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)
EU CTIS ID: 2024-518452-23-00
What this study is testing
To compare 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 at 24 weeks.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Patients willing and capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form 2. A diagnosis of Graves’ disease based on the presence of hyperthyroidism associated with detectable anti-thyrotropic hormone (TSH) receptor autoantibodies (TRAb). Patients must be euthyroid under control on stable medical regimen and every effort will be made to maintain the euthyroid status for the entire duration of the clinical trial. 3. Duration of Graves’ disease shorter than 18 months 4. A moderate-to-severe GO, defined as the presence of at least two of the following criteria in the most affected eye: an exophthalmos ≥3 mm compared with normal values for sex and race; presence of inconstant to constant diplopia; a lid retraction ≥2 mm; active GO (see below) 5. Active GO: CAS ≥ 3 out of 7 points in the most affected eye. Taking into account severity (moderate-to-severe) and activity (CAS ≥ 3/7) of GO, patients are eligible for methylprednisolone treatment according to clinical practice. 6. Duration of GO shorter than 18 months 7. AST, ALT and CPK levels ≤ 3 times the upper value of normal range 8. Absolute neutrophil count >1000 cells/L 9. Women of childbearing potential (WOCBP, namely not in menopause or in menopause since less than two years; in all other instances women will be considered as non-WOCBP) and men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year (as indicated in Appendix) for at least 6 and 7,5 months, respectively, after the last dose of the investigational drug (see also 2014_09_HMA_CTFG_Contraception.pdf, namely the “2014 CTFG Recommendations related to contraception and pregnancy testing in clinical trials”) 10. Male and female patients of age 18-75 years
You likely can't join if
- 1. Optic neuropathy or sight threatening GO of any type 2. Previous therapy for Graves’ disease with radioiodine or thyroidectomy 3. Corticosteroids or other immunosuppressive treatment for GO or other reasons in the last 3 months. 4. Previous surgical treatment and/or radiotherapy for GO. 5. Contraindications to GC: hypersensitivity to the active substance or to any of the excipients; uncontrolled hypertension, uncontrolled diabetes; history of peptic ulcer; urinary infections, glaucoma, systemic fungal infections, systemic infections unless appropriate therapy is employed, idiopathic thrombocytopenic purpura, cerebral edema associated with malaria. 6. Contraindications to RAI. 7. Previous or current glucocorticoid-related psychosis. 8. Use of medications interfering with GC or increasing the risk of GC-related adverse events (see prohibited therapies) 9. Acute or chronic liver disease 10. Contraindications to MMI: hypersensitivity to the active substance or to any of the excipients; breastfeeding 11. Contraindications of any kind to perform thyroidectomy 12. Relevant Malignancy 13. Recent (≤1 year) history of alcoholism or drug abuse 14. Mental illness that prevent patients from comprehensive, written informed consent 15. Pregnancy or breastfeeding
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.