RIGD2
Research type
Research Study
Full title
Multi-centre randomised, placebo-controlled, single blind trial to investigate the efficacy of adjuvant Rituximab therapy compared to standard Anti-thyroid drug treatment of Graves’ Disease in young people with newly diagnosed disease.
IRAS ID
1010765
Contact name
Claire Wood
Contact email
Sponsor organisation
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN26277327
Research summary
Graves’ disease (GD) is one of the more common disorders of the thyroid, affecting 700 young people in the UK each year. In GD, the immune system mistakenly causes the thyroid gland to produce too much hormone, leading to 4 main symptoms: weight loss, shakiness, heart racing and feeling hot or sweaty. This leads to a profound impact on physical health, quality of life, attention span and education or work performance. Treating GD is more difficult in young people because standard antithyroid drug therapy (ATD) often causes side-effects and is less likely to result in cure when treatment is stopped. Only 1 in 4 patients are cured after 2 years of ATD. Other options if the GD recurs are thyroid surgery or radioactive iodine therapy. These are associated with additional risks and greater costs in the young, necessitate life-long hormone replacement and reduced quality of life. Rituximab (RTX) medication is used to treat many immune disorders. It works by targeting blood cells that make the antibodies responsible for attacking the thyroid in GD. A recent exploratory study suggested that giving just one dose of RTX in addition to standard ATD is well tolerated and may increase the likelihood of remission but needs to be explored in a bigger trial.
Aim
To determine whether a single dose of RTX, given in addition to 2 years of ATD, increases the remission rate in young people with GD.
Design
We will recruit 124 people (12-24 years old) with GD in 26 UK centres. They will be randomly allocated to receive either the usual 2-year course of ATD tablets, or a single dose of RTX as well as 2 years of ATD. RTX is given by a 3-hour drip and participants won’t know whether they received RTX or a salt water infusion instead. We will compare the numbers in each group with normal thyroid function and who have had no further treatment 12 months after stopping ATD. If RTX works, it could be introduced as part of standard GD treatment. This trial is funded by NIHR EME programme.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
25/LO/0301
Date of REC Opinion
11 Jul 2025
REC opinion
Further Information Favourable Opinion