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Study Comparing Thiamazole and Sodium Iodide (131I) for Treating Hyperthyroidism in Patients with Graves' Disease and Active Graves' Orbitopathy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Graves' disease and Graves' orbitopathy, which is a condition affecting the eyes. The study will compare two different approaches to treating these conditions. One approach uses antithyroid drugs, specifically a medication called Tapazole, which is taken in tablet form. The other approach involves an ablative treatment, which means removing or destroying the thyroid tissue, using either radioiodine or a surgical procedure called total thyroidectomy. The purpose of the study is to compare the effects of these two treatment methods on the overall outcome of the eye condition in patients who are also receiving a type of medication called glucocorticoids through an intravenous method.

Participants in the study will be randomly assigned to one of the two treatment groups. Those in the antithyroid drug group will take Tapazole tablets, while those in the ablative treatment group will receive either radioiodine or undergo a total thyroidectomy. The study will last for a period of 24 weeks, during which the effects of the treatments on the eye condition will be monitored and compared. The study aims to determine which treatment approach is more effective in improving the condition of the eyes in patients with Graves' disease and Graves' orbitopathy.

Throughout the study, participants will have regular check-ups to assess their response to the treatment. This will include evaluations by an eye specialist to measure changes in the eyes, such as the size of the eye opening and any swelling or protrusion of the eyes. The goal is to gather information on how each treatment affects the eye condition and to identify the best approach for managing these symptoms in patients with Graves' disease and Graves' orbitopathy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient is required to provide written informed consent. This consent confirms understanding and agreement to comply with the study requirements and restrictions.
Step 2
Initial assessment
An initial assessment is conducted to confirm the diagnosis of Graves' disease and Graves' orbitopathy. This includes checking for hyperthyroidism and the presence of specific antibodies.
The patient's thyroid status is evaluated to ensure it is stable and controlled.
Step 3
Treatment allocation
The patient is randomly assigned to one of two treatment groups: a conservative approach using antithyroid drugs or an ablative approach using radioiodine or total thyroidectomy.
Step 4
Medication administration
For those in the conservative treatment group, the medication Tapazole (5 mg tablets) is administered orally. The dosage and frequency are determined by the healthcare provider based on individual needs.
For those in the ablative treatment group, Sodium iodide (131i) is administered orally in capsule form. The dosage is determined by the healthcare provider.
Step 5
Ongoing monitoring
Throughout the study, regular monitoring is conducted to assess the patient's response to treatment. This includes evaluating eye health, thyroid function, and overall well-being.
The monitoring involves measuring lid aperture, exophthalmos, eye movements, and visual acuity.
Step 6
Completion of study
The study concludes 24 weeks after the patient joins. A final assessment is conducted to evaluate the overall outcome of the treatment on Graves' orbitopathy.
The results are documented and analyzed to determine the effectiveness of the treatment approach.

Who can join the trial?

10 criteria

Patients must be willing and able to provide written consent to participate in the study and follow the study's rules.
Patients must have a diagnosis of **Graves' disease**, which is a condition where the thyroid gland is overactive. This should be confirmed by the presence of specific antibodies in the blood. Patients should have their thyroid levels under control with medication.
The duration of **Graves' disease** should be less than 18 months.
Patients must have **moderate-to-severe Graves' orbitopathy (GO)**, which affects the eyes. This is defined by having at least two of the following in the most affected eye: bulging of the eye by 3 mm or more, double vision, or eyelid retraction by 2 mm or more.
Patients must have **active GO**, which means a Clinical Activity Score (CAS) of 3 or more out of 7 points in the most affected eye. This score helps determine the activity level of the eye condition.
The duration of **GO** should be less than 18 months.
Blood tests for liver enzymes (AST and ALT) and muscle enzyme (CPK) should be no more than 3 times the normal upper limit.
The **absolute neutrophil count**, which is a type of white blood cell count, should be more than 1000 cells per microliter.
Women who can become pregnant and men who are sexually active with such women must use a reliable form of birth control with a failure rate of less than 1% per year for a specified period after the last dose of the study drug.
Participants must be between 18 and 75 years old.

Who cannot join the trial?

10 criteria

Patients who are pregnant or breastfeeding cannot participate.
Individuals with other serious health conditions that might interfere with the study.
Patients who have had previous treatments that could affect the study results.
People who are unable to follow the study procedures or attend follow-up visits.
Individuals who are currently participating in another clinical trial.
Patients with allergies to the study medications or treatments.
Anyone with a history of non-compliance with medical treatments.
Individuals with certain mental health conditions that might affect their ability to participate.
Patients who have had recent surgery or are planning to have surgery during the study period.
People with a history of substance abuse or addiction.

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Universita' Di Pisa
Pisa, Italy

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Investigated drugs

Antithyroid Drugs
are medications used to reduce the production of thyroid hormones in the body. They are part of the conservative approach in this study, aiming to manage hyperthyroidism in patients with Graves' disease. These drugs help control the symptoms by slowing down the overactive thyroid gland.
Radioiodine
is a treatment that involves using radioactive iodine to destroy overactive thyroid cells. This is part of the ablative approach in the study. The goal is to reduce the thyroid's ability to produce hormones, thereby managing hyperthyroidism in patients with Graves' disease.
Total Thyroidectomy
is a surgical procedure that involves the complete removal of the thyroid gland. This is another option in the ablative approach of the study. By removing the thyroid gland, the production of thyroid hormones is stopped, which helps in controlling hyperthyroidism.
Intravenous Glucocorticoids
are a type of steroid medication given through a vein. They are used in this study to treat Graves' Orbitopathy, a condition associated with Graves' disease that affects the eyes. These medications help reduce inflammation and swelling in the eye area.

What is already known about the treatment

Antithyroid Drugs
These medications are typically administered orally and are used to manage hyperthyroidism, particularly in conditions like Graves' disease. They are well-established in medical practice and literature as a conservative treatment option. The main therapeutic indication is to reduce the production of thyroid hormones in patients with hyperthyroidism. At the molecular level, antithyroid drugs work by inhibiting the enzyme thyroid peroxidase, which is crucial for the synthesis of thyroid hormones. They are classified pharmacologically as antithyroid agents.
Radioiodine
This treatment is administered orally in a capsule or liquid form and is used to treat hyperthyroidism by ablating thyroid tissue. It is a well-recognized treatment in medical literature and is often used when medication is not effective. The main therapeutic indication is to reduce thyroid hormone levels by destroying overactive thyroid cells. At the molecular level, radioiodine is absorbed by the thyroid gland and emits radiation that selectively damages thyroid cells. It is classified as a radiopharmaceutical.
Total Thyroidectomy
This is a surgical procedure performed under general anesthesia to remove the thyroid gland. It is a definitive treatment for hyperthyroidism and is well-documented in medical literature. The main therapeutic indication is to eliminate the source of excessive thyroid hormone production. Mechanistically, it involves the physical removal of thyroid tissue, thereby preventing hormone production. It is classified as a surgical intervention.

Investigated diseases

Graves' Disease
Graves' disease is an autoimmune disorder that leads to the overproduction of thyroid hormones, a condition known as hyperthyroidism. It is characterized by symptoms such as rapid heartbeat, weight loss, and nervousness. The disease can also cause swelling of the neck due to an enlarged thyroid gland, known as a goiter. Over time, the excessive thyroid hormone levels can affect various body systems, leading to complications if not managed. The condition is more common in women and often occurs in people with a family history of thyroid or autoimmune diseases.
Graves' Orbitopathy
Graves' orbitopathy, also known as thyroid eye disease, is an inflammatory condition affecting the muscles and tissues around the eyes, often associated with Graves' disease. It can cause symptoms such as bulging eyes, double vision, and eye irritation. The condition results from the immune system attacking the tissues around the eyes, leading to inflammation and swelling. As the disease progresses, it can affect eye movement and vision. The severity of symptoms can vary, and in some cases, the condition may stabilize or improve over time.