Reference ID/Investigator# 55126 | |
| Site Reference ID/Investigator# 55127 | Recruiting |
| Toronto, Canada, M3H 5Y8 | |
| Principal Investigator: Site Reference ID/Investigator# 55127 | |
| Site Reference ID/Investigator# 54922 | Recruiting |
| Verdun, Canada | |
| Principal Investigator: Site Reference ID/Investigator# 54922 | |
| Site Reference ID/Investigator# 54563 | Recruiting |
| Victoria, Canada, V8V 3P9 | |
| Principal Investigator: Site Reference ID/Investigator# 54563 | |
| Site Reference ID/Investigator# 64031 | Recruiting |
| Welland, Canada, L3C 3W4 | |
| Principal Investigator: Site Reference ID/Investigator# 64031 | |
| Site Reference ID/Investigator# 63242 | Recruiting |
| Westmount, Canada, H3Z 2S6 | |
| Principal Investigator: Site Reference ID/Investigator# 63242 | |
| Site Reference ID/Investigator# 56865 | Recruiting |
| Winnipeg, Canada, R3C 0N2 | |
| Principal Investigator: Site Reference ID/Investigator# 56865 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
CATO Research Canada
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: | May 17, 2013 |
| 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 May 22, 2013