Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 6:42 AM
Study NCT ID:
NCT05663268
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2022-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa
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': 'C000591237', 'term': 'CT-P13'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Adult patients of either gender suffering from Hidradenitis suppurativa resistant to conventional therapies'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-26', 'studyFirstSubmitDate': '2022-12-15', 'studyFirstSubmitQcDate': '2022-12-22', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hidradenitis Suppurativa Clinical Response (HiSCR)', 'timeFrame': '24 weeks', 'description': '50% reduction in score'}, {'measure': 'Dermatology Life Quality Index (DLQI)', 'timeFrame': '24 weeks', 'description': '50% reduction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hidradenitis suppurativa', 'Infliximab biosimilar', 'Efficacy', 'safety'], 'conditions': ['Hidradenitis Suppurativa']}, 'referencesModule': {'references': [{'pmid': '17587838', 'type': 'RESULT', 'citation': 'Fernandez-Vozmediano JM, Armario-Hita JC. Infliximab for the treatment of hidradenitis suppurativa. Dermatology. 2007;215(1):41-4. doi: 10.1159/000102032.'}, {'pmid': '14632813', 'type': 'RESULT', 'citation': 'Sullivan TP, Welsh E, Kerdel FA, Burdick AE, Kirsner RS. Infliximab for hidradenitis suppurativa. Br J Dermatol. 2003 Nov;149(5):1046-9. doi: 10.1111/j.1365-2133.2003.05663.x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to assess the efficacy and safety of Infliximab-dyyb biosimilar in patients of resistant Hidradenitis suppurativa. The main question it aims to answer are:\n\n* how effective is infliximab biosimilar in treating resistant Hidradentis suppurativa\n* Is infliximab biosimilar safe in these patients Patients will receive weekly injections of Infliximab Biosimilar Remsima, according to weight, for first 4 weeks, and then fortnightly for next 24 weeks. Patients will be followed up at 4, 14 and 24 weeks for assessment of safety and efficacy', 'detailedDescription': 'The aim of this clinical trial is to assess the efficacy and safety of Infliximab-dyyb biosimilar in patients of resistant Hidradenitis suppurativa. The main question it aims to answer are:\n\n* how effective is infliximab biosimilar in treating resistant Hidradentis suppurativa\n* Is infliximab biosimilar safe in these patients Patients will receive weekly injections of Infliximab Biosimilar Remsima, according to weight, for first 4 weeks, and then fortnightly for next 24 weeks. Patients will be followed up at 4, 14 and 24 weeks for assessment of safety and efficacy.\n\nPre and post treatment HiSCR, IHS4, DLQI scores and photos will be taken for comparison at week 0, 4, 14 and 24. Details will be entered on predesigned proforma DATA ANALYSIS PROCEDURE: Data will be entered and analyzed using SPSS 20. Data will be stratified for role of effect modifiers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of Hidradenitis suppurativa resistant to conventional therapy\n\nExclusion Criteria:\n\n* Immunocompromised patients\n* Patients with connective tissue disorders\n* patients having chronic infections like heapatitis, HIV or Tuberculosis\n* Pregnant or lactating mothers\n* hypersensitivity to biologics'}, 'identificationModule': {'nctId': 'NCT05663268', 'briefTitle': 'Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Services Institute of Medical Sciences, Pakistan'}, 'officialTitle': 'Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa', 'orgStudyIdInfo': {'id': 'IRB/2022/101/SIMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients of Hidradenitis suppurativa resistant to conventional therapy', 'description': 'injection Infliximab-dyyb biosimilar (according to weight, single injection of 120mg if weight \\<80kg, 2 injections if weight \\> 80kg) will be injected subcutaneously at week 0,1, 2,3,4, and then fortnightly till 24 weeks.', 'interventionNames': ['Biological: Infliximab-dyyb biosimilar']}], 'interventions': [{'name': 'Infliximab-dyyb biosimilar', 'type': 'BIOLOGICAL', 'otherNames': ['Remsima (infliximab-dyyb biosimilar)'], 'description': 'Remsima for subcutaneous injection is a biosimilar monoclonal antibody of infliximab-dyyb that inhibits the activity of tumour necrosis factor (TNF)-alpha.', 'armGroupLabels': ['Patients of Hidradenitis suppurativa resistant to conventional therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Services Institute of Medical Sciences', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Hira Tariq, FCPS Derma', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Services Institute of Medical Sciences, Pakistan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Services Institute of Medical Sciences, Pakistan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hira Tariq', 'investigatorAffiliation': 'Services Institute of Medical Sciences, Pakistan'}}}}