Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-02 @ 6:29 AM
Study NCT ID:
NCT06517732
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2024-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555450', 'term': 'secukinumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2024-07-18', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)', 'timeFrame': '12 months', 'description': 'The International Hidradenitis Suppurativa Severity Scoring System (IHS4) allows for a dynamic assessment of the disease severity both in clinical studies and in real-world clinical setting. The IHS4 is determined by counting nodules, abscesses, and draining tunnels (fistulae/sinuses). IHS4 (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + \\[number of draining tunnels (fistulae/sinuses) multiplied by 4\\]. A score of 3 or lower indicates a mild stage of hidradenitis suppurativa, a score of 4-10 indicates a moderate stage, and a score of 11 or higher indicates a severe stage of the disease. The IHS4 severity scoring system assumes that the presence of a draining tunnel (fistula/sinus) is sufficient to classify a case as at least moderate.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab', 'timeFrame': '12 months', 'description': 'Proportion of patients receiving Hidradenitis Suppurativa (HS)-specific concomitant treatments in combination with secukinumab'}, {'measure': 'Time of initiation of concomitant medication', 'timeFrame': '12 months', 'description': 'Time of initiation of concomitant medication (before or after the initiation of secukinumab).'}, {'measure': 'Duration of treatment with concomitant medication', 'timeFrame': '12 months', 'description': 'Duration of treatment with concomitant medication of secukinumab'}, {'measure': 'Number, type, and outcome of surgical interventions', 'timeFrame': '12 months', 'description': 'Number, type, and outcome of surgical interventions (minor and major surgical excision; inpatient, outpatient, or self-treatment at home)'}, {'measure': 'Timepoint of and reason for surgical intervention', 'timeFrame': '12 months', 'description': 'Timepoint of and reason for surgical intervention.'}, {'measure': 'Duration of discontinuation/pause of secukinumab treatment before surgery', 'timeFrame': '12 months', 'description': 'Duration of discontinuation/pause of secukinumab treatment before surgery'}, {'measure': 'Duration of discontinuation/pause of secukinumab treatment after surgery', 'timeFrame': '12 months', 'description': 'Duration of discontinuation/pause of secukinumab treatment after surgery'}, {'measure': 'Surgery outcome', 'timeFrame': '12 months', 'description': 'Surgery outcome by type of wound healing, pain relief and discontinuation or continuation of secukinumab.'}, {'measure': 'Outcome of surgery and adverse events stratified by secukinumab management', 'timeFrame': '12 months', 'description': 'Outcome of surgery (healing, pain relief) and adverse events (i.e., infections) stratified by secukinumab management (continuation or discontinuation).'}, {'measure': 'Predictors of treatment response', 'timeFrame': '12 months', 'description': 'Listing of predictors of treatment response'}, {'measure': 'Proportion of patients achieving 75% reduction in IHS4 (IHS4-75) and 100% reduction in IHS4 (IHS4-100)', 'timeFrame': 'Month 6, month 12', 'description': 'The International Hidradenitis Suppurativa Severity Scoring System (IHS4) allows for a dynamic assessment of the disease severity both in clinical studies and in real-world clinical setting. The IHS4 is determined by counting nodules, abscesses, and draining tunnels (fistulae/sinuses). IHS4 (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + \\[number of draining tunnels (fistulae/sinuses) multiplied by 4\\]. A score of 3 or lower indicates a mild stage of hidradenitis suppurativa, a score of 4-10 indicates a moderate stage, and a score of 11 or higher indicates a severe stage of the disease. The IHS4 severity scoring system assumes that the presence of a draining tunnel (fistula/sinus) is sufficient to classify a case as at least moderate.'}, {'measure': 'Lesion spread', 'timeFrame': 'Baseline, month 6, month 12', 'description': 'Lesion spread (defined as total abscess and inflammatory nodule count (AN) or draining fistula in a body region not seen at baseline) assessed by number, type, and localization of HS lesions'}, {'measure': 'Mean change of nodule count', 'timeFrame': 'Month 6, month 12', 'description': 'Mean reduction of nodule count'}]}, 'conditionsModule': {'keywords': ['Hidradenitis Suppurativa', 'HS', 'real-world data', 'secukinumab'], 'conditions': ['Hidradenitis Suppurativa']}, 'descriptionModule': {'briefSummary': 'ANIMA-R is an observational, prospective, non-interventional, multicenter study to assess real-world effectiveness of secukinumab in the treatment of Hidradenitis Suppurativa (HS).', 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with moderate to severe Hidradenitis Suppurativa commencing treatment with secukinumab', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients who provide written informed consent form (ICF) to participate in the study.\n2. Male and female.\n3. ≥ 18 years old.\n4. Diagnosis of moderate or severe HS (Hurley stage and IHS4).\n5. Patient who initiated treatment with secukinumab no longer than 4 weeks prior to written ICF.\n6. Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of study participation.\n\nExclusion Criteria:\n\n1. Any medical or psychological condition that may prevent the study participation, based on practitioners' decision-making.\n2. Participation in an ongoing clinical trial.\n3. Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).\n4. Clinically significant infection exacerbation, including active tuberculosis.\n5. Patients with active inflammatory bowel disease (IBD).\n6. Age \\<18 years.\n7. Pregnancy and breastfeeding.\n8. Patients who received any vaccine within 4 weeks prior to secukinumab initiation."}, 'identificationModule': {'nctId': 'NCT06517732', 'acronym': 'ANIMA-R', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'CAIN457MRU01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Secukinumab', 'description': 'Patients prescribed with secukinumab in the treatment of Hidradenitis Suppurativa', 'interventionNames': ['Other: Secukinumab']}], 'interventions': [{'name': 'Secukinumab', 'type': 'OTHER', 'description': 'This is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.', 'armGroupLabels': ['Secukinumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '426039', 'city': 'Izhevsk', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 56.85225, 'lon': 53.19862}}, {'zip': '236016', 'city': 'Kaliningrad', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.70639, 'lon': 20.51102}}, {'zip': '236029', 'city': 'Kaliningrad', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.70639, 'lon': 20.51102}}, {'zip': '420012', 'city': "Kazan'", 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '650025', 'city': 'Kemerovo', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '350020', 'city': 'Krasnodar', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}, {'zip': '107076', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119049', 'city': 'Moscow', 'status': 'WITHDRAWN', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119881', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '123182', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129110', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603950', 'city': 'Nizhny Novgorod', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '440052', 'city': 'Penza', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.19568, 'lon': 45.01075}}, {'zip': '197022', 'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443079', 'city': 'Samara', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '410028', 'city': 'Saratov', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '355020', 'city': 'Stavropol', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.03442, 'lon': 41.9642}}, {'zip': '300053', 'city': 'Tula', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.19609, 'lon': 37.61822}}, {'zip': '450010', 'city': 'Ufa', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'zip': '677000', 'city': 'Yakutsk', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 62.03114, 'lon': 129.72288}}], 'centralContacts': [{'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'email': 'novartis.email@novartis.com', 'phone': '+41613241111'}, {'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}