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

Hidradenitis Suppurativa (HS) Clinical Trial

— SOLACE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896920
• Other study ID #: P15-696
• Status: Completed
• Start date: September 20, 2016
• Est. completion date: April 29, 2019

Study information

• Verified date: April 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: April 29, 2019
• Est. primary completion date: April 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa
• Hidradenitis Suppurativa (HS)

Locations

Country	Name	City	State
Canada	SimcoMed Health Ltd /ID# 152445	Barrie	Ontario
Canada	Jason Ronald Sneath Medical Co /ID# 152462	Brandon	Manitoba
Canada	Institute for Skin Advancement /ID# 152448	Calgary	Alberta
Canada	Dr. Isabelle Delorme Inc. /ID# 152408	Drummondville	Quebec
Canada	Alberta DermaSurgery Centre /ID# 153834	Edmonton	Alberta
Canada	Dr. Irina Turchin PC Inc. /ID# 152464	Fredericton	New Brunswick
Canada	Eastern Canada Cutaneous Resea /ID# 153832	Halifax	Nova Scotia
Canada	Clinique D /ID# 152406	Laval	Quebec
Canada	Dr. Wei Jing Loo Medicine Prof /ID# 157923	London	Ontario
Canada	Lynderm Research Inc. /ID# 152436	Markham	Ontario
Canada	SKIN Centre for Dermatology /ID# 152457	Peterborough	Ontario
Canada	Hopital St-Sacrement /ID# 152456	Quebec
Canada	York Dermatology Center /ID# 152403	Richmond Hill	Ontario
Canada	Dre. Angelique Gagne-Henley /ID# 152611	St-Jerome	Quebec
Canada	Dr. Brown-Maher PMC INC. /ID# 152407	St. John's	Newfoundland and Labrador
Canada	Karma Clinical Trials /ID# 152444	St. John's	Newfoundland and Labrador
Canada	NewLab Clinical Research Inc. /ID# 152438	St. John's	Newfoundland and Labrador
Canada	Niakosari Medicine Professional Corporation /ID# 157851	Toronto	Ontario
Canada	Dermatologie Sima Inc. /ID# 152443	Verdun	Quebec
Canada	K. Papp Clinical Research /ID# 152446	Waterloo	Ontario
Canada	Winnipeg Clinic, Manitoba, CA /ID# 153830	Winnipeg	Manitoba
Canada	Wiseman Dermatology Research /ID# 153835	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   clinical study report synopsis