Real-world Secukinumab Outcomes in Canadian HS Patients

N/ARecruitingNCT07282015

Novartis Pharmaceuticals142 enrolled

Overview

The HS-RISE study aims to assess real-world HS treatment outcomes and patterns, safety of secukinumab, and to describe the baseline characteristics of patients diagnosed with moderate-to- severe HS who are prescribed secukinumab in Canadian routine clinical practice.

Study Type

OBSERVATIONAL

Enrollment

142

Conditions

Hidradenitis Suppurativa

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients must give written, signed, and dated informed consent before any information is collected and any study-related activity is performed. 2. Adult patients at the time of informed consent signature. 3. Patients with the diagnosis of moderate-to-severe HS, as determined by the dermatologist. 4. Patients who have been newly prescribed secukinumab as part of routine clinical care according to the approved Canadian PM. The decision to prescribe secukinumab must be made prior to,and independent of, study participation. First treatment with secukinumab must occur no more than 7 days (≤7 days) prior to Baseline visit. 5. Patients who can understand written and spoken Canadian English or French. Exclusion Criteria: 1. Any medical or psychological condition in the treating physician's opinion that may prevent the patient from study participation. 2. Patients who have any contraindications to treatment with secukinumab, as defined in the Canadian PM. 3. Patients who have had any prior exposure to secukinumab (i.e., \>7 days prior to the baseline visit).

Locations (11)

Novartis Investigative Site

Calgary, Alberta, Canada

RECRUITING

Novartis Investigative Site

Winnipeg, Manitoba, Canada

RECRUITING

Outcomes

Primary Outcomes

Proportion of patients who experience a change in disease severity classification

Proportion of patients who experience a change in disease severity classification from baseline to 12 months, as determined by the International HS Severity Score System (IHS4). Determining IHS4 score requires counting nodules, abscesses and draining tunnels/sinus tracts. A score of 3 or less signifies mild HS, a score of 4 to 10 signifies moderate HS, and a score of 11 or higher signifies severe HS.

Time frame: Baseline, month 12

Secondary Outcomes

Proportion of patients overall who experience a change in disease severity classification

Proportion of patients overall who experience a change in disease severity classification as determined by IHS4 from baseline at Months 3 and 6; additional subgroups analyses by ethnicity/race. Determining IHS4 score requires counting nodules, abscesses and draining tunnels/sinus tracts. A score of 3 or less signifies mild HS, a score of 4 to 10 signifies moderate HS, and a score of 11 or higher signifies severe HS.

Time frame: Baseline, Month 3, Month 6

Proportion of patients achieving a 55% reduction in International HS Severity Score System (IHS4-55)

Proportion of patients achieving IHS4-55 at Months 3, 6, and 12; additional subgroups analyses by ethnicity/race. IHS4-55 is defined as at least a 55% reduction in their IHS4 from baseline.

Time frame: Baseline, Month 3, Month 6, Month 12

Proportion of patients experiencing HS Clinical Response 50 (HiSCRO50)

Proportion of patients achieving a 50% reduction from baseline in HS Clinical Response Score (HiSCR50) at Months 3, 6, and 12; additional subgroups analyses by ethnicity/race. HiSCR50 is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase from baseline in abscesses or draining fistulae count.

Time frame: Baseline, Month 3, Month 6, Month 12

Central Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

novartis.email@novartis.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Novartis Investigative Site

Cobourg, Ontario, Canada

RECRUITING

Novartis Investigative Site

Hamilton, Ontario, Canada

RECRUITING

Novartis Investigative Site

London, Ontario, Canada

RECRUITING

Novartis Investigative Site

Markham, Ontario, Canada

RECRUITING

Novartis Investigative Site

Mississauga, Ontario, Canada

RECRUITING

Novartis Investigative Site

Richmond Hill, Ontario, Canada

RECRUITING

Novartis Investigative Site

Toronto, Ontario, Canada

RECRUITING

Novartis Investigative Site

Saint-Jérôme, Quebec, Canada

RECRUITING

...and 1 more locations

Mean reduction in abscess and inflammatory nodule count

Mean reduction in abscess and inflammatory nodule count from baseline at Months 3, 6, and 12; additional subgroups analyses by ethnicity/race

Time frame: Baseline, Month 3, Month 6, Month 12

Descriptive summaries of demographic and clinical variables

Descriptive summaries demographic and clinical variables

Time frame: Baseline

Proportion of patients receiving secukinumab up-titration from every 4 weeks (Q4W) to every 2 weeks (Q2W)

Proportion of patients receiving secukinumab up-titration from Q4W to Q2W at Months 3, 6, and 12; Subgroup analysis by ethnicity/race as well as time to biologic treatment initiation

Time frame: Month 3, Month 6, Month 12

Proportion of patients receiving secukinumab down-titration from every 2 weeks (Q2W) to every 4 weeks (Q4W)

Proportion of patients receiving secukinumab down-titration from Q2W to Q4W at Months 3, 6, and 12; Subgroup analysis by ethnicity/race as well as time to biologic treatment initiation

Time frame: Month 3, Month 6, Month 12

Time to secukinumab up- and down-titration

Time frame: Month 3, Month 6, Month 12

Proportion of patients experiencing adverse events post-secukinumab initiation

Time frame: Up to 12 Months

Proportion of patients experiencing serious adverse events post-secukinumab initiation

Time frame: Up to 12 Months

Type of adverse events and serious adverse events experienced by patients post-secukinumab initiation

Time frame: Up to 12 Months

Proportion of patients who discontinued secukinumab due to adverse events

Time frame: Up to 12 Months

Proportion of patients receiving additional HS-related therapies

Proportion of patients receiving additional HS-related therapies at Months 3, 6, and 12; additional subgroup analysis by dosing, ethnicity/race and time to biologic initiation

Time frame: Month 3, Month 6, Month 12

Proportion of patients requiring unplanned surgeries

Proportion of patients requiring unplanned surgeries at Month 3, 6, and 12; additional subgroup analysis by dosing, ethnicity/race and time to biologic initiation

Time frame: Month 3, Month 6, Month 12

Proportion of patients discontinuing secukinumab treatment

Proportion of patients discontinuing secukinumab treatment at Months 3, 6, and 12; additional sugbroup analyses also done by ethnicity/race

Time frame: Month 3, Month 6, Month 12

Reason(s) for secukinumab discontinuation

Reason(s) for secukinumab discontinuation; additional subgroup analyses by ethnicity/race

Time frame: Up to 12 Months

Percentage of no-show appointments which were scheduled as per standard of care

Percentage of no-show appointments which were scheduled as per standard of care with participating dermatologist (including injections) and the corresponding reason(s); additional subgroup analyses by ethnicity/race

Time frame: Up to 12 Months