Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis

NCT ID: NCT01387815

Last Updated: 2019-12-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

662 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-16

Study Completion Date

2018-06-29

Brief Summary

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This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design that compared 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.

Detailed Description

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This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design. Participants were entered into one of two study cohorts (adalimumab cohort or topical/traditional systemic cohort) at the time of change of their psoriasis treatment for any reason and were followed for a maximum of 24 months with recommended assessments at 3, 6, 12, 18 and 24 months after baseline. Treatment of the participants and follow up were according to the physician's judgment, regional regulations, and the product monograph. Off-label use was not permitted, and these participants were not included in the study. Dose changes including escalation were allowed as per the physician's judgment for participants that were treated as per indication when they were enrolled in the study.

Conditions

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Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Topical/Traditional Systemic Agent

Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.

No interventions assigned to this group

Adalimumab

Participants treated with adalimumab alone or in combination with topical agents.

Adalimumab

Intervention Type BIOLOGICAL

Adalimumab administered by subcutaneous injection.

Interventions

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Adalimumab

Adalimumab administered by subcutaneous injection.

Intervention Type BIOLOGICAL

Other Intervention Names

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Humira

Eligibility Criteria

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Inclusion Criteria

* Active moderate or severe plaque psoriasis 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 participant preference.

Exclusion Criteria

* Had currently participated in another prospective study with similar objectives.
* Participant could not or would not sign informed consent.
* Presence of other condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscured the assessment of the treatment of plaque psoriasis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cato Research

INDUSTRY

Sponsor Role collaborator

JSS Medical Research Inc.

INDUSTRY

Sponsor Role collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Kirk Barber Research, CA /ID# 57722

Calgary, Alberta, Canada

Site Status

Richmond Road Diagnostic Treat /ID# 70913

Calgary, Alberta, Canada

Site Status

Institute for Skin Advancement /ID# 66782

Calgary, Alberta, Canada

Site Status

Thomas Nakatsui P.C. /ID# 55080

Edmonton, Alberta, Canada

Site Status

Alberta DermaSurgery Centre /ID# 75513

Edmonton, Alberta, Canada

Site Status

Wellington Medical Clinic Ltd. /ID# 55083

Nanaimo, British Columbia, Canada

Site Status

Percuro Clinical Research, Ltd /ID# 54563

Victoria, British Columbia, Canada

Site Status

Jason Ronald Sneath Medical Co /ID# 138026

Brandon, Manitoba, Canada

Site Status

Winnipeg Clinic, Manitoba, CA /ID# 56865

Winnipeg, Manitoba, Canada

Site Status

Maritime Medical Reseach Cente /ID# 128775

Bathurst, New Brunswick, Canada

Site Status

Dr. Irina Turchin PC Inc. /ID# 66029

Fredericton, New Brunswick, Canada

Site Status

Dermatologue Inc. /ID# 76074

Moncton, New Brunswick, Canada

Site Status

Douglas N. Keeling MD Dermatol /ID# 55098

Quispamsis, New Brunswick, Canada

Site Status

Karma Clinical Trials /ID# 55101

St. John's, Newfoundland and Labrador, Canada

Site Status

Nexus Clinical Research /ID# 56403

St. John's, Newfoundland and Labrador, Canada

Site Status

Eastern Canada Cutaneous Resea /ID# 46353

Halifax, Nova Scotia, Canada

Site Status

SimcoDerm Medical and Surgical /ID# 96915

Barrie, Ontario, Canada

Site Status

Kingsway Clinical Research /ID# 97255

Etobicoke, Ontario, Canada

Site Status

Giroux, Sudbury, CA /ID# 55128

Greater Sudbury, Ontario, Canada

Site Status

Dermatrials Research /ID# 124138

Hamilton, Ontario, Canada

Site Status

Dr. Wei Jing Loo Medicine Prof /ID# 127546

London, Ontario, Canada

Site Status

Lynderm Research Inc. /ID# 63206

Markham, Ontario, Canada

Site Status

Toronto Regional Wound Healing /ID# 55135

Mississauga, Ontario, Canada

Site Status

Dr. Anna Hinek Medicine Prof /ID# 148305

Mississauga, Ontario, Canada

Site Status

Oakville Derma and Laser, CA /ID# 55130

Oakville, Ontario, Canada

Site Status

Dr. Melinda Gooderham Medicine /ID# 54566

Peterborough, Ontario, Canada

Site Status

York Dermatology Center /ID# 127786

Richmond Hill, Ontario, Canada

Site Status

Specialized Dermatology Inc. /ID# 64031

St. Catharines, Ontario, Canada

Site Status

Lori Shapiro Medicine Prof Inc /ID# 55126

Thornhill, Ontario, Canada

Site Status

Toronto Dermatology Centre /ID# 55127

Toronto, Ontario, Canada

Site Status

Dr. Isabelle Delorme Inc. /ID# 57791

Drummondville, Quebec, Canada

Site Status

Dre. Angelique Gagne-Henley /ID# 125204

Montreal, Quebec, Canada

Site Status

Dr. Loukia-Maria Mitsos /ID# 124156

Pierrefonds, Quebec, Canada

Site Status

Dermatologie Sima Inc. /ID# 54922

Verdun, Quebec, Canada

Site Status

Dr. Beatrice Wang /ID# 63242

Westmount, Quebec, Canada

Site Status

Royal Univ. Hosp, Saskatoon,CA /ID# 74613

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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P12-678

Identifier Type: -

Identifier Source: org_study_id

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