Will a single dose of Rituximab treatment, when taken with anti thyroid drugs for 1 year, stop the over-activity of the thyroid gland from returning once you stop ATD treatment?
- Conditions
- Graves' hyperthyroidismTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2016-000209-35-GB
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 27
•Excess thyroid hormone concentrations at diagnosis: elevated free tri-iodothyronine (FT3) and / or free thyroxine (based on local assay).
•Suppressed (un-recordable) TSH (based on local assay).
•Patients between the ages of 12-20 years inclusive that are less than 6 weeks from first diagnosis of Graves’ hyperthyroidism
•Elevated thyroid binding inhibitory immunoglobulin or thyroid receptor antibodies (TRAb including TBII) based on local assay. Patients may or may not have a raised TPO antibody titre.
•Willingness to travel to the regional centres in Birmingham, Doncaster, Edinburgh, Leeds, Newcastle-upon-Tyne or Sheffield.
•If females are of childbearing potential, must have a negative serum pregnancy test at screening.
•Willingness to use 2 forms of contraception for 12 months post-treatment with rituximab (all females of childbearing potential).
•Able and willing to adhere to a 2 year study period.
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
•Previous episodes of autoimmune thyroid disease
•Other concurrent immunomodulatory treatment apart from inhaled steroids for asthma (such as beclomethasone) or topical steroids for skin disorders such as eczema.
•Pregnancy, planned pregnancy during the study period or current breast-feeding
•Absence of informed consent from parent/legal guardian for participants age <16 years.
•Participants with previous use of immunosuppressive or cytotoxic drugs (including rituximab and methylprednisolone but excluding inhaled glucocorticoid and oral glucocorticoid for asthma or topical glucocorticoid for eczema).
•Participants with active viral illness including HIV, Hepatitis B or C, shingles/Zoster.
•Participants with significant chronic cardiac, respiratory or renal disorder or non-autoimmune liver disease.
•Participants with known allergy or contraindication to rituximab or methylprednisolone.
•Participants with evidence of Hepatitis B/C infection, assessed by determining hepatitis ‘B’ surface antigen (HBsAg) status, hepatitis ‘B’ Core antibody (HB Core antibody) status and hepatitis ‘C’ virus antibody (HCV antibody) status.
•Participants in families who know they will be moving out of the catchment areas during the 2 years following RTX treatment.
•Participants currently involved in any other clinical trial of an IMP or who have taken an IMP within 30 days prior to trial entry.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method