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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
Recruitment Status : Active, not recruiting
First Posted : September 12, 2016
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab
U.S. FDA Resources

Group/Cohort
Participants receiving adalimumab/ Humira®
Participants with HS for whom a change in treatment to Humira® is made by the treating physician



Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.


  10. 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.

  11. 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.

  12. 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.

  13. 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, Senior)
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
Canada, Alberta
Institute for Skin Advancement
Calgary, Alberta, Canada, T3A 2N1
Alberta DermaSurgery Centre
Edmonton, Alberta, Canada, T6G 1C3
Searles Derm & Aesthetics
Edmonton, Alberta, Canada, T6J 5E5
Canada, British Columbia
Dr. Lorne E. Albrecht Inc.
Surrey, British Columbia, Canada, V3V 0C6
Dr. Allison Sutton Inc
Vancouver, British Columbia, Canada, V5Z 3Y1
Canada, Manitoba
Jason Ronald Sneath Medical Co
Brandon, Manitoba, Canada, R7A 0L5
Winnipeg Clinic, Manitoba, CA
Winnipeg, Manitoba, Canada, R3C 1T6
Wiseman Dermatology Research
Winnipeg, Manitoba, Canada, R3M 3Z4
Canada, New Brunswick
Dr. Irina Turchin PC Inc.
Fredericton, New Brunswick, Canada, E3B 1G9
Canada, Newfoundland and Labrador
Karma Clinical Trials
St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
NewLab Clinical Research Inc.
St. John's, Newfoundland and Labrador, Canada, A1C 2H5
Dr. Brown-Maher PMC INC.
St. John's, Newfoundland and Labrador, Canada, A1E 1V4
Canada, Nova Scotia
Eastern Canada Cutaneous Resea
Halifax, Nova Scotia, Canada, B3H 0A2
Canada, Ontario
SimcoMed Health Ltd
Barrie, Ontario, Canada, L4M 7G1
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Dr. Wei Jing Loo Medicine Prof
London, Ontario, Canada, N6H 5L5
Lynderm Research Inc.
Markham, Ontario, Canada, L3P 1X2
Toronto Regional Wound Healing
Mississauga, Ontario, Canada, L4Y 1A6
SKIN Centre for Dermatology
Peterborough, Ontario, Canada, K9J 5K2
York Dermatology Center
Richmond Hill, Ontario, Canada, L4C 9M7
Dr. Niakosari Medicine Profess
Toronto, Ontario, Canada, M2 M4J5
K. Papp Clinical Research
Waterloo, Ontario, Canada, N2J 1C4
Canada, Quebec
Dr. Isabelle Delorme Inc.
Drummondville, Quebec, Canada, J2B 5L4
Clinique D
Laval, Quebec, Canada, H7N 6L2
Dre. Angelique Gagne-Henley
Montreal, Quebec, Canada, J7Z 3B8
Dermatologie Sima Inc.
Verdun, Quebec, Canada, H4G 3E7
Canada
Hopital St-Sacrement
Quebec, Canada, M5C1R6
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02896920     History of Changes
Other Study ID Numbers: P15-696
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
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:
Hidradenitis Suppurativa (HS)
Humira®
Canada

Additional relevant MeSH terms:
Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents