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

AbbVie165 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

165

Conditions

Hidradenitis Suppurativa (HS)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (22)

Institute for Skin Advancement /ID# 152448

Calgary, Alberta, Canada

Outcomes

Primary Outcomes

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.

Time frame: At Week 24

Secondary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Alberta DermaSurgery Centre /ID# 153834

Edmonton, Alberta, Canada

Jason Ronald Sneath Medical Co /ID# 152462

Brandon, Manitoba, Canada

Winnipeg Clinic, Manitoba, CA /ID# 153830

Winnipeg, Manitoba, Canada

Wiseman Dermatology Research /ID# 153835

Winnipeg, Manitoba, Canada

Dr. Irina Turchin PC Inc. /ID# 152464

Fredericton, New Brunswick, 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

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

St. John's, Newfoundland and Labrador, Canada

Eastern Canada Cutaneous Resea /ID# 153832

Halifax, Nova Scotia, Canada

...and 12 more locations

Time frame: From Week 0 (baseline) to Week 52

Proportion of participants achieving clinical response using the Hidradenitis Suppurativa Clinical Response measure (HiSCR) at week 52

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to Week 52