Combined Immunotherapy and Trophic Adrenocortical Stimulation in New Onset Autoimmune Addison’s Disease - Rescue of Addison’s disease 2 (RADS2)

ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 17 人开始时间: 2012年6月15日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•- Clear evidence of adrenocortical failure with subnormal cortisol response to 250?g IV synacthen (peak cortisol <300nmol/l) plus either clinical or biochemical evidence to confirm elevated ACTH, or evidence of mineralcorticoid insufficiency
•- Basal or ACTH stimulated serum cortisol >50nmol/l
•- Patients are less than 8 weeks from first diagnosis of AAD
•- Positive serum 21-hydroxylase autoantibodies (>1.0 IU/l on RSR assay)
•- Normal or atrophic adrenal glands on CT scan
•- Willingness to travel to the relevant site for study
•- Willingness to attend education sessions about indications for parenteral glucocorticoid administration and technique of administration.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 4
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 26
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- Active viral illness, including HIV, Hepatitis B or C, shingles/Zoster
•- Recent or partially treated TB or unexplained radiographic abnormality on chest X-ray
•- Previous use of immunosuppressive or cytotoxic drugs (excluding glucocorticoid)
•- Significant cardio-respiratory (inc. asthma), chronic renal or non-autoimmune liver disease
•- Pregnant or breastfeeding and with no plan for pregnancy/ breastfeeding within 24 months
•- Allergy to synacthen, synacthen depot, rituximab or methylprednisolone

发起方

ewcastle upon Tyne Hospitals NHS Foundation Trust