Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-04 @ 9:54 PM
Study NCT ID:
NCT05650060
Status:
COMPLETED
Last Update Posted:
2023-04-06
First Post:
2022-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis
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': 163}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-05', 'studyFirstSubmitDate': '2022-12-06', 'studyFirstSubmitQcDate': '2022-12-06', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age', 'timeFrame': 'Baseline', 'description': 'Age information was reported.'}, {'measure': 'Gender', 'timeFrame': 'Baseline', 'description': 'Gender information was reported.'}, {'measure': 'Number of patients with Reimbursement scheme', 'timeFrame': 'Baseline', 'description': 'Reimbursement scheme information was reported.'}, {'measure': 'Weight', 'timeFrame': 'During 3 months pre-baseline', 'description': 'Weight information was reported.'}, {'measure': 'Height', 'timeFrame': 'During 3 months pre-baseline', 'description': 'Height information was reported.'}, {'measure': 'BMI', 'timeFrame': 'During 3 months pre-baseline', 'description': 'BMI information was reported.'}, {'measure': 'Co-morbidities', 'timeFrame': 'During 12 months pre-baseline', 'description': "* Crohn's Disease\n* Diabetes Mellitus\n* Dyslipidemia\n* Hypertension\n* Inflammatory Bowel Disease\n* Latent Tuberculosis\n* Psoriatic Arthritis (PsA)"}, {'measure': 'Psoriasis Area and Sensitivity Index (PASI) score', 'timeFrame': 'During 4 weeks pre-baseline', 'description': 'Psoriasis Area and Severity Index (PASI) is the most widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).'}, {'measure': 'Percentage of Body Surface Area (BSA) involvement', 'timeFrame': 'During 4 weeks pre-baseline', 'description': 'Percentage of Body Surface Area (BSA) involvement was reported.'}, {'measure': 'Disease Life Quality Index (DLQI) score', 'timeFrame': 'During 4 weeks pre-baseline', 'description': "The Dermatology Life Quality Index (DLQI) is a simple, self-administered and user-friendly validated questionnaire. The DLQI is designed to measure the health-related quality of life of adult patients suffering from a skin disease. The DLQI is a validated, 10-question, self-reported questionnaire to evaluate the patient's perception of the impact of psoriasis on quality of life. The DLQI was rated on a 4-point scale (0 = not at all to 3 = very much). The highest possible total score for the DLQI is 30 and higher scores indicate more severe impact on quality of life."}, {'measure': 'Date of first symptom of psoriasis (PSO) / year', 'timeFrame': 'Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)', 'description': 'To describe the PSO treatment history'}, {'measure': 'Date of psoriasis diagnosis / year', 'timeFrame': 'Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)', 'description': 'To describe the PSO treatment history'}, {'measure': 'Duration of psoriasis diagnosis', 'timeFrame': 'Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)', 'description': 'To describe the PSO treatment history'}, {'measure': 'Date of first systemic treatment/ year', 'timeFrame': 'Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)', 'description': 'To describe the PSO treatment history'}, {'measure': 'Date of first biologic agent/year', 'timeFrame': 'Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)', 'description': 'To describe the PSO treatment history'}, {'measure': 'Duration of topical therapy', 'timeFrame': 'Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)', 'description': 'To describe the PSO treatment history'}, {'measure': 'History of topical therapy', 'timeFrame': 'Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)', 'description': 'To describe the PSO treatment history'}, {'measure': 'Duration of systemic therapy', 'timeFrame': 'Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)', 'description': 'To describe the PSO treatment history'}, {'measure': 'History of systemic therapy', 'timeFrame': 'Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)', 'description': 'To describe the PSO treatment history'}, {'measure': 'Duration of biologic therapy', 'timeFrame': 'Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)', 'description': 'To describe the PSO treatment history'}, {'measure': 'History of biologic therapy', 'timeFrame': 'Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)', 'description': 'To describe the PSO treatment history'}, {'measure': 'Date of PsA diagnosis/year', 'timeFrame': 'Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)', 'description': 'To describe the PSO treatment history'}, {'measure': 'Duration of PsA diagnosis', 'timeFrame': 'Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)', 'description': 'To describe the PSO treatment history'}, {'measure': 'Number of patients with baseline PSO treatment', 'timeFrame': 'During 12 months pre-baseline', 'description': 'Topical Therapies\n\n* Topical corticosteroid\n* Coal tar\n* Salicylic acid\n* Vitamin D analogues\n* Anthralin\n* Calcineurin inhibitors\n* Others Oral systemic therapies\n* Methotrexate\n* Acitretin\n* Retinoid\n* Cyclosporine\n* Azathioprine\n* Hydroxyurea\n* Leflunomide\n* Sulfasalazine\n* Others Biologic therapy\n* Infliximab\n* Etanercept\n* Ustekinumab\n* Brodalumab\n* Guselkumab\n* Ixekizumab\n* Others'}, {'measure': 'Duration since the discontinuation of the latest biological agents', 'timeFrame': 'Baseline', 'description': 'Secukinumab therapy'}, {'measure': 'Medication use concomitant to index secukinumab prescription', 'timeFrame': 'Baseline', 'description': 'Secukinumab therapy'}, {'measure': 'Treatment pattern with secukinumab', 'timeFrame': 'Baseline', 'description': 'Secukinumab therapy'}, {'measure': 'Treatment duration since the first dosing till the most recent dosing', 'timeFrame': 'Baseline', 'description': 'Secukinumab therapy'}]}, 'conditionsModule': {'keywords': ['secukinumab,', 'psoriasis,', 'effectiveness,', 'real-world,', 'Thailand'], 'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'This study was a non-interventional, retrospective study collecting data from hospital medical records. Approximately 200 adult patients with moderate to severe plaque psoriasis who were treated with secukinumab from hospitals in Thailand that participated in this study were expected for data collection.', 'detailedDescription': 'The study was performed in 7 study sites in Thailand and planned to involve approximately 200 medical records.\n\nAt each study site, patients who were treated with secukinumab or had ever been treated with secukinumab for moderate to severe plaque psoriasis were included for screening by chronological order starting from the most recent date (April 2021) to September 2017. This was to include the most recent clinical practice in the study.\n\nThe data of patients diagnosed with moderate-to-severe chronic plaque-type psoriasis who received secukinumab in real clinical practice at least 1 dose were collected. The medical records were reviewed to collect the data from the date of the first diagnosis of psoriasis till the most recent dose of secukinumab.\n\nThe data of secukinumab use and clinical outcome (PASI score) were collected at 4 and 16 weeks after first dose initiation and at the most recent dose of secukinumab. The total number of secukinumab injections at the 3-time points were collected.\n\nAn index date was defined for each patient. The first secukinumab injection observed in the medical records was considered the index date for the exploratory endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study was a retrospective medical chart review study. It collected the characteristics of patients who received secukinumab for the treatment of moderate to severe plaque psoriasis as the primary objective.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or female aged ≥ 18 years at index date\n* Previous diagnosis of moderate to severe plaque psoriasis as hospital record with available baseline PASI at index date (date 0 to date -7 prior index date)\n* Initiated treatment with secukinumab for moderate to severe plaque psoriasis during September 2017-April 2021\n\nExclusion Criteria:\n\n\\- Patients diagnosed with other forms of psoriasis other than plaque-type'}, 'identificationModule': {'nctId': 'NCT05650060', 'briefTitle': 'Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'The Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis in Real-world Practice in Thailand', 'orgStudyIdInfo': {'id': 'CAIN457ATH01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Secukinumab', 'description': 'all patients with psoriasis who received secukinumab', 'interventionNames': ['Drug: Secukinumab']}], 'interventions': [{'name': 'Secukinumab', 'type': 'DRUG', 'description': 'all patients with psoriasis who received secukinumab', 'armGroupLabels': ['Secukinumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}