Clinical trial NCT02896920: Canadian Humira Post Marketing Observational Epidemiological Study : Assessing Humira Real-life Effectiveness and Impact on HS Burden of Illness
Official title: Canadian Humira Post Marketing Observational Epidemiological Study : Assessing Humira Real-life Effectiveness and Impact on Hidradenitis Suppurativa (HS) Burden of Illness and Health Care Resources Utilization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hidradenitis Suppurativa (HS)
Keywords: Hidradenitis Suppurativa (HS)
Humira®
Canada
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-09-12
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with moderate or severe HS

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


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants achieving clinical response using the Hidradenitis Suppurativa Clinical Response measure (HiSCR) at week 24
timeFrame: At Week 24
Secondary outcomes:
measure: Proportion of participants who experience flare
timeFrame: Up to Week 52
measure: Change from Baseline in Hospital Anxiety and Depression Scale (HADS)
timeFrame: From Week 0 (baseline) to Week 52
measure: Change from Baseline in International Index of Erectile Function (IIEF)
timeFrame: From Week 0 (baseline) to Week 52
measure: Change from Baseline in Health Care Resource Utilization (HCRU) associated with HS
timeFrame: From Week 0 (baseline) to Week 52
measure: Change from Baseline in Patient Global Assessment of HS (HS-PtGA)
timeFrame: From Week 0 (baseline) to Week 52
measure: Proportion of participants achieving clinical response using the Hidradenitis Suppurativa Clinical Response measure (HiSCR) at week 52
timeFrame: At Week 52
measure: Change from Baseline in Health Utility Index Mark 3 (HUI3)
timeFrame: From Week 0 (baseline) to Week 52
measure: Change from Baseline in Female Sexual Function Index (FSFI)
timeFrame: From Week 0 (baseline) to Week 52
measure: Proportion of participants who experience worsening of HS by >= 1 Hurley Stage in >= 1 affected anatomic region
timeFrame: Up to Week 52
measure: Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA)
timeFrame: From Week 0 (baseline) to Week 52
measure: Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)
timeFrame: From Week 0 (baseline) to Week 52
measure: Change from Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem V2.0 (WPAI: SHP)
timeFrame: From Week 0 (baseline) to Week 52
measure: Number of days where participants experience HS flare-up
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Institute for Skin Advancement /ID# 152448
state: Alberta
city: Edmonton
country: Canada
facility: Alberta DermaSurgery Centre /ID# 153834
state: Alberta
city: Brandon
country: Canada
facility: Jason Ronald Sneath Medical Co /ID# 152462
state: Manitoba
city: Winnipeg
country: Canada
facility: Winnipeg Clinic, Manitoba, CA /ID# 153830
state: Manitoba
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research /ID# 153835
state: Manitoba
city: Fredericton
country: Canada
facility: Dr. Irina Turchin PC Inc. /ID# 152464
state: New Brunswick
city: St. John's
country: Canada
facility: Karma Clinical Trials /ID# 152444
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: NewLab Clinical Research Inc. /ID# 152438
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Dr. Brown-Maher PMC INC. /ID# 152407
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Resea /ID# 153832
state: Nova Scotia
city: Barrie
country: Canada
facility: SimcoMed Health Ltd /ID# 152445
state: Ontario
city: London
country: Canada
facility: Dr. Wei Jing Loo Medicine Prof /ID# 157923
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc. /ID# 152436
state: Ontario
city: Peterborough
country: Canada
facility: SKIN Centre for Dermatology /ID# 152457
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Center /ID# 152403
state: Ontario
city: Toronto
country: Canada
facility: Niakosari Medicine Professional Corporation /ID# 157851
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research /ID# 152446
state: Ontario
city: Drummondville
country: Canada
facility: Dr. Isabelle Delorme Inc. /ID# 152408
state: Quebec
city: Laval
country: Canada
facility: Clinique D /ID# 152406
state: Quebec
city: St-Jerome
country: Canada
facility: Dre. Angelique Gagne-Henley /ID# 152611
state: Quebec
city: Verdun
country: Canada
facility: Dermatologie Sima Inc. /ID# 152443
state: Quebec
city: Quebec
country: Canada
facility: Hopital St-Sacrement /ID# 152456
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: