Rituximab in Graves' Disease (RIGD)
Research type
Research Study
Full title
Adjuvant rituximab – a potential treatment for the young patient with Graves’ hyperthyroidism
IRAS ID
185463
Contact name
Tim Cheetham
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eudract number
2016-000209-35
Duration of Study in the UK
4 years, 3 months, 30 days
Research summary
Thyroid hormone, which is produced by the thyroid gland, has numerous actions including the regulation of brain activity, heart rate and gut function. In Graves’ hyperthyroidism the immune system makes antibodies which stimulate the thyroid gland to produce excess thyroid hormone (hyperthyroidism). The antibodies made by the immune system effectively switch the thyroid gland on continuously. Treating Graves’ hyperthyroidism (often referred to as Graves’ disease) is much more difficult in young people because the available drugs are less likely to result in the disease resolving and are more likely to be associated with side-effects. Only 1 in 4 patients (25%) of young people will be cured after a 2 year course of standard therapy (usually with the drug Carbimazole,CBZ). The other treatments used in people with Graves’ hyperthyroidism - surgery and radioiodine - are associated with additional risks in the young and will make the person dependent on life-long thyroid hormone replacement. Over the last 15 years a drug, rituximab (RTX), that temporarily removes the antibody-generating immune cells (B lymphocytes) from the body has been widely used in different blood and immune conditions. RTX could also improve the outcome in young people with Graves’ hyperthyroidism. This exploratory trial will examine whether the effects of RTX increase the likelihood of Graves’ hyperthyroidism resolving in young people when administered in association with an abbreviated course of standard CBZ treatment. Subjects taking part in the study will be treated with CBZ as well but this will be stopped after 12 months. We will then look to see how many patients remain well off all treatment 12 months later. If this figure is 40% or more then this would indicate that the role of RTX needs to be studied in more detail as part of a larger, randomised trial.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0253
Date of REC Opinion
24 Aug 2016
REC opinion
Further Information Favourable Opinion