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This study assesses Humira's® real-life effectiveness in the management of dermatological manifestations of moderate to severe Hidradenitis Suppurativa (HS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving adalimumab/ Humira® | Participants with HS for whom a change in treatment to Humira® is made by the treating physician |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with moderate or severe HS
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Skin Advancement /ID# 152448 | Calgary | Alberta | T3A 2N1 | Canada | ||
| Alberta DermaSurgery Centre /ID# 153834 |
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| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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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 |
| 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 |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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