Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-27 @ 12:48 AM
Study NCT ID:
NCT01885533
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2013-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Radioiodine Graves' Management: The PRAGMA-Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D007037', 'term': 'Hypothyroidism'}, {'id': 'D049970', 'term': 'Graves Ophthalmopathy'}], 'ancestors': [{'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 803}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2013-02-15', 'studyFirstSubmitQcDate': '2013-06-20', 'lastUpdatePostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dysthyroidism post-RI between different post-RI management strategies employed by clinicians in the UK', 'timeFrame': '12 months post radio-iodine', 'description': 'To compare the incidence of dysthyroidism post-RI between different post-RI management strategies employed by clinicians in the UK:\n\n* anti-thyroid drugs before and /or after RI\n* anti-thyroid drugs with levothyroxine before and / or after RI\n* watchful monitoring post-RI and introduction of levothyroxine when needed.'}], 'secondaryOutcomes': [{'measure': 'Graves orbitopathy', 'timeFrame': '12 months post-radiodiodine'}, {'measure': 'weight gain', 'timeFrame': '12 months'}, {'measure': "progression of Graves' orbitopathy", 'timeFrame': '12 months'}, {'measure': 'patient satisfaction', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Graves' disease", 'radioiodine', 'thyroid', 'hypothyroidism', "Graves' orbitopathy"], 'conditions': ["Graves' Disease"]}, 'descriptionModule': {'briefSummary': "Thyroid dysfunction following radioiodine for Graves' disease is common, potentially detrimental and avoidable. A variety of clinical strategies are employed in the post-radioiodine era util the patient is on a stable thyroid hormone replacement regimen, which include the use of anti-thyroid drugs, antithyroid drugs with thyroxine, early thyroxine replacement and watchful monitoring until the onset of hypothyroidism. Which of these is most effective in avoiding dysthyroidism, is unknown. This study aims to address this lack of evidence. It will focus on Graves' disease as this is the commonest cause of thyrotoxicosis and the commonest indication for RI therapy. It will provide an insight into potential strategies for improving important clinical outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Adult patients with a history of Graves' disease treated with radioiodine", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Out-patients 18 years of age or over, who have given written informed consent to participate in the study\n* Diagnosed with Graves' disease\n* Received radioiodine for treatment of Graves' disease\n* Had a minimum of 12 months follow-up after RI\n* Most recent RI dose 5 years ago or less at the time of enrollment\n\nExclusion Criteria:\n\n* Patients unable to give informed consent\n* Age 17 years or younger\n* Cause of thyrotoxicosis other than Graves' disease\n* Patients who have had more than one dose of radioiodine can only be included in the study once, using data pertaining to their most recent treatment episode.\n* Patients who might not adequately understand verbal explanations or written information given in English, or who have special communication needs"}, 'identificationModule': {'nctId': 'NCT01885533', 'acronym': 'PRAGMA', 'briefTitle': "Post-Radioiodine Graves' Management: The PRAGMA-Study", 'organization': {'class': 'OTHER', 'fullName': 'Newcastle-upon-Tyne Hospitals NHS Trust'}, 'officialTitle': "POST-RADIOIODINE GRAVES' MANAGEMENT", 'orgStudyIdInfo': {'id': '110269'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Post-radioiodine medication', 'description': 'Anti-thyroid drugs'}, {'label': 'Post-radioiodine medications', 'description': 'anti-thyroid drugs and thyroxine'}, {'label': 'Post-radiodione medication', 'description': 'watchful monitoring'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NE3 4HD', 'city': 'Newcastle upon Tyne', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Newcastle upon Tyne Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Newcastle upon Tyne Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Newcastle-upon-Tyne Hospitals NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cardiff and Vale University Health Board', 'class': 'OTHER_GOV'}, {'name': 'Royal Devon and Exeter NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}