TRIUMPH
Research type
Research Study
Full title
Trial of Mycophenolate for Persistent symptoms of Hypothyroidism
IRAS ID
1010665
Contact name
Simon Pearce
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN68248063
Research summary
Hashimoto’s Thyroiditis, also called autoimmune hypothyroidism, happens when the immune system attacks the thyroid gland. This damages the cells that make thyroid hormones, causing low hormone levels. It can also make the thyroid swell (called a goitre) and cause inflammation. The usual treatment is to take daily levothyroxine tablets to replace the missing hormones. However, some people with Hashimoto’s still have symptoms like tiredness, muscle pain, and trouble thinking clearly (known as "brain fog") even after treatment. These ongoing problems might be caused by inflammation in the thyroid, not just low hormone levels.
This trial is testing a drug called Mycophenolate Mofetil (MMF) to see if it can reduce inflammation and help with these symptoms. MMF will be compared to a placebo (a dummy pill) to check if it works.
Since Hashimoto’s mostly affects women, the study will include 48 women. They will be randomly chosen by computer to take either MMF or a placebo for 16 weeks. MMF has been used as an immunosuppressive treatment in organ transplantation for more than 25 years with few side effects and an excellent safety record. Although not previously used in patients with Hashimoto's thyroiditis, MMF has been used for a variety of autoimmune and inflammatory disease in a number of recent clinical trials to reduce inflammation. MMF might reduce inflammation and help with the symptoms in patients with Hashimoto's thyroiditis.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
25/EM/0124
Date of REC Opinion
15 Jul 2025
REC opinion
Further Information Favourable Opinion