Canadian Humira Post Marketing Observational Epidemiological Study : Assessing Humira Real-life Effectiveness and Impact on HS Burden of Illness

NCT ID: NCT02896920

Last Updated: 2020-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-20

Study Completion Date

2019-04-29

Brief Summary

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This study assesses Humira's® real-life effectiveness in the management of dermatological manifestations of moderate to severe Hidradenitis Suppurativa (HS).

Detailed Description

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Conditions

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Hidradenitis Suppurativa (HS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants receiving adalimumab/ Humira®

Participants with HS for whom a change in treatment to Humira® is made by the treating physician

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Has a clinical diagnosis of moderate to severe HS according to the treating physician judgment
* Need a change in ongoing therapy for any reason, but not limited to inadequate response, intolerance, sub-optimal compliance, or patient preference. Patient will be approached to participate in the study after a decision to change patient's therapy for Humira® is made by the treating physician.
* Has provided written informed consent (Patient Authorization) for participation in the study

Exclusion Criteria

* Is participating in a clinical interventional study
* Was treated with Humira®, or any other biologic agents for HS prior to baseline visit
* Has any other active skin disease or 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 HS
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

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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Institute for Skin Advancement /ID# 152448

Calgary, Alberta, Canada

Site Status

Alberta DermaSurgery Centre /ID# 153834

Edmonton, Alberta, Canada

Site Status

Jason Ronald Sneath Medical Co /ID# 152462

Brandon, Manitoba, Canada

Site Status

Winnipeg Clinic, Manitoba, CA /ID# 153830

Winnipeg, Manitoba, Canada

Site Status

Wiseman Dermatology Research /ID# 153835

Winnipeg, Manitoba, Canada

Site Status

Dr. Irina Turchin PC Inc. /ID# 152464

Fredericton, New Brunswick, Canada

Site Status

Karma Clinical Trials /ID# 152444

St. John's, Newfoundland and Labrador, Canada

Site Status

NewLab Clinical Research Inc. /ID# 152438

St. John's, Newfoundland and Labrador, Canada

Site Status

Dr. Brown-Maher PMC INC. /ID# 152407

St. John's, Newfoundland and Labrador, Canada

Site Status

Eastern Canada Cutaneous Resea /ID# 153832

Halifax, Nova Scotia, Canada

Site Status

SimcoMed Health Ltd /ID# 152445

Barrie, Ontario, Canada

Site Status

Dr. Wei Jing Loo Medicine Prof /ID# 157923

London, Ontario, Canada

Site Status

Lynderm Research Inc. /ID# 152436

Markham, Ontario, Canada

Site Status

SKIN Centre for Dermatology /ID# 152457

Peterborough, Ontario, Canada

Site Status

York Dermatology Center /ID# 152403

Richmond Hill, Ontario, Canada

Site Status

Niakosari Medicine Professional Corporation /ID# 157851

Toronto, Ontario, Canada

Site Status

K. Papp Clinical Research /ID# 152446

Waterloo, Ontario, Canada

Site Status

Dr. Isabelle Delorme Inc. /ID# 152408

Drummondville, Quebec, Canada

Site Status

Clinique D /ID# 152406

Laval, Quebec, Canada

Site Status

Dre. Angelique Gagne-Henley /ID# 152611

Saint-Jérôme, Quebec, Canada

Site Status

Dermatologie Sima Inc. /ID# 152443

Verdun, Quebec, Canada

Site Status

Hopital St-Sacrement /ID# 152456

Québec, , Canada

Site Status

Countries

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Canada

Related Links

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Other Identifiers

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P15-696

Identifier Type: -

Identifier Source: org_study_id

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