Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT03501420
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2018-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adelphi Primary Sjogren's Syndrome (pSS) Disease Specific Programme (DSP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012859', 'term': "Sjogren's Syndrome"}], 'ancestors': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2223}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-21', 'studyFirstSubmitDate': '2018-04-10', 'studyFirstSubmitQcDate': '2018-04-10', 'lastUpdatePostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physician reported categorization of pSS subjects', 'timeFrame': 'Baseline', 'description': 'The most common categorization of pSS subjects by rheumatologists will be described, alongside differences in humanistic and clinical burden of these categories.'}, {'measure': 'Statistically derived clusters of pSS subjects', 'timeFrame': 'Baseline', 'description': 'Subject clusters will be statistically derived from demographic, clinical and humanistic characteristics.'}], 'secondaryOutcomes': [{'measure': "Description of subject's journey", 'timeFrame': 'As reported', 'description': "Summary of subject's journeys from diagnosis to current management and treatment, including an overview of HCRU."}, {'measure': 'Drivers of physician and subject reported satisfaction', 'timeFrame': 'Baseline', 'description': 'Data for drivers of physician and subjects reported satisfaction with disease activity control and symptomatic relief will be derived.'}, {'measure': 'Level of concordance/discordance between physician and patient reported satisfaction', 'timeFrame': 'Baseline', 'description': 'Data for discordance/concordance between physicians and subjects across key measures will be derived.'}, {'measure': 'Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective', 'timeFrame': 'As reported / Baseline', 'description': 'Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective will be described.'}, {'measure': 'Physician experience of biologic therapy', 'timeFrame': 'Baseline', 'description': "Physicians' experience of biologic therapy, and attitudes towards biologic therapy for subjects with pSS will be described."}, {'measure': 'Physician perception of treatment targets', 'timeFrame': 'Baseline', 'description': "Physicians' perceptions of treatment targets in pSS will be described."}, {'measure': 'subjects attitude towards route of administration', 'timeFrame': 'Baseline', 'description': 'Proportion of subjects willing to take medication by type of administration route (oral/tablet, subcutaneous injection, intravenously) will be described.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Belimumab', 'Disease Specific Programme', 'rheumatologist', 'Benlysta', "Primary Sjögren's Syndrome", 'Adelphi pSS DSP'], 'conditions': ["Sjogren's Syndrome"]}, 'descriptionModule': {'briefSummary': "Sjogren's Syndrome is a chronic autoimmune disease characterized by sicca (dryness) symptoms of the mouth and eyes. This autoimmune disease is less commonly studied and there are no licensed treatments to treat the underlying cause of disease and current management is based on clinical experience and/or small clinical studies. This study is based on DSP methodology, a multinational, cross-sectional, multi-sponsor survey of robust real-world data. DSP methodology collects quantitative market research data. The pSS DSP will survey a sample of approximately 230 to 325 rheumatologists and their prospectively consulting pSS subjects in France, Germany, Italy, Spain and the US. The data will be collected via physician interviews, physician workload questionnaires, detailed patient record forms (PRFs) to be completed by physicians, and a self-completion questionnaire by pSS subjects. The data collected using this method includes subjective and objective evidence, clinical information about individual patients, their disease and their treatment. This DSP will follow three key phases: preparatory phase, data collection phase and data processing/analysis phase."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 230-325 rheumatologists actively involved in management and treatment decisions of pSS subjects in France, Italy, Spain, Germany and the United States and their prospectively consulting subjects with a confirmed diagnosis of pSS will be included in the DSP.', 'eligibilityCriteria': "Inclusion Criteria:\n\nPhysician eligibility criteria:\n\n* Primary physician specialty identified as Rheumatologist\n* Physicians who currently treat 7 or more pSS subjects in a typical month\n* Physicians who are actively involved in the management and treatment decisions of pSS subjects\n\nSubject eligibility criteria:\n\n* Subjects with a diagnosis of Sjogren's syndrome in the opinion of the rheumatologist in the absence of Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA) or Systemic Sclerosis.\n* For main sample (6 subjects per rheumatologist)\n* Subjects with age \\>=18 years and with confirmed diagnosis of pSS and are currently, or have previously, exhibited disease activity in one or more of the categories: fever of non-infectious origin, lymphadenopathy/lymphoma, glandular swelling/enlarged parotid gland, arthralgia/synovitis, erythema/vasculitis/purpura, pulmonary involvement, renal involvement, myositis, peripheral nervous system involvement, central nervous system involvement, cytopenia of autoimmune origin (with neutropenia) and/or anemia and/or thrombocytopenia and/or lymphopenia, hypocomplementemia and/or hypergammaglobulinemia and/or cryoglobulinemia or hypogammaglobulinemia and/or Ever received immunosuppressant or biologic treatment.\n* For oversample (1 subject per rheumatologist)\n* Subjects with age \\>=18 years and with confirmed diagnosis of pSS that fit the following criteria: Has never exhibited disease activity in any of the categories above, Moderate or severe fatigue (in the opinion of the rheumatologist)\n\nExclusion Criteria:\n\n* Not applicable"}, 'identificationModule': {'nctId': 'NCT03501420', 'briefTitle': "Adelphi Primary Sjogren's Syndrome (pSS) Disease Specific Programme (DSP)", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Patient Phenotypes and Treatment Pathways in Primary Sjogren's Syndrome: an International Cross-sectional Survey of Rheumatologists and Adult Primary Sjögren's Syndrome Patients With Systemic Involvement (Adelphi 2018 pSS Disease Specific Programme)", 'orgStudyIdInfo': {'id': '207382'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Physicians', 'description': 'A sample of 230 to 325 rheumatologists actively involved in management and treatment decisions of pSS subjects in France, Italy, Spain, Germany and the United States will be included in the survey.', 'interventionNames': ['Other: Interview', 'Other: PRFs']}, {'label': 'Subjects with pSS', 'description': 'Subjects with a confirmed diagnosis of pSS under consultation of the rheumatologists enrolled in the study will be included.', 'interventionNames': ['Other: PSC questionnaire']}], 'interventions': [{'name': 'Interview', 'type': 'OTHER', 'description': 'A one hour survey interview will be completed by the rheumatologists which will contain open and closed questions to probe physician perception and behaviors in relation to pSS management and treatment', 'armGroupLabels': ['Physicians']}, {'name': 'PSC questionnaire', 'type': 'OTHER', 'description': 'All subjects for whom the physician completes a PRF will be required to complete a PSC questionnaire independently of their physician, immediately after consultation.', 'armGroupLabels': ['Subjects with pSS']}, {'name': 'PRFs', 'type': 'OTHER', 'description': 'PRFs will be completed by the physicians for seven of their consulting pSS subjects.', 'armGroupLabels': ['Physicians']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SK10 5JB', 'city': 'Cheshire', 'country': 'United Kingdom', 'facility': 'Adelphi Real World Investigational Site'}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}, {'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Adelphi Real World', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}