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

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

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

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa (HS)

• Study Type: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, M5C1R6
    • Hopital St-Sacrement /ID# 152456
  • Alberta
    • Calgary, Alberta, Canada, T3A 2N1
      • Institute for Skin Advancement /ID# 152448
    • Edmonton, Alberta, Canada, T6G 1C3
      • Alberta DermaSurgery Centre /ID# 153834
  • Manitoba
    • Brandon, Manitoba, Canada, R7A 0L5
      • Jason Ronald Sneath Medical Co /ID# 152462
    • Winnipeg, Manitoba, Canada, R3C 1T6
      • Winnipeg Clinic, Manitoba, CA /ID# 153830
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research /ID# 153835
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Dr. Irina Turchin PC Inc. /ID# 152464
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
      • Karma Clinical Trials /ID# 152444
    • St. John's, Newfoundland and Labrador, Canada, A1C 2H5
      • NewLab Clinical Research Inc. /ID# 152438
    • St. John's, Newfoundland and Labrador, Canada, A1E 1V4
      • Dr. Brown-Maher PMC INC. /ID# 152407
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1Z2
      • Eastern Canada Cutaneous Resea /ID# 153832
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • SimcoMed Health Ltd /ID# 152445
    • London, Ontario, Canada, N6H 5L5
      • Dr. Wei Jing Loo Medicine Prof /ID# 157923
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc. /ID# 152436
    • Peterborough, Ontario, Canada, K9J 5K2
      • SKIN Centre for Dermatology /ID# 152457
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • York Dermatology Center /ID# 152403
    • Toronto, Ontario, Canada, M2M 4J5
      • Niakosari Medicine Professional Corporation /ID# 157851
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research /ID# 152446
  • Quebec
    • Drummondville, Quebec, Canada, J2B 5L4
      • Dr. Isabelle Delorme Inc. /ID# 152408
    • Laval, Quebec, Canada, H7N 6L2
      • Clinique D /ID# 152406
    • St-Jerome, Quebec, Canada, J7Z 7E2
      • Dre. Angelique Gagne-Henley /ID# 152611
    • Verdun, Quebec, Canada, H4G 3E7
      • Dermatologie Sima Inc. /ID# 152443

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with moderate or severe HS

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants receiving adalimumab/ Humira®; Participants with HS for whom a change in treatment to Humira® is made by the treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who experience flare	It is defined as at least 25% increase in AN counts with a minimum increase of 2 relative to baseline	Up to Week 52
Change from Baseline in Hospital Anxiety and Depression Scale (HADS)	The HADS questionnaire includes 14 questions that evaluate the level of anxiety and depression an HS patient may experience associated with HS. A lower score indicates less severity.	From Week 0 (baseline) to Week 52
Change from Baseline in International Index of Erectile Function (IIEF)	The IIEF contains 15 questions that were assigned in 5 domains of male sexuality: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction.	From Week 0 (baseline) to Week 52
Change from Baseline in Health Care Resource Utilization (HCRU) associated with HS	This will be assessed using a descriptive questionnaire that aimed at measuring the patient's health care resource utilization and economic impact of HS.	From Week 0 (baseline) to Week 52
Change from Baseline in Patient Global Assessment of HS (HS-PtGA)	The HSPtGA consists in one question that evaluates how one patient ranked the severity of HS at the time of the routine visit.	From Week 0 (baseline) to Week 52
Proportion of participants achieving clinical response using the Hidradenitis Suppurativa Clinical Response measure (HiSCR) at week 52	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 52
Change from Baseline in Health Utility Index Mark 3 (HUI3)	This is a comprehensive system for measuring health status and health-related quality of life and for producing utility scores.	From Week 0 (baseline) to Week 52
Change from Baseline in Female Sexual Function Index (FSFI)	The FSFI questionnaire contains 19 questions that describe the female sexual function in 6 domains. The domains are: desire, arousal, lubrication, orgasm, satisfaction, and pain, which can both be evaluated individually and in their entirety.	From Week 0 (baseline) to Week 52
Proportion of participants who experience worsening of HS by >= 1 Hurley Stage in >= 1 affected anatomic region	This will be done by evaluating the Hurley Stage using the following description: Stage I: Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring). Stage II: One or more widely separated recurrent abscesses with tract formation and cicatrization (scars). Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement.	Up to Week 52
Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA)	The HSSA questionnaire includes 9 questions that evaluate the symptoms an HS participant may experience associated with HS.	From Week 0 (baseline) to Week 52
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)	The HSIA questionnaire includes 18 questions that evaluate the impacts an HS participant may experience associated with HS.	From Week 0 (baseline) to Week 52
Change from Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem V2.0 (WPAI: SHP)	The WPAI: SHP evaluates four areas: percent work time missed due to HS, percent impairment while working due to HS, percent overall work impairment due to HS, and percent activity impairment due to HS.	From Week 0 (baseline) to Week 52
Number of days where participants experience HS flare-up	It is calculated from the day when flare is observed to the day prior to the observation that flare is no longer present. Of note, there could be multiple periods that flares are observed, in which case, the total days from the multiple periods will be used.	Up to Week 52

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2016
• Primary Completion (Actual): April 29, 2019
• Study Completion (Actual): April 29, 2019

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Canada; Humira®; Hidradenitis Suppurativa (HS)
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: P15-696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No