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

This study is ongoing, but not recruiting participants.
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 15, 2016
Last verified: July 2016
  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 2018
Estimated Primary Completion Date: June 2018 (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 to 99 Years   (Adult, Senior)
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

Locations
Canada
Site Reference ID/Investigator# 96915
Barrie, Canada, L4M 7G1
Site Reference ID/Investigator# 128775
Bathurst, Canada, E2A 4Z9
Site Reference ID/Investigator# 138026
Brandon,, Canada, R7A 0L5
Site Reference ID/Investigator# 57722
Calgary, Canada, T2G 1B1
Site Reference ID/Investigator# 70913
Calgary, Canada, T2T 5C7
Site Reference ID/Investigator# 66782
Calgary, Canada, T3A 2N1
Site Reference ID/Investigator# 57791
Drummondville, Canada, J2B 5L4
Site Reference ID/Investigator# 55080
Edmonton, Canada, T5N 4B2
Site Reference ID/Investigator# 75513
Edmonton, Canada, T6G 1C3
Site Reference ID/Investigator# 97255
Etobicoke, Canada, M8X 1Y9
Site Reference ID/Investigator# 66029
Fredericton, Canada, E3B 1G9
Site Reference ID/Investigator# 46353
Halifax, Canada, B3H 1Z4
Site Reference ID/Investigator# 124138
Hamilton, Canada, L8N 1V6
Site Reference ID/Investigator# 127546
London, Canada, N6H 5L5
Site Reference ID/Investigator# 63206
Markham, Canada, L3P 1X2
Site Reference ID/Investigator# 55135
Mississauga, Canada, L4Y 1A6
Site Reference ID/Investigator# 148305
Mississauga, Canada, L5M 2V8
Site Reference ID/Investigator# 76074
Moncton, Canada, E1C 8X3
Site Reference ID/Investigator# 55083
Nanaimo, Canada, V9T 1W1
Site Reference ID/Investigator# 55130
Oakville, Canada, L6J 7W5
Site Reference ID/Investigator# 54566
Peterborough,, Canada, K9J 5K2
Site Reference ID/Investigator# 124156
Pierrefonds, Canada, H8Z 1W5
Site Reference ID/Investigator# 55098
Quispamsis, Canada, E2E 4Z4
Site Reference ID/Investigator# 127786
Richmond Hill, Canada, L4C 9M7
Site Reference ID/Investigator# 125204
Saint-Jerome, Canada, J7Z 3B8
Site Reference ID/Investigator# 74613
Saskatoon, Canada, S7N 0W8
Site Reference ID/Investigator# 64031
St-Catharines, Canada, L2R 5W4
Site Reference ID/Investigator# 55101
St. John's, Canada, A1A 4Y3
Site Reference ID/Investigator# 56403
St. John's, Canada, A1A 5E8
Site Reference ID/Investigator# 55128
Sudbury, Canada, P3C 1X8
Site Reference ID/Investigator# 55126
Thornhill, Canada, L4J 3M6
Site Reference ID/Investigator# 55127
Toronto, Canada, M3H 5Y8
Site Reference ID/Investigator# 54922
Verdun, Canada, H4G 3E7
Site Reference ID/Investigator# 54563
Victoria, Canada, V8V 3P9
Site Reference ID/Investigator# 63242
Westmount, Canada, H3Z 2S6
Site Reference ID/Investigator# 56865
Winnipeg, Canada, R3C 0N2
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Cato Research
JSS Medical Research Inc.
Investigators
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 
Study First Received: July 1, 2011
Last Updated: July 15, 2016
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on August 22, 2016