ISRCTN20381716已完成2 期
Adjuvant rituximab – a potential treatment for the young patient with Graves’ hyperthyroidism
ewcastle Upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 27 人开始时间: 2016年11月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
研究概览
简要总结
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30670519 protocol (added 12/02/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/34687316/ (added 03/03/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Excess thyroid hormone concentrations at diagnosis: elevated free tri-iodothyronine (FT3) and / or free thyroxine (based on local assay)
- •2. Suppressed (un-recordable) TSH (based on local assay)
- •3. Patients between the ages of 12-20 years inclusive who are less than 6 weeks from the initiation of anti-thyroid drug treatment (carbimazole or propylthiouracil) for the first time
- •4. 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
- •5. All patients must be willing to use effective forms of contraception for 12 months post-treatment with Rituximab
- •6. If females are of childbearing potential, they must have a negative pregnancy test at screening. This will need to be repeated on the day of RTX administration if more than 7 days has elapsed since the screening visit or a negative pregnancy test.
- •7. Able and willing to adhere to a 2 year study period
排除标准
- •1. Previous episodes of autoimmune thyroid disease
- •2. Patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections) or severely immunocompromised patients
- •3. Patients with known allergy or contraindication to carbimazole and propylthiouracil
- •4. 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)
- •5. Chromosomal disorders known to be associated with an increased risk of autoimmune thyroid disease including Downs’ syndrome and Turners’ syndrome
- •6. Pregnancy, planned pregnancy during the study period or current breast-feeding
- •7. Absence of informed consent from parent/legal guardian for participants age < 16 years
- •8. 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)
- •9. Participants with significant chronic cardiac, respiratory or renal disorder or non-autoimmune liver disease. • Participants with known allergy or contraindication to Rituximab or methylprednisolone
- •10. 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
- •11. Participants in families who know they will be moving out of the catchment areas during the 2 years following RTX treatment
- •12. Participants currently involved in any other clinical trial of an IMP or who have taken an IMP within 30 days prior to trial entry
研究者
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