Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 9:04 AM
Study NCT ID:
NCT05292456
Status:
UNKNOWN
Last Update Posted:
2022-08-03
First Post:
2022-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monıtorıng Glucocortıcoıd Treatment In Patıents Followed In Rheumatology Clınıc
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic 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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2022-03-14', 'studyFirstSubmitQcDate': '2022-03-14', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in Glucocorticoid Toxicity Index (GTI) scores', 'timeFrame': 'Each patient will be followed up for a total of 6 months, at 3 and 6 months.', 'description': 'In this study, it is predicted that a change in GTI scores will be achieved during 3-month follow-up in patients with long-term and newly diagnosed RA, SLE and vasculitis. When the 6-month follow-up of each patient is completed, the study will be terminated.\n\nIn this study, the side effects of glucocorticoids used by patients will be evaluated using the Glucocorticoid Toxicity Index (GTI) index. This index includes areas for commonly recognized adverse events as a result of cumulative steroid exposure. It is weighted and measures both worsening and improvement. Scores range from -346 to 439 with cumulative worsening score relating to an increase in GC toxicity burden. "-" points indicate improvement, "+" points indicate worsening. The higher the patient\'s burden of glucocorticoid toxicity, the higher his score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glucocorticoid toxicity index', 'Drug-Related Problem', 'Glucocorticoid', 'Rheumatoid Arthritis', 'Vasculitis', 'Clinical Pharmacist'], 'conditions': ['Glucocorticoids Toxicity', 'Rheumatoid Arthritis', 'Vasculitis', 'Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'Hypothesis 1: A reduction in side effects is achieved with monitoring glucocorticoid treatment by using the Glucocorticoid Toxicity Index (GTI) in patients using glucocorticoids.\n\nHypothesis 2: Monitoring treatment by using GTI in patients using glucocorticoids causes a decrease in glucocorticoid toxicity and an increase in the quality of life of patients.\n\nHypothesis 3: With the involvement of the clinical pharmacist in the multidisciplinary team in patients using glucocorticoids, the drug-related problems of the patients are detected and prevented.\n\nThe aim of this study was to evaluate the glucocorticoid treatment of patients with RA, SLE and vasculitis treated with glucocorticoids prospectively by a multidisciplinary team with GTI. In addition, it was aimed to identify and prevent drug-related problems by reviewing all drugs used in these patients by the clinical pharmacist.', 'detailedDescription': 'In this study, the side effects of glucocorticoids used by patients will be evaluated using the Glucocorticoid Toxicity Index (GTI) index. This index includes areas for commonly recognized adverse events as a result of cumulative steroid exposure. It is weighted and measures both worsening and improvement. Scores range from -346 to 439 with cumulative worsening score relating to an increase in GC toxicity burden. "-" points indicate improvement, "+" points indicate worsening. The higher the patient\'s burden of glucocorticoid toxicity, the higher his score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of RA, SLE or vasculitis followed in the Hacettepe University Hospitals Rheumatology Outpatient Clinic and receiving glucocortioid therapy will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and over\n* Individuals who have received glucocorticoid treatment for RA, SLE or vasculitis in the last 2 years or at current admission.\n* Patients approved by the physician to participate in the study\n* Patients giving written consent\n\nExclusion Criteria:\n\n* Younger than 18\n* Patients with communication disabilities\n* Patients involved in another clinical and/or drug trial'}, 'identificationModule': {'nctId': 'NCT05292456', 'briefTitle': 'Monıtorıng Glucocortıcoıd Treatment In Patıents Followed In Rheumatology Clınıc', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Monıtorıng Glucocortıcoıd Treatment Using Glucocorticoid Toxicity Index (GTI) In Patıents Followed In Rheumatology Clınıc', 'orgStudyIdInfo': {'id': 'KA- 21026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RA, SLE, and vasculitis patients who have just started glucocorticoid treatment'}, {'label': 'RA, SLE and vasculitis patients receiving glucocorticoid treatment for the last 2 years'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Melda Bahap, master of science', 'role': 'CONTACT', 'email': 'melda_610@hotmail.com', 'phone': '05398979922'}], 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Melda Bahap, master of science', 'role': 'CONTACT', 'email': 'melda_610@hotmail.com', 'phone': '+905398979922'}, {'name': 'Emine Duran, md', 'role': 'CONTACT', 'email': 'docemineduran@gmail.com', 'phone': '+905372103145'}], 'overallOfficials': [{'name': 'Omer Karadag, prof. doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology,'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Melda Bahap', 'investigatorAffiliation': 'Hacettepe University'}}}}