A Research Study for Participants with Grave’s Disease

Do you suffer from Grave’s Disease?

This clinical research study is evaluating an experimental treatment for Grave’s Disease.

Would you like to take part?

As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your health to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others with Grave’s Disease, and whether it will be made widely available to all Canadians. Study volunteers are an important part of moving medical care forward.

You may qualify to participate in this study if you:

• Are at least 18 years of age when signing the Informed Consent document.
• Have a documented diagnosis of Grave’s disease with TRAb (anti-thyrotropin receptor antibody) levels >=ULN (upper limit of normal) at screening
• Have active hyperthyroidism due to Grave’s disease with TSH (thyroid-stimulating hormone) <0.1 mIU/L at screening
• Have been treated with MMI (methimazole) or CBZ (carbimazole) for at least 3 months before screening

You may not qualify to participate if you:

• Have a history of hyperthyroidism not caused by Grave’s disease (eg, toxic adenoma or toxic multinodular goiter)
• Have a history of RAI (radioactive iodine) therapy or received a total thyroidectomy
• Have taken a T3- or T4-containing medication or supplement (eg, levothyroxine, liothyronine, desiccated thyroid preparations, or thyroid-support supplements) <6 weeks before screening
• Have any complication of hyperthyroidism or underlying medical condition that would put you at undue risk. This includes arrhythmia or tachyarrhythmia related to Grave’s disease, such as atrial fibrillation or atrial flutter not sufficiently controlled with medications.
• Have Graves’ orbitopathy/Thyroid Eye Disease (GO/TED) requiring systemic therapy (eg, corticosteroids), orbital injections, orbital surgery, or orbital radiation, or expected immediate surgical intervention and/or planned corrective surgery/irradiation or medical therapy during the study

There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.