Clinical trial NCT06517732: Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) in Routine Clinical Practice in the Russian Federation
Official title: Prospective, Observational, Multicenter Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) in Routine Clinical Practice in the Russian Federation (ANIMA-R)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
HS
real-world data
secukinumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-07-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with moderate to severe Hidradenitis Suppurativa commencing treatment with secukinumab

Brief summary: ANIMA-R is an observational, prospective, non-interventional, multicenter study to assess real-world effectiveness of secukinumab in the treatment of Hidradenitis Suppurativa (HS).

Detailed description: The index date will be the date of secukinumab initiation. During the study, data will be collected from patients receiving routine secukinumab treatment, which is representative of the actual patient population.

The attending physician will decide whether to prescribe secukinumab based on the approved instructions for medical use in a routine clinical setting, regardless of the patient's participation in a non-interventional study.

Eligibility criteria: Inclusion Criteria:

1. Patients who provide written informed consent form (ICF) to participate in the study.
2. Male and female.
3. ≥ 18 years old.
4. Diagnosis of moderate or severe HS (Hurley stage and IHS4).
5. Patient who initiated treatment with secukinumab no longer than 4 weeks prior to written ICF.
6. Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of study participation.

Exclusion Criteria:

1. Any medical or psychological condition that may prevent the study participation, based on practitioners' decision-making.
2. Participation in an ongoing clinical trial.
3. Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
4. Clinically significant infection exacerbation, including active tuberculosis.
5. Patients with active inflammatory bowel disease (IBD).
6. Age \<18 years.
7. Pregnancy and breastfeeding.
8. Patients who received any vaccine within 4 weeks prior to secukinumab initiation.

Primary outcomes:
measure: Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab
timeFrame: 12 months
measure: Time of initiation of concomitant medication
timeFrame: 12 months
measure: Duration of treatment with concomitant medication
timeFrame: 12 months
measure: Number, type, and outcome of surgical interventions
timeFrame: 12 months
measure: Timepoint of and reason for surgical intervention
timeFrame: 12 months
measure: Duration of discontinuation/pause of secukinumab treatment before surgery
timeFrame: 12 months
measure: Duration of discontinuation/pause of secukinumab treatment after surgery
timeFrame: 12 months
measure: Surgery outcome
timeFrame: 12 months
measure: Outcome of surgery and adverse events stratified by secukinumab management
timeFrame: 12 months
measure: Predictors of treatment response
timeFrame: 12 months
measure: Proportion of patients achieving 75% reduction in IHS4 (IHS4-75) and 100% reduction in IHS4 (IHS4-100)
timeFrame: Month 6, month 12
measure: Lesion spread
timeFrame: Baseline, month 6, month 12
measure: Mean change of nodule count
timeFrame: Month 6, month 12
Other outcomes:
Locations:
city: Izhevsk
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Kemerovo
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Samara
country: Russian Federation
facility: Novartis Investigative Site
city: Stavropol
country: Russian Federation
facility: Novartis Investigative Site
city: Tula
country: Russian Federation
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: