EFFECT OF ORAL OR INTRAVENOUS STEROID PROPHYLAXIS ON THE OCCURRENCE OF GRAVES? ORBITOPATHY IN PATIENTS WITH GRAVES? DISEASE AFTER TREATMENT WITH RADIOACTIVE IODINE - Steroid prophylaxis in Graves' ophthalmopathy
- Conditions
- Graves? orbitopathyMedDRA version: 14.1Level: SOCClassification code 10014698Term: Endocrine disordersSystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2009-010632-18-IT
- Lead Sponsor
- FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Huperthyroid patients with Graves disease with a duration <5 years, without or with inactive ophthalmopathy (CAS<4)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1.CAS ≥4
2.severe ophthalmopathy (optic neuropathy)
3.General contraindications to glucocorticoids
4.Pregnancy
5.Absence of informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: -Prevention of the occurrence of active Graves? orbitopathy following treatment of hyperthyroidism with radioactive iodine: comparison between oral and intravenous steroid therapy.;Secondary Objective: - study of the prevalence of orbitopathy after radioiodine therapy in Graves disease, - analysis of parameters influencing the kynetics of 131I and RAI outcome in Graves? patients;Primary end point(s): -Clinical activity score of Graves? orbitopathy>3
- Secondary Outcome Measures
Name Time Method