Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-29 @ 10:12 AM
Study NCT ID:
NCT05199103
Status:
UNKNOWN
Last Update Posted:
2022-01-20
First Post:
2021-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antithymocyte Globulin as a Second Line Therapy in Graves Orbitopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049970', 'term': 'Graves Ophthalmopathy'}, {'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D005094', 'term': 'Exophthalmos'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000961', 'term': 'Antilymphocyte Serum'}], 'ancestors': [{'id': 'D007106', 'term': 'Immune Sera'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-14', 'studyFirstSubmitDate': '2021-12-27', 'studyFirstSubmitQcDate': '2022-01-14', 'lastUpdatePostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '≥2 point change in Clinical Activity Score from baseline', 'timeFrame': 'Week 6, 12, 24, 48'}, {'measure': 'change in proptosis', 'timeFrame': '48 weeks'}, {'measure': 'a diplopia response', 'timeFrame': '48 weeks'}, {'measure': 'change of distant best-corrected visual acuity', 'timeFrame': 'Week 6, 12, 24, 48'}, {'measure': 'change of mean retinal sensitivity', 'timeFrame': 'Week 6, 12, 24, 48'}], 'secondaryOutcomes': [{'measure': 'changes in CD4/CD8 ratio', 'timeFrame': 'Week 6, 12, 24, 48'}, {'measure': 'changes in TSH-receptor antibodies level', 'timeFrame': 'Week 6, 12, 24, 48'}, {'measure': 'increase in 1 degree amplitude in Pattern visual evoked potential (VEP) by 1 µV', 'timeFrame': 'Week 6, 12, 24, 48'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Graves disease', 'proptosis', 'antithymocyte globulin'], 'conditions': ['Graves Orbitopathy']}, 'referencesModule': {'references': [{'pmid': '35615718', 'type': 'DERIVED', 'citation': 'Sarnat-Kucharczyk M, Swierkot M, Handzlik G, Kulawik G, Jagoda K, Grochola-Malecka I, Fryzewska J, Mrukwa-Kominek E, Chudek J. Antithymocyte Globulin as Second-Line Therapy in Graves Orbitopathy-Preliminary Results From a Prospective Single-Center Study. Front Endocrinol (Lausanne). 2022 May 9;13:871009. doi: 10.3389/fendo.2022.871009. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of the study is to evaluate the safety and efficacy of rabbit antithymocyte globulin in the treatment of Graves orbitopathy (GO) after ineffective treatment with moderate-to-high doses of glucocorticoids.', 'detailedDescription': 'This is a prospective interventional, single-center study examining the safety and efficacy of rabbit antithymocyte globulin (rATG) in adult patients with active moderate-to-severe GO after ineffective treatment with moderate-to-high doses of glucocorticoids. All enrolled participants will receive 0.8 - 1.0 mg/kg of rATG (cumulative dose of 150-200 mg given intravenously in two or three divided doses, 24 hours apart) after premedication with methylprednisolone i.v. (in total dose of 375 mg), 1 mg of antihistaminic agent clemastine and 1000 mg paracetamol i.v.\n\nIn order to assess efficacy and safety of the treatment, patients will be evaluated at baseline and at 6, 12, 24 and 48 weeks. Baseline and subsequent evaluation will involve medical history, physical examination, including detailed eye examination, laboratory assessment (thyroid-stimulating hormone \\[TSH\\], flow cytometry, TSH-receptor antibodies, CBC) and orbital magnetic resonance imaging (MRI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Graves' disease associated with active thyroid eye disease and a clinical activity score of ≥ 3\n* Euthyroid or with mild hypo- or hyperthyroidism defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50% above or below the normal limits\n* previous ineffective treatment (partial response, recurrence or progression of symptoms) with moderate-to-high doses of glucocorticoids (at least 4.5 g of methylprednisolone)\n\nExclusion Criteria:\n\n* hypersensitivity to rabbit proteins or to any product excipients\n* active acute or chronic infections\n* latent tuberculosis\n* leucopenia below 3000/μl\n* lymphopenia below 400/μl\n* thrombocytopenia below 75000/μl\n* coagulation disorders\n* active malignancy and pregnancy"}, 'identificationModule': {'nctId': 'NCT05199103', 'briefTitle': 'Antithymocyte Globulin as a Second Line Therapy in Graves Orbitopathy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Silesia'}, 'officialTitle': 'Single-centre, Safety and Efficacy, Open-label Study Evaluating Antithymocyte Globulin Treatment in Subjects With Graves Orbitopathy', 'orgStudyIdInfo': {'id': 'KNW-1-075/N/8/K'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rabbit antithymocyte globulin (rATG)', 'interventionNames': ['Drug: rabbit anti-thymocyte globulin']}], 'interventions': [{'name': 'rabbit anti-thymocyte globulin', 'type': 'DRUG', 'description': '0.8 - 1.0 mg/kg of rATG (cumulative dose of 150-200 mg given intravenously in two or three divided doses, 24 hours apart) after premedication with methylprednisolone i.v. (in total dose of 375 mg), 1 mg of antihistaminic agent clemastine and 1000 mg paracetamol i.v.', 'armGroupLabels': ['Rabbit antithymocyte globulin (rATG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40-029', 'city': 'Katowice', 'state': 'Silesian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Gabriela Handzlik', 'role': 'CONTACT', 'email': 'ghandzlik@sum.edu.pl', 'phone': '322591202', 'phoneExt': '0048'}], 'facility': 'Department of Internal Medicine and Oncological Chemotherapy, Medical Faculty in Katowice, Medical University of Silesia', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}], 'centralContacts': [{'name': 'Gabriela Handzlik, Ph.D.', 'role': 'CONTACT', 'email': 'ghandzlik@sum.edu.pl', 'phone': '322591202', 'phoneExt': '0048'}], 'overallOfficials': [{'name': 'Jerzy Chudek, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Silesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Silesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gabriela Handzlik', 'investigatorAffiliation': 'Medical University of Silesia'}}}}