NCT04776993

A Conservative vs an Ablative Approach for Treatment of Hyperthyroidism in Patients With Graves' Orbitopathy

A Phase III, Randomized, Controlled, Open Label, no Profit, Single-center Intervention Study to Compare the Effect of a Conservative (Antithyroid Drugs) and an Ablative Approach (Radioiodine or Total Thyroidectomy) for the Treatment of Hyperthyroidism in Patients With Graves' Disease and Moderate-to-severe and Active Graves' Orbitopathy (GO) Treated With Intravenous Glucocorticoids (ABLAGO Study)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: University of Pisa · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Graves' disease (GD) is the most frequent cause of hyperthyroidism in iodine sufficient countries and Graves' orbitopathy (GO) is its most common extrathyroidal manifestation. Restoration and maintenance of euthyroidism are imperative in Graves' disease patients with GO. The main treatment options for Graves' hyperthyroidism are antithyroid drugs, radioactive iodine (RAI), and surgery. Whether one or the other therapy for Graves' hyperthyroidism offers the best protection against GO is not established. The study is aimed at comparing the effects of a conservative approach (antithyroid drugs, ATDs, experimental arm) vs an ablative approach (radioiodine or total thyroidectomy) of thyroid treatment on the overall outcome of GO in patients with GD and moderate-to-severe and active GO treated with intravenous glucocorticoids.

Conditions

• Graves' Orbitopathy

Interventions

Type	Name	Description
DRUG	Methimazole	Methimazole for 72 weeks
PROCEDURE	Radioiodine or thyroidectomy	Treatment with radioiodine or with thyroidectomy

Timeline

• Start date: 2023-03-02
• Primary completion: 2024-09-01
• Completion: 2026-03-01
• First posted: 2021-03-02
• Last updated: 2023-03-17

Locations

1 site across 1 country: Italy