Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT05368818
Status:
COMPLETED
Last Update Posted:
2022-07-01
First Post:
2022-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Analysis of the Improvement and Quality of Life Trends for UK/ROI Patients Treated With Cosentyx (Secukinumab) in a Retrospective Analysis of the BADBIR Data Source
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C555450', 'term': 'secukinumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 767}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-29', 'studyFirstSubmitDate': '2022-05-05', 'studyFirstSubmitQcDate': '2022-05-05', 'lastUpdatePostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients reporting high/very high QoL changes from Baseline (BL) (from 2 or 3 at BL to 0)', 'timeFrame': 'throughout the study, approximately 4 years (1st July 2015 to 31st August 2019 )', 'description': 'Patient reported QoL for five specific DLQI domains from baseline up to 24 months of UK/ROI psoriasis patients enrolled in BADBIR who were initiated on secukinumab treatment were reported.\n\nFollowing 5 domains were included:\n\n* Embarrassment and/or self conciousness\n* Social leisure\n* Work/study\n* Problems relating to partner, friends and relatives\n* Sexual difficulties'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': 'Baseline', 'description': 'Age was reported'}, {'measure': 'Sex', 'timeFrame': 'Baseline', 'description': 'Sex information was reported'}, {'measure': 'Ethinicity', 'timeFrame': 'Baseline', 'description': 'Ethinicity information was reported'}, {'measure': 'Employment status', 'timeFrame': 'Baseline', 'description': 'Employment status was reported'}, {'measure': 'Smoking Characteristics', 'timeFrame': 'Baseline', 'description': 'Smoking characteristics were reported'}, {'measure': 'Weight', 'timeFrame': 'Baseline', 'description': 'Weight information was reported'}, {'measure': 'Height', 'timeFrame': 'Baseline', 'description': 'Height information was reported'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'Baseline', 'description': 'BMI information was reported'}, {'measure': 'Waist circumference', 'timeFrame': 'Baseline', 'description': 'Waist information was reported'}, {'measure': 'Absolute Psoriasis Area Severity Index (aPASI) at BL', 'timeFrame': 'Baseline', 'description': 'aPASI scores were reported'}, {'measure': 'Total Dermatology Life Quality Index (DLQI) at BL', 'timeFrame': 'Baseline', 'description': 'Total DLQI score was reported'}, {'measure': 'DQLI Domain - 2) embarrassment and/or self-consciousness - proportion of those who reported high or very high at baseline', 'timeFrame': 'Baseline', 'description': 'DQLI Domain - 2) embarrassment and/or self-consciousness - proportion of those who reported high or very high at baseline were reported'}, {'measure': 'DQLI Domain - 5) social and leisure activities - proportion of those who reported high or very high at baseline', 'timeFrame': 'Baseline', 'description': 'DQLI Domain - 5) social and leisure activities - proportion of those who reported high or very high at baseline were reported'}, {'measure': 'DQLI Domain - 7) work/study - proportion of those who reported high or very high at baseline', 'timeFrame': 'Baseline', 'description': 'DQLI Domain - 7) work/study - proportion of those who reported high or very high at baseline were reported'}, {'measure': 'DQLI Domain - 8) problems relating to partner, friends, and relatives - proportion of those who reported high or very high at baseline', 'timeFrame': 'Baseline', 'description': 'DQLI Domain - 8) problems relating to partner, friends, and relatives - proportion of those who reported high or very high at baseline were reported'}, {'measure': 'DQLI Domain - 9) sexual difficulties - proportion of those who reported high or very high at baseline', 'timeFrame': 'Baseline', 'description': 'DQLI Domain - 9) sexual difficulties - proportion of those who reported high or very high at baseline were reported'}, {'measure': 'Number of Biologic naïve/experienced patients', 'timeFrame': 'Baseline', 'description': "Patients were listed as being previously experienced to a biologic treatment if a drug name listed in 'Biologics\\_Drugname', was listed as a 'DrugName' in the DrugPastTherapy table. If a patient had no record of a biologic drugname in the DrugPastTherapy table, the patient was recorded as biologic naive."}, {'measure': 'Number of Psoriatic Arthritis (PsA) patients', 'timeFrame': 'Baseline', 'description': "Patients were classified as Psoriatic Arthritis using the 'PsoriaticArthritis' flag in the Baseline\\_Psoriasis tables. (0=No, 1=Yes, Null=not entered)."}, {'measure': 'Time to PsA diagnosis', 'timeFrame': 'Baseline', 'description': "Time to PsA onset was calculated using the 'PsoriaticArthritisOnset' variable from the FupPsoriasis table and 'YearOnset' from the Baseline Psoriasis table. The time to PsA diagnosis was reported as the difference between 'PsoriaticArthritisOnset' minus 'YearOnset'."}, {'measure': 'Number of patients with No PsA and nail involvement', 'timeFrame': 'Baseline', 'description': "Patients were classified as having nail involvement using the 'NailsNumber' variable from the Baseline\\_Psoriasis table"}, {'measure': 'Number of nails involved', 'timeFrame': 'Baseline', 'description': 'Number of nails involved were reported'}, {'measure': 'Number of patients with at least one Comorbidity', 'timeFrame': 'Baseline', 'description': 'Comorbidities were derived from the MedDRA Preferred Term (PT) variable in the BaselineComorbidities table. If a patient recorded at least one comorbidity, listed within the available data, this patient was recorded as "Has a comorbidity".'}, {'measure': 'Number of patients with five most common comorbidities at BL', 'timeFrame': 'Baseline', 'description': 'Comorbidities were derived from the MedDRA Preferred Term (PT) variable in the BaselineComorbidities table. If a patient recorded at least one comorbidity, listed within the available data, this patient was recorded as "Has a comorbidity". The top 5 comorbidities at baseline were determined via highest frequency of occurrence by cohort and were reported for each subgroup'}, {'measure': 'Frequency of on-label 300mg prescription', 'timeFrame': 'Baseline', 'description': "Frequency of on-label 300mg prescription was categorized into the following, N/A (new convention for licensed dose), Once a week (induction), Once monthly \\& Once every four weeks. To determine if the patients were on-label, confirmation was required that the right dosage was being given; patients were included as on-label if they reported a dose value of 300 using the 'Dose' and the unit mg with the 'DoseUnit' variable in the DrugBiologicTherapy table. The frequency of prescription was assessed using the 'Frequency' variable and mapped in accordance with the following categories: N/A (new convention for licensed dose), Once a week (induction), Once monthly, once every four weeks or Not reported."}, {'measure': 'Proportion of PsA subjects with a total DLQI score of >10', 'timeFrame': 'throughout the study, approximately 4 years (1st July 2015 to 31st August 2019)', 'description': 'Proportion of PsA subjects with a total DLQI score of \\>10 at baseline achieving a score of 0 or 1 at 6-month intervals to 24 months (window of +/- 60 days), stratified by none, any, \\<5 nails, ≥5 nails or all nails involved at baseline was reported.'}, {'measure': 'Proportion of PsA patients with an aPASI score of 0, <=1, <=2 or <=3', 'timeFrame': 'throughout the study, approximately 4 years (1st July 2015 to 31st August 2019)', 'description': 'Proportion of PsA patients with an aPASI score of 0, \\<=1, \\<=2 or \\<=3 at each 6-month interval up to 24 months (window of +/-60 days), stratified by none, any, \\<5 nails, ≥5 nails or all nails involved at baseline was reported.'}, {'measure': 'Proportion of Psoriasis patients with an aPASI score of 0, <=1, <=2 or <=3', 'timeFrame': 'throughout the study, approximately 4 years (1st July 2015 to 31st August 2019)', 'description': 'Proportion of Psoriasis patients with an aPASI score of 0, \\<=1, \\<=2 or \\<=3 at each 6-month interval up to 24 months (window of +/-60 days), stratified by patients being biologic naive or biologic experienced was reported.'}]}, 'conditionsModule': {'keywords': ['Cosentyx,', 'Secukinumab,', 'Quality of Life,', 'UK'], 'conditions': ['Plaque Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17932', 'label': 'Results for CAIN457AGB06 from the Novartis Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'This was a retrospective, observational study of psoriasis patients treated with secukinumab, using secondary data from BADBIR. BADBIR is a UK/ROI pharmacovigilance registry that was initiated in 2007 to monitor the long-term safety of biologic drugs used to treat psoriasis. The study used longitudinal data within the registry to track the trends relating to the disease. For the analysis of improvement and patient reported QoL, patients with a minimum of one follow-up visit were included. The index date was defined as the date of initiation of secukinumab treatment, and follow-up visits were at 6-, 12-, 18-, \\& 24-months post-index.', 'detailedDescription': 'The BADBIR data was current up until the 31st August 2019 for this analysis.\n\nStudy period: From 1st July 2015, as secukinumab was included in BADBIR in January 2016 and patients backdated 6 months, to 31st August 2019.\n\nIdentification period: From 1st July 2015 to 31st August 2019 was used to identify applicable patients for analysis.\n\nIndex date: Initiation of secukinumab treatment within the BADBIR database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The BADBIR registry included patients treated for psoriasis using biologics, conventional systemic therapies, or small molecule immunomodulators', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria for the biologic cohort:\n\n* Age ≥18 years at initiation of secukinumab.\n* At least one follow-up visit post-registry enrollment.\n* On-label dosing of secukinumab of 300mg.\n\nInclusion criteria for the PsA biologic cohort:\n\n* Age ≥18 years at initiation of secukinumab.\n* At least one follow-up visit post-registry enrollment.\n* On-label dosing of secukinumab of 300mg.\n* Diagnosis of PsA at baseline.\n\nExclusion Criteria:\n\n\\- The patient did not meet the criteria stated above.'}, 'identificationModule': {'nctId': 'NCT05368818', 'briefTitle': 'An Analysis of the Improvement and Quality of Life Trends for UK/ROI Patients Treated With Cosentyx (Secukinumab) in a Retrospective Analysis of the BADBIR Data Source', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Analysis of the Improvement and Quality of Life Trends for UK/ROI Patients Treated With Cosentyx (Secukinumab) in a Retrospective Analysis of the BADBIR Data Source', 'orgStudyIdInfo': {'id': 'CAIN457AGB06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All patients', 'description': 'Included all patients prescribed an on-label secukinumab dose', 'interventionNames': ['Other: Secukinumab']}, {'label': 'Patients with Psoriatic Arthritis (PsA)', 'description': 'Included patients classified as having a concomitant PsA diagnosis, if it was declared in the Baseline table', 'interventionNames': ['Other: Secukinumab']}], 'interventions': [{'name': 'Secukinumab', 'type': 'OTHER', 'otherNames': ['Cosentyx'], 'description': 'Included patients treated with Cosentyx (Secukinumab) in a retrospective analysis of the BADBIR data source', 'armGroupLabels': ['All patients', 'Patients with Psoriatic Arthritis (PsA)']}]}, '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'}}}}