Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:24 PM
Study NCT ID:
NCT07436494
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronavirus Anxiety in Patients Using Biologic vs Conventional DMARDs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-21', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-21', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coronavirus Anxiety Scale Score', 'timeFrame': 'Baseline', 'description': 'Anxiety level measured using the validated Coronavirus Anxiety Scale (CAS). The total score ranges from 0 to 20, with higher scores indicating greater coronavirus-related anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Biologic DMARD', 'Conventional DMARD', 'Coronavirus Anxiety Scale', 'Rheumatology', 'Pandemic'], 'conditions': ['COVID-19', 'Anxiety', 'Rheumatic Diseases']}, 'descriptionModule': {'briefSummary': 'The COVID-19 pandemic has caused significant psychological distress among patients with chronic diseases. Individuals receiving immunosuppressive therapies may experience increased anxiety due to perceived vulnerability to infection. This observational study aims to compare coronavirus-related anxiety levels in patients using biologic disease-modifying antirheumatic drugs (bDMARDs) and those using conventional disease-modifying antirheumatic drugs (cDMARDs).\n\nAdult patients followed at the rheumatology outpatient clinic were contacted by telephone. After verbal consent was obtained, participants completed a patient information form and the Coronavirus Anxiety Scale. Anxiety levels and pandemic-related experiences were compared between treatment groups.', 'detailedDescription': "This observational cohort study was conducted at the Rheumatology outpatient clinic of Uludag University Faculty of Medicine. The study included adult patients diagnosed with rheumatic diseases who were receiving either biologic DMARDs (bDMARDs) or conventional DMARDs (cDMARDs).\n\nDuring the COVID-19 pandemic period, patients were contacted by telephone and informed about the study. Verbal consent was obtained prior to data collection. Demographic and clinical characteristics were recorded using a structured patient information form.\n\nCoronavirus-related anxiety was assessed using the validated Coronavirus Anxiety Scale. The primary objective was to compare anxiety scores between patients receiving biologic and conventional DMARD therapy. Secondary analyses explored patients' perceptions of infection risk and their experiences during the pandemic period.\n\nNo intervention, treatment modification, or additional clinical procedure was performed. The study design is observational, and all data were collected at a single time point."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with established rheumatic diseases under treatment with biologic or conventional DMARD therapy who were actively followed at a tertiary care rheumatology outpatient clinic during the COVID-19 pandemic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of rheumatic disease\n* Currently receiving biologic or conventional disease-modifying antirheumatic drugs (DMARDs)\n* Followed at the rheumatology outpatient clinic during the COVID-19 pandemic period\n* Provided verbal informed consent\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Inability to complete telephone interview\n* Cognitive impairment preventing reliable questionnaire response\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT07436494', 'briefTitle': 'Coronavirus Anxiety in Patients Using Biologic vs Conventional DMARDs', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa City Hospital'}, 'officialTitle': 'Comparison of Coronavirus-Related Anxiety Levels in Patients Using Biologic and Conventional Disease-Modifying Antirheumatic Drugs', 'orgStudyIdInfo': {'id': '2026-Rheumatology-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Biologic DMARD group (bDMARD)', 'description': 'Adult rheumatology patients receiving biologic disease-modifying antirheumatic drugs', 'interventionNames': ['Other: Current treatment (no intervention assigned)']}, {'label': 'Conventional DMARD group (cDMARD)', 'description': 'Adult rheumatology patients receiving conventional disease-modifying antirheumatic drugs', 'interventionNames': ['Other: Current treatment (no intervention assigned)']}], 'interventions': [{'name': 'Current treatment (no intervention assigned)', 'type': 'OTHER', 'description': 'Participants are grouped based on their current prescribed DMARD regimen; no study intervention is administered.', 'armGroupLabels': ['Biologic DMARD group (bDMARD)', 'Conventional DMARD group (cDMARD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16600', 'city': 'Bursa', 'state': 'Türkiye', 'country': 'Turkey (Türkiye)', 'facility': 'Bursa City Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Taner Dandinoğlu', 'investigatorAffiliation': 'Bursa City Hospital'}}}}