Canadian Humira Post Marketing Observational Epidemiological Study : Assessing Humira Real-life Effectiveness and Impact on HS Burden of Illness
SOLACE
1 other identifier
observational
165
1 country
22
Brief Summary
This study assesses Humira's® real-life effectiveness in the management of dermatological manifestations of moderate to severe Hidradenitis Suppurativa (HS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2016
Typical duration for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2016
CompletedFirst Posted
Study publicly available on registry
September 12, 2016
CompletedStudy Start
First participant enrolled
September 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2019
CompletedMay 1, 2020
April 1, 2020
2.6 years
September 7, 2016
April 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants achieving clinical response using the Hidradenitis Suppurativa Clinical Response measure (HiSCR) at week 24
The HiSCR measure is defined as at least a 50% reduction in the Abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline.
At Week 24
Secondary Outcomes (13)
Proportion of participants who experience flare
Up to Week 52
Change from Baseline in Hospital Anxiety and Depression Scale (HADS)
From Week 0 (baseline) to Week 52
Change from Baseline in International Index of Erectile Function (IIEF)
From Week 0 (baseline) to Week 52
Change from Baseline in Health Care Resource Utilization (HCRU) associated with HS
From Week 0 (baseline) to Week 52
Change from Baseline in Patient Global Assessment of HS (HS-PtGA)
From Week 0 (baseline) to Week 52
- +8 more secondary outcomes
Study Arms (1)
Participants receiving adalimumab/ Humira®
Participants with HS for whom a change in treatment to Humira® is made by the treating physician
Eligibility Criteria
Participants with moderate or severe HS
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (22)
Institute for Skin Advancement /ID# 152448
Calgary, Alberta, T3A 2N1, Canada
Alberta DermaSurgery Centre /ID# 153834
Edmonton, Alberta, T6G 1C3, Canada
Jason Ronald Sneath Medical Co /ID# 152462
Brandon, Manitoba, R7A 0L5, Canada
Winnipeg Clinic, Manitoba, CA /ID# 153830
Winnipeg, Manitoba, R3C 1T6, Canada
Wiseman Dermatology Research /ID# 153835
Winnipeg, Manitoba, R3M 3Z4, Canada
Dr. Irina Turchin PC Inc. /ID# 152464
Fredericton, New Brunswick, E3B 1G9, Canada
Karma Clinical Trials /ID# 152444
St. John's, Newfoundland and Labrador, A1A 4Y3, Canada
NewLab Clinical Research Inc. /ID# 152438
St. John's, Newfoundland and Labrador, A1C 2H5, Canada
Dr. Brown-Maher PMC INC. /ID# 152407
St. John's, Newfoundland and Labrador, A1E 1V4, Canada
Eastern Canada Cutaneous Resea /ID# 153832
Halifax, Nova Scotia, B3H 1Z2, Canada
SimcoMed Health Ltd /ID# 152445
Barrie, Ontario, L4M 7G1, Canada
Dr. Wei Jing Loo Medicine Prof /ID# 157923
London, Ontario, N6H 5L5, Canada
Lynderm Research Inc. /ID# 152436
Markham, Ontario, L3P 1X2, Canada
SKIN Centre for Dermatology /ID# 152457
Peterborough, Ontario, K9J 5K2, Canada
York Dermatology Center /ID# 152403
Richmond Hill, Ontario, L4C 9M7, Canada
Niakosari Medicine Professional Corporation /ID# 157851
Toronto, Ontario, M2M 4J5, Canada
K. Papp Clinical Research /ID# 152446
Waterloo, Ontario, N2J 1C4, Canada
Dr. Isabelle Delorme Inc. /ID# 152408
Drummondville, Quebec, J2B 5L4, Canada
Clinique D /ID# 152406
Laval, Quebec, H7N 6L2, Canada
Dre. Angelique Gagne-Henley /ID# 152611
Saint-Jérôme, Quebec, J7Z 7E2, Canada
Dermatologie Sima Inc. /ID# 152443
Verdun, Quebec, H4G 3E7, Canada
Hopital St-Sacrement /ID# 152456
Québec, M5C1R6, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2016
First Posted
September 12, 2016
Study Start
September 20, 2016
Primary Completion
April 29, 2019
Study Completion
April 29, 2019
Last Updated
May 1, 2020
Record last verified: 2020-04