Canadian Humira Post Marketing Observational Epidemiological Study : Assessing Humira Real-life Effectiveness and Impact on HS Burden of Illness (SOLACE)
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| ClinicalTrials.gov Identifier: NCT02896920 |
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Recruitment Status :
Completed
First Posted : September 12, 2016
Last Update Posted : May 1, 2020
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Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
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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 |
|---|
| Hidradenitis Suppurativa (HS) |
| Study Type : | Observational |
| Actual Enrollment : | 165 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 |
| Actual Study Start Date : | September 20, 2016 |
| Actual Primary Completion Date : | April 29, 2019 |
| Actual Study Completion Date : | April 29, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hidradenitis suppurativa
MedlinePlus related topics:
Hidradenitis Suppurativa
Drug Information available for:
Adalimumab
| Group/Cohort |
|---|
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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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Primary Outcome Measures :
- Proportion of participants achieving clinical response using the Hidradenitis Suppurativa Clinical Response measure (HiSCR) at week 24 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Participants with moderate or severe HS
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896920
Locations
Show 22 study locations
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | AbbVie Inc. | AbbVie |
Additional Information:
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT02896920 |
| Other Study ID Numbers: |
P15-696 |
| First Posted: | September 12, 2016 Key Record Dates |
| Last Update Posted: | May 1, 2020 |
| Last Verified: | April 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by AbbVie:
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Hidradenitis Suppurativa (HS) Humira® Canada |
Additional relevant MeSH terms:
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Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial |
Bacterial Infections Bacterial Infections and Mycoses Infections Skin Diseases, Infectious Suppuration |