Graves? orbitopathy MedDRA version: 14.1 Level: SOC Classification code 10014698 Term: Endocrine disorders System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Methylprednisolone
Concentration unit: mg milligram(s)
Concentration number: 500-
Pharmaceutical Form: Tablet
IN
Sponsors
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Huperthyroid patients with Graves disease with a duration =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. CAS ≥4 2. severe ophthalmopathy (optic neuropathy) 3. General contraindications to glucocorticoids 4. Pregnancy 5. Absence of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed