Newcastle Clinical Trials Unit



Adjuvant Rituximab: a potential treatment for the young patient with Graves’ hyperthyroidism

  • Study stage: Closed
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: Medical Research Council (MRC)
  • Therapeutic area: Metabolic and Endocrine
  • Type of study: CTIMP (rare disease)

Aim: To establish whether a 500mg dose of Rituximab (RTX), when administered together with a 12 month course of ATD, is likely to result in a meaningful improvement in the proportion of young people with Graves' hyperthyroidism entering disease remission.

Primary outcome:

The number of subjects in remission at 2 years following a single dose of RTX and a 12 month course of ATD is the primary trial endpoint: this is equivalent to the number who have not relapsed. Subjects will be deemed to have relapsed if they are receiving any concomitant anti-thyroid drug medication after visit 10 has occurred (due 52 weeks post RTX administration +/- 14 days), or have undergone surgical (thyroidectomy) or RI treatment because of hyperthyroidism at any time following RTX administration. They will also be deemed to have relapsed if serum TSH is less than the lower limit of the normal laboratory reference range and serum FT3 is above the upper limit of the normal laboratory reference range at 2 years (central biochemical analysis in the Newcastle laboratory for TSH and FT3).

  • Population: Paediatric
  • Phase: IIb
  • Design: Cohort
  • Setting: Secondary care
  • Planned Sample Size: 27