Hidradenitis Suppurativa (HS)SOLACENCT02896920
Canadian Humira Post Marketing Observational Epidemiological Study : Assessing Humira Real-life Effectiveness and Impact on HS Burden of Illness
An observational study of Hidradenitis Suppurativa (HS), run by AbbVie at 22 sites in Canada.
Trial summary
This study assesses Humira's® real-life effectiveness in the management of dermatological manifestations of moderate to severe Hidradenitis Suppurativa (HS). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- How many people
- 165 participants
- Where
- 22 sitesCanada
- Study dates
- 20 Sep 2016to 29 Apr 2019
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with moderate or severe HS
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Canada22 sites
SimcoMed Health Ltd /ID# 152445
Barrie, Ontario, L4M 7G1
Jason Ronald Sneath Medical Co /ID# 152462
Brandon, Manitoba, R7A 0L5
Institute for Skin Advancement /ID# 152448
Calgary, Alberta, T3A 2N1
Dr. Isabelle Delorme Inc. /ID# 152408
Drummondville, Quebec, J2B 5L4
Alberta DermaSurgery Centre /ID# 153834
Edmonton, Alberta, T6G 1C3
Dr. Irina Turchin PC Inc. /ID# 152464
Fredericton, New Brunswick, E3B 1G9
Eastern Canada Cutaneous Resea /ID# 153832
Halifax, Nova Scotia, B3H 1Z2
Clinique D /ID# 152406
Laval, Quebec, H7N 6L2
Dr. Wei Jing Loo Medicine Prof /ID# 157923
London, Ontario, N6H 5L5
Lynderm Research Inc. /ID# 152436
Markham, Ontario, L3P 1X2
SKIN Centre for Dermatology /ID# 152457
Peterborough, Ontario, K9J 5K2
Hopital St-Sacrement /ID# 152456
Québec, M5C1R6
York Dermatology Center /ID# 152403
Richmond Hill, Ontario, L4C 9M7
Dre. Angelique Gagne-Henley /ID# 152611
Saint-Jérôme, Quebec, J7Z 7E2
Karma Clinical Trials /ID# 152444
St. John's, Newfoundland and Labrador, A1A 4Y3
NewLab Clinical Research Inc. /ID# 152438
St. John's, Newfoundland and Labrador, A1C 2H5
Dr. Brown-Maher PMC INC. /ID# 152407
St. John's, Newfoundland and Labrador, A1E 1V4
Niakosari Medicine Professional Corporation /ID# 157851
Toronto, Ontario, M2M 4J5
Dermatologie Sima Inc. /ID# 152443
Verdun, Quebec, H4G 3E7
K. Papp Clinical Research /ID# 152446
Waterloo, Ontario, N2J 1C4
Winnipeg Clinic, Manitoba, CA /ID# 153830
Winnipeg, Manitoba, R3C 1T6
Wiseman Dermatology Research /ID# 153835
Winnipeg, Manitoba, R3M 3Z4
About this study
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
This study assesses Humira's® real-life effectiveness in the management of dermatological manifestations of moderate to severe Hidradenitis Suppurativa (HS).
- Conditions
- Hidradenitis Suppurativa (HS)
- Keywords
- Hidradenitis Suppurativa (HS), Humira®, Canada
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving adalimumab/ Humira® | Participants with HS for whom a change in treatment to Humira® is made by the treating physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 24
Secondary outcomes (13)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start20 Sep 2016
- Primary completion29 Apr 2019
- Study completion29 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896920
- Sponsor's protocol ID
- P15-696
- Acronym
- SOLACE
- Status last verified
- Apr 2020
- First submitted
- 7 Sep 2016
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided