SOLACE: Canadian Humira Post Marketing Observational Epidemiological Study : Assessing Humira Real-life Effectiveness and Impact on HS Burden of Illness
Study Details
Study Description
Brief Summary
This study assesses Humira's® real-life effectiveness in the management of dermatological manifestations of moderate to severe Hidradenitis Suppurativa (HS).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants receiving adalimumab/ Humira® Participants with HS for whom a change in treatment to Humira® is made by the treating physician |
Outcome Measures
Primary Outcome Measures
- Proportion of participants achieving clinical response using the Hidradenitis Suppurativa Clinical Response measure (HiSCR) at week 24 [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.
Secondary Outcome Measures
- Proportion of participants who experience flare [Up to Week 52]
It is defined as at least 25% increase in AN counts with a minimum increase of 2 relative to baseline
- Change from Baseline in Hospital Anxiety and Depression Scale (HADS) [From Week 0 (baseline) to Week 52]
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.
- Change from Baseline in International Index of Erectile Function (IIEF) [From Week 0 (baseline) to Week 52]
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.
- Change from Baseline in Health Care Resource Utilization (HCRU) associated with HS [From Week 0 (baseline) to Week 52]
This will be assessed using a descriptive questionnaire that aimed at measuring the patient's health care resource utilization and economic impact of HS.
- Change from Baseline in Patient Global Assessment of HS (HS-PtGA) [From Week 0 (baseline) to Week 52]
The HSPtGA consists in one question that evaluates how one patient ranked the severity of HS at the time of the routine visit.
- Proportion of participants achieving clinical response using the Hidradenitis Suppurativa Clinical Response measure (HiSCR) at week 52 [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.
- Change from Baseline in Health Utility Index Mark 3 (HUI3) [From Week 0 (baseline) to Week 52]
This is a comprehensive system for measuring health status and health-related quality of life and for producing utility scores.
- Change from Baseline in Female Sexual Function Index (FSFI) [From Week 0 (baseline) to Week 52]
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.
- Proportion of participants who experience worsening of HS by >= 1 Hurley Stage in >= 1 affected anatomic region [Up to Week 52]
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.
- Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA) [From Week 0 (baseline) to Week 52]
The HSSA questionnaire includes 9 questions that evaluate the symptoms an HS participant may experience associated with HS.
- Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA) [From Week 0 (baseline) to Week 52]
The HSIA questionnaire includes 18 questions that evaluate the impacts an HS participant may experience associated with HS.
- Change from Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem V2.0 (WPAI: SHP) [From Week 0 (baseline) to Week 52]
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.
- Number of days where participants experience HS flare-up [Up to Week 52]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Has a clinical diagnosis of moderate to severe HS according to the treating physician judgment
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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.
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Has provided written informed consent (Patient Authorization) for participation in the study
Exclusion Criteria:
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Is participating in a clinical interventional study
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Was treated with Humira®, or any other biologic agents for HS prior to baseline visit
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute for Skin Advancement /ID# 152448 | Calgary | Alberta | Canada | T3A 2N1 |
| 2 | Alberta DermaSurgery Centre /ID# 153834 | Edmonton | Alberta | Canada | T6G 1C3 |
| 3 | Jason Ronald Sneath Medical Co /ID# 152462 | Brandon | Manitoba | Canada | R7A 0L5 |
| 4 | Winnipeg Clinic, Manitoba, CA /ID# 153830 | Winnipeg | Manitoba | Canada | R3C 1T6 |
| 5 | Wiseman Dermatology Research /ID# 153835 | Winnipeg | Manitoba | Canada | R3M 3Z4 |
| 6 | Dr. Irina Turchin PC Inc. /ID# 152464 | Fredericton | New Brunswick | Canada | E3B 1G9 |
| 7 | Karma Clinical Trials /ID# 152444 | St. John's | Newfoundland and Labrador | Canada | A1A 4Y3 |
| 8 | NewLab Clinical Research Inc. /ID# 152438 | St. John's | Newfoundland and Labrador | Canada | A1C 2H5 |
| 9 | Dr. Brown-Maher PMC INC. /ID# 152407 | St. John's | Newfoundland and Labrador | Canada | A1E 1V4 |
| 10 | Eastern Canada Cutaneous Resea /ID# 153832 | Halifax | Nova Scotia | Canada | B3H 1Z2 |
| 11 | SimcoMed Health Ltd /ID# 152445 | Barrie | Ontario | Canada | L4M 7G1 |
| 12 | Dr. Wei Jing Loo Medicine Prof /ID# 157923 | London | Ontario | Canada | N6H 5L5 |
| 13 | Lynderm Research Inc. /ID# 152436 | Markham | Ontario | Canada | L3P 1X2 |
| 14 | SKIN Centre for Dermatology /ID# 152457 | Peterborough | Ontario | Canada | K9J 5K2 |
| 15 | York Dermatology Center /ID# 152403 | Richmond Hill | Ontario | Canada | L4C 9M7 |
| 16 | Niakosari Medicine Professional Corporation /ID# 157851 | Toronto | Ontario | Canada | M2M 4J5 |
| 17 | K. Papp Clinical Research /ID# 152446 | Waterloo | Ontario | Canada | N2J 1C4 |
| 18 | Dr. Isabelle Delorme Inc. /ID# 152408 | Drummondville | Quebec | Canada | J2B 5L4 |
| 19 | Clinique D /ID# 152406 | Laval | Quebec | Canada | H7N 6L2 |
| 20 | Dre. Angelique Gagne-Henley /ID# 152611 | St-Jerome | Quebec | Canada | J7Z 7E2 |
| 21 | Dermatologie Sima Inc. /ID# 152443 | Verdun | Quebec | Canada | H4G 3E7 |
| 22 | Hopital St-Sacrement /ID# 152456 | Quebec | Canada | M5C1R6 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- P15-696