Immunotherapeutic Rescue of steroidogenic function in autoimmune Addison’s Disease (RAD): Pilot study - Rescue of Addison's Disease (RAD)

ewcastle upon Tyne Hospitals NHS Trust0 个研究点目标入组 10 人开始时间: 2008年2月15日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•-Age 16 to 65 years
•-Clear evidence of adrenocortical failure (AAD) with subnormal cortisol response to IV synacthen plus either clinical or biochemical evidence to confirm elevated ACTH, or evidence of mineralcorticoid insufficiency
•- Patients are less than 4 weeks from first diagnosis of presumed AAD
•- Basal or ACTH stimulated cortisol >150nmol/l
•- Normal or atrophic adrenal glands on CT scan
•- Willingness to travel to the Wilson Horne Immunotherapy Centre, Newcastle or Harbourne Ward, Royal Devon and Exeter Hospital, for study
•- Willingness to attend education sessions about indications for parenteral glucocorticoid administration and technique of administration.
•-Female participants of child-bearing age willing to take acceptable contraception during study and for 12 months following last rituximab dose
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Active viral illness, including HIV, Hepatitis B or C, shingles/Zoster
•- Recent or partially treated TB; unexplained radiographic abnormality on chest X-ray
•- Previous use of immunosuppressive or cytotoxic drugs (excluding glucocorticoid)
•- Diabetes mellitus
•- Significant cardio-respiratory, chronic renal or non-autoimmune liver disease; malignancy
•- Pregnancy, breast feeding or plan for pregnancy within 24 months
•- Known non-autoimmune cause for adrenal failure
•- Other contraindications to rituximab therapy

发起方

ewcastle upon Tyne Hospitals NHS Trust