An observational study in Hidradenitis Suppurativa (HS), sponsored by AbbVie. Completed at 22 sites in Canada. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-05-01.
Sponsored by AbbVie · Observational
This study assesses Humira's® real-life effectiveness in the management of dermatological manifestations of moderate to severe Hidradenitis Suppurativa (HS).
277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
This study's enrollment of 165 is above the median of 142 across 69 observational studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with moderate or severe HS
Exclusion Criteria:
Participants with HS for whom a change in treatment to Humira® is made by the treating physician
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
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.
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
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 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
Plan to share: Undecided
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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