Radioiodine ablation of post-surgical thyroid remnants by recombinant human TSH (rhTSH) in patients with moderately severe and severe Graves' orbithopathy (GO) - Graves' orbithopathy and rhTSH

Conditions: Patients affected with moderately severe and severe GO
MedDRA version: 14.1Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 14.1Level: HLGTClassification code 10043739Term: Thyroid gland disordersSystem Organ Class: 10014698 - Endocrine disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2010-020855-29-IT

Lead Sponsor: IVERSITA' DEGLI STUDI DI MESSINA

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

1. Hyperthyroidism onset<6 months treated only with anti-thyroid drugs; 2. GO onset <6 months; 3. Thyroid surgery indication (thyroid volume >15 ml and/or nodular goiter and/or hyperthyroidism relapse during despite anti-thyroid drugs and/or poor compliance to the medical treatment); 4. Moderately severe and severe GO; 5. Clinically active GO (Clinical Activity Score >3/7
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. Hyperthyroidism onset >6 months or previously treated by radioiodine or thyroidectomy; 2. GO onset >6 months; 3. Mild GO; 4. Previous GO treatment by glucocorticoids, orbital irradiation or decompressive surgery; 5. Urgent orbital decompressive surgery; 6. Histopathological evidence of thyroid malignancy; 7. Pregnancy or breast-feading

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the overall outcome of GO in terms of improvement, worsening or stability, following radioiodine ablation of post-surgical thyroid remnants, in patients with moderately severe and severe GO, at the end of the follow up period (12 months);Secondary Objective: 1. To evaluate the effects of acute rhTSH administration in GO; 2. To evaluate the overall outcome of GO at 45 days, 3 and 6 months following thyroidectomy/total thyroid ablation; 3. To evaluate changes in the quality of life during and at the end of the follow up period (3, 6 and 12 months);Primary end point(s): Improving moderately severe and severe GO outcome

Secondary Outcome Measures