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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01387815
Recruitment Status : Active, not recruiting
First Posted : July 6, 2011
Last Update Posted : October 9, 2017
Information provided by (Responsible Party):

Study Description
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

Study Design

Study Type : Observational
Estimated Enrollment : 660 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis
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

Groups and 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
patients with adalimumab alone or in combination with topical agents

Outcome Measures

Primary Outcome Measures :
  1. The physician global assessment (PGA) of 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.

Eligibility Criteria

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

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

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

SimcoDerm Medical and Surgical Dermatology Center /ID# 96915
Barrie, Canada, L4M 7G1
Maritime Medical Reseach Center /ID# 128775
Bathurst, Canada, E2A 4Z9
Dr. Jason Ronald Sneath Medical Corporation /ID# 138026
Brandon,, Canada, R7A 0L5
Kirk Barber Research, Calgary, Alberta, Canada /ID# 57722
Calgary, Canada, T2G 1B1
Richmond Road Diagnostic Treatment Centre /ID# 70913
Calgary, Canada, T2T 5C7
Institute for Skin Advancement Inc. /ID# 66782
Calgary, Canada, T3A 2N1
Dr. Isabelle Delorme Inc. /ID# 57791
Drummondville, Canada, J2B 5L4
Thomas Nakatsui P.C. /ID# 55080
Edmonton, Canada, T5N 4B2
Alberta Laser and Dermatology Centre /ID# 75513
Edmonton, Canada, T6G 1C3
Kingsway Clinical Research /ID# 97255
Etobicoke, Canada, M8X 1Y9
Dr. Irina Turchin PC Inc. /ID# 66029
Fredericton, Canada, E3B 1G9
Eastern Canada Cutaneous Research Associates Ltd. /ID# 46353
Halifax, Canada, B3H 1Z4
Dermatrials Research Inc. /ID# 124138
Hamilton, Canada, L8N 1Y2
Dr. Wei Jing Loo Medicine Professional Corporation /ID# 127546
London, Canada, N6H 5L5
Lynderm Research Inc. /ID# 63206
Markham, Canada, L3P 1X2
Toronto Regional Wound Healing Clinic /ID# 55135
Mississauga, Canada, L4Y 1A6
Dr. Anna Hinek Medicine Profesional Corporation /ID# 148305
Mississauga, Canada, L5M 2V8
Dermatologue Inc. /ID# 76074
Moncton, Canada, E1C 8X3
Wellington Medical Clinic Ltd. /ID# 55083
Nanaimo, Canada, V9T 1W1
Oakville Dermatology and Laser Center /ID# 55130
Oakville, Canada, L6J 7W5
Dr. Melinda Gooderham Medicine Professional Corporation /ID# 54566
Peterborough,, Canada, K9J 5K2
Mitsos, Pierrefonds, CA /ID# 124156
Pierrefonds, Canada, H8Z 1W5
Douglas N. Keeling MD Dermatologist PC /ID# 55098
Quispamsis, Canada, E2E 4Z4
York Dermatology Center /ID# 127786
Richmond Hill, Canada, L4C 9M7
Dre. Angelique Gagne-Henley M.D. Inc. /ID# 125204
Saint-Jerome, Canada, J7Z 3B8
Royal University Hospital, Saskatoon, SK, Canada /ID# 74613
Saskatoon, Canada, S7N 0W8
Specialized Dermatology Inc. /ID# 64031
St-Catharines, Canada, L2R 5W4
Karma Clinical Trials /ID# 55101
St. John's, Canada, A1A 4Y3
Nexus Clinical Research /ID# 56403
St. John's, Canada, A1A 5E8
Dr. Lyne Giroux, Sudbury, CA /ID# 55128
Sudbury, Canada, P3C 1X8
Lori Shapiro Medicine Professional Incorporation /ID# 55126
Thornhill, Canada, L4J 3M6
Toronto Dermatology Centre /ID# 55127
Toronto, Canada, M3H 5Y8
Dermatologie Sima Inc. /ID# 54922
Verdun, Canada, H4G 3E7
Percuro Clinical Research, Ltd. /ID# 54563
Victoria, Canada, V8V 3M9
Dr. Beatrice Wang /ID# 63242
Westmount, Canada, H3Z 2S6
Winnipeg Clinic, Manitoba, Canada /ID# 56865
Winnipeg, Canada, R3C 0N2
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Cato Research
JSS Medical Research Inc.
Study Director: Christina Pelizon, MD AbbVie
More Information

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: October 9, 2017
Last Verified: October 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Topical Agents
Traditional Systemic Agents

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