Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2026-01-01 @ 6:49 PM
Study NCT ID:
NCT05320159
Status:
COMPLETED
Last Update Posted:
2022-07-01
First Post:
2022-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Effectiveness Among Psoriasis Patients Treated With Cosentyx (Secukinumab)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555450', 'term': 'secukinumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17743}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-29', 'studyFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2022-04-08', 'lastUpdatePostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment satisfaction level at Baseline', 'timeFrame': 'Baseline', 'description': 'Patient reported satisfaction with treatment effectiveness was captured on a 5-point scale - "I believe this treatment is effective in clearing my skin of psoriasis." (1 = strongly agree, 2 = somewhat agree, 3 = Neither agree nor disagree, 4 = Somewhat disagree, 5 = Strongly disagree; n, %) in the EMR data system.\n\nFor this analysis, the responses were classified into three groups:\n\n1. Satisfied with treatment effectiveness (1 = strongly agree, 2 = somewhat agree)\n2. Dissatisfied with treatment effectiveness ( 4 = Somewhat disagree, 5 = Strongly disagree)\n3. Neither satisfied nor dissatisfied with treatment effectiveness (3 = Neither agree nor disagree)'}, {'measure': 'Treatment satisfaction level at 6 months post-index', 'timeFrame': '6 months after initiating treatment with secukinumab (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)', 'description': 'Patient reported satisfaction with treatment effectiveness was captured on a 5-point scale - "I believe this treatment is effective in clearing my skin of psoriasis." (1 = strongly agree, 2 = somewhat agree, 3 = Neither agree nor disagree, 4 = Somewhat disagree, 5 = Strongly disagree; n, %) in the EMR data system.\n\nFor this analysis, the responses were classified into three groups:\n\n1. Satisfied with treatment effectiveness (1 = strongly agree, 2 = somewhat agree)\n2. Dissatisfied with treatment effectiveness ( 4 = Somewhat disagree, 5 = Strongly disagree)\n3. Neither satisfied nor dissatisfied with treatment effectiveness (3 = Neither agree nor disagree)'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': 'Baseline (March 1, 2017 - March 1, 2018)', 'description': 'Age information was reported'}, {'measure': 'Gender', 'timeFrame': 'Baseline (March 1, 2017 - March 1, 2018)', 'description': 'Gender information was reported'}, {'measure': 'Number of patients at various regions', 'timeFrame': 'Baseline (March 1, 2017 - March 1, 2018)', 'description': 'Patient regions: Northeast, Midwest, South, West, Unknown'}, {'measure': 'Number of patients with different race', 'timeFrame': 'Baseline (March 1, 2017 - March 1, 2018)', 'description': 'Race: White, Hispanic, African American, Asian, other/unknown'}, {'measure': 'Weight', 'timeFrame': 'Baseline (March 1, 2017 - March 1, 2018)', 'description': 'Weight of patients was reported'}, {'measure': 'Number of patients at Index year', 'timeFrame': 'Study Period: March 1, 2017 - July 31, 2020', 'description': 'Number of patients at each index year were reported'}, {'measure': 'Number of patients with plaque psoriasis subtype', 'timeFrame': 'Baseline (March 1, 2017 - March 1, 2018)', 'description': 'Plaque psoriasis subtype was categorized as: generalized plaque psoriasis, localized plaque psoriasis, localized scalp psoriasis, inverse psoriasis, palmoplantar psoriasis, guttate psoriasis, nail psoriasis, psoriasis vulgaris, ostraceous psoriasis, or plaque psoriasis with unknown subtype during the 12 month pre-index period (including index date)'}, {'measure': 'Number of patients with Plaque location', 'timeFrame': 'Baseline (March 1, 2017 - March 1, 2018)', 'description': 'Plaque location was categorized as recorded in EMR, including hand, arm, leg, trunk, scalp, head and neck, other/unknown'}, {'measure': 'Comorbidities of interest', 'timeFrame': 'Baseline (March 1, 2017 - March 1, 2018)', 'description': 'Comorbidities of interest during the 12 months pre-index were reported'}, {'measure': 'Physician global assessment (PGA)', 'timeFrame': 'Baseline and 6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)', 'description': 'PGA is scored on a 6-point scale from 0-5: 0 = clear, 1 = minimal, 2 = mild, 3 =moderate, 4 = marked, and 5 = severe'}, {'measure': 'Total body surface area (TBSA)', 'timeFrame': 'Baseline and 6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)', 'description': 'Total body surface area (BSA) was expressed as the percentage of body surface involved; BSA values of \\<3%, 3-10%, and \\>10% (reported as n, %) will be considered as mild, moderate, or severe, respectively.'}, {'measure': 'Psoriasis-related therapy', 'timeFrame': '6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)', 'description': 'The following categories were included:\n\n1. Biologics\n2. Methotrexate\n3. Corticosteroids (oral/injection)\n4. Topical therapy\n5. Phototherapy and Psoralen plus ultraviolet A photochemotherapy (PUVA)\n6. NSAID/salicylates\n7. Other systemic plaque psoriasis therapy (Acitretin)\n8. Apremilast (PDE4 inhibitor)'}]}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17921', 'label': 'Results for CAIN457AUS28 from the Novartis Clinical Trials Results Database'}]}, 'descriptionModule': {'briefSummary': "This was a retrospective cohort study utilizing data from Modernizing Medicine Data Services' (MMDS) electronic medical records (EMR)-based dermatology database to evaluate secukinumab patient characteristics, treatment patterns, and outcomes.", 'detailedDescription': "This was a retrospective cohort study utilizing data from Modernizing Medicine Data Services' (MMDS) electronic medical records (EMR)-based dermatology database to evaluate secukinumab patient characteristics, treatment patterns, and outcomes. Psoriasis (PsO) patients initiating secukinumab were identified and indexed to the first secukinumab use using the most recent data at study initiation (data period: March 1, 2018 to August 31, 2019) and with a subsequent data refresh (data period: March 1, 2017 - July 31, 2020)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Psoriasis patients treated with Cosentyx (secukinumab)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥1 orders/administrations for secukinumab within the index window (March 1, 2018 to August 31,2019 for the base analysis; March 1, 2018 to January 31, 2020 for the refresh analysis). The date of the first order or administration was be the index date\n* Patients in the MMDS database with a diagnosis of PsO on or prior to the 1st secukinumab order/administration\n* ≥18 years of age as of the index date\n* To ensure capturing continuous patient activities in the EMR dataset, patients must have at least one more visit (any visit regardless of diagnosis) in addition to the index visit within the first 6 months after secukinumab initiation\n* Patients must have at least one visit (any visit regardless of diagnosis) within the 12 months pre-index period\n\nExclusion Criteria:\n\n* Evidence of secukinumab use in the 12-month pre-index period\n* Data quality issues (missing age, gender, prescription order information)'}, 'identificationModule': {'nctId': 'NCT05320159', 'briefTitle': 'Treatment Effectiveness Among Psoriasis Patients Treated With Cosentyx (Secukinumab)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Characteristics, Treatment Patterns, and Treatment Satisfaction Among Psoriasis Patients Treated With Cosentyx (Secukinumab)', 'orgStudyIdInfo': {'id': 'CAIN457AUS28'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Overall cohort: Secukinumab', 'description': 'Included all the patients treated with secukinumab', 'interventionNames': ['Drug: Secukinumab']}, {'label': 'Bio-naive', 'description': 'Included PsO patients initiating treatment with secukinumab. Bio-naïve was defined as no observed treatment (i.e., injection, prescription or patient reported history) with any of the following biologic drugs of interest anytime pre-index: secukinumab, certolizumab, etanercept, adalimumab, infliximab, golimumab, ustekinumab, ixekizumab, brodalumab, abatacept, and guselkumab and risankizumab during all available history', 'interventionNames': ['Drug: Secukinumab']}, {'label': 'Bio-experienced', 'description': 'Included PsO patients initiating treatment with secukinumab. Patients had pre-index use of one or more of the biologic drugs of interest during all available history', 'interventionNames': ['Drug: Secukinumab']}, {'label': 'Systemic-naive', 'description': 'Included PsO patients initiating treatment with secukinumab. Systemic-naïve was defined as no observed treatment (i.e., injection, prescription or patient reported history) with any of the biologic treatments or with any of the following systemic (i.e., oral or injectable - no topical forms) drugs of interest pre-index: methotrexate, corticosteroids, acitretin or apremilast.', 'interventionNames': ['Drug: Secukinumab']}, {'label': 'Systemic-experienced', 'description': 'Included PsO patients initiating treatment with secukinumab. Systemic-experienced patients had pre-index use of one or more of the systemic drugs of interest.', 'interventionNames': ['Drug: Secukinumab']}], 'interventions': [{'name': 'Secukinumab', 'type': 'DRUG', 'otherNames': ['Cosentyx'], 'description': 'Included all the patients treated with secukinumab', 'armGroupLabels': ['Bio-experienced', 'Bio-naive', 'Overall cohort: Secukinumab', 'Systemic-experienced', 'Systemic-naive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936-1080', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}