Real-world Secukinumab Outcomes in Canadian HS Patients
ConditionHidradenitis Suppurativa
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must give written, signed, and dated informed consent before any information is collected and any study-related activity is performed.
Adult patients at the time of informed consent signature.
Patients with the diagnosis of moderate-to-severe HS, as determined by the dermatologist.
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.
Disqualifiers
Any medical or psychological condition in the treating physician's opinion that may prevent the patient from study participation.
Patients who have any contraindications to treatment with secukinumab, as defined in the Canadian PM.
Patients who have had any prior exposure to secukinumab (i.e., >7 days prior to the baseline visit).
Trial population
Canadian patients diagnosed with moderate-to-severe HS and treated with secukinumab as per routine clinical practice
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
142 Participants
are grouped into 1 trial groupGroup A: Secukinumab
Trial outcomes
Primary outcomes
1
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 12Secondary outcomes
1
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 62
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 123
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 124
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 12Sponsors and contacts
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Source ClinicalTrials.gov