FAQs

  • If you take part in this study, you will take either mycophenolate tablets or a placebo “dummy” tablet that doesn’t contain any drugs or medicine.

    Mycophenolate is a medicine that suppresses the immune system. It's been used for over 25 years to prevent organ rejection and treat autoimmune diseases. This trial is exploring whether it can also reduce thyroid inflammation in people with Hashimoto’s thyroiditis.

    If you receive the placebo, you will not get a direct benefit from the treatment.

    You will be asked to take one tablet of the trial medicine twice each day.

    You will also keep taking your usual thyroid medicine during the trial. The trial doctor will check your thyroid hormone levels and adjust your dose if needed.

  • The most common side effects of mycophenolate are mild stomach issues like nausea, indigestion, or loose stools. Rarely, it can affect white blood cells or liver function (in less than 5% of people). To ensure safety, we’ll check your blood and liver every two weeks during the first two months of the trial.

    Mycophenolate is known to be harmful to an unborn baby. If you could become pregnant, you’ll have monthly pregnancy tests and we will talk to you regularly about the possibility of pregnancy during the trial. If you’re planning to become pregnant, you should not take part. Mycophenolate takes about six weeks to leave your system and pregnancy would be safe again six weeks after you stop taking trial medicine.

  • You’ll have up to nine appointments at the Royal Victoria Infirmary (RVI) in Newcastle. If you prefer, two of these appointments may be done at your home, local GP practice or in your community.

    You’ll also have two PET scans at the Freeman Hospital in Newcastle. One near the start of the trial and one near the end.

    At your first trial appointment, a trial team member will discuss the trial with you and answer any questions you may have. If you are happy to continue, you will be asked to sign a consent form.

    During the trial you will:

    • Be asked about any medicines you may take and any illnesses you’ve had.

    • You’ll have a procedure called a fine needle aspiration to take a sample of cells from your Thyroid. Once near the start of the trial and once near the end.

    • Provide blood samples.

    • If you could become pregnant, you’ll also be asked to provide a urine or blood sample for pregnancy testing

    • Fill out questionnaires about your tiredness and any worries that you may have and the impact it has on you day to day.

  • At the end of the trial, you’ll receive a £100 supermarket voucher as a thank you.

    The trial team can arrange taxi travel for your appointments or repay reasonable travel costs.

    We can also cover up to half a day of childcare costs for pre-school children during longer visits and PET scan appointments at the Freeman Hospital.

  • The Study is being managed by the Newcastle Clinical Trials Unit and sponsored by the Newcastle upon Tyne Hospitals NHS Foundation Trust.

  • If you choose to take part in this research study, we will use information from you, your medical records and your GP. We will only use information that we need for the research study. Only a few people who really need it will see your name or contact details. Everyone involved in this study will keep your data safe and secure and follow privacy rules. 

    After the study ends, we will keep some of the data in case we need to check it and for use in future research. We will make sure no-one can work out who you are from the reports we write.

  • Hashimoto’s thyroiditis is significanlty more common in the female population. Approximately 10% of the female population have Hashimoto’s thyroiditis. Unfortunately this trial will specifically be looking at women between the ages of 18 and 50 as the demographic most affected by the condition.

    We hope that the results of this trial will lead to an improved understanding and treatment for thyroid diseass that will benefit men and women of all ages.

  • Hashimoto’s thyroiditis is a common autoimmune disease where the body’s immune system attacks the thyroid gland, a small gland in your neck that controls your metabolism by making thyroid hormones.

    Many people think that Hashimoto’s thyroiditis is a rare form of hypothyroidism however 90% of hypothyroidism is due to Hashimoto’s thyroiditis.