Rescue of Steroidogenic Capacity in Adrenocortical Failure Study (RADS)

Phase 4

Completed

Brief Summary: This is a pilot study of B lymphocyte depletion therapy in an attempt to salvage adrenal steroidogenic capacity in ten subjects with early autoimmune Addison's disease. During the first twelve weeks of treatment, additional glucocorticoid therapy (prednisolone) will be given to ensure wellbeing and to rest the steroidogenic apparatus that is the target of the autoimmune attack. Glucocorticoids will be gradually withdrawn, in a controlled fashion, and adrenal function re-evaluated at 13, 26, 39 and 52 weeks. The primary endpoint will be restoration of steroidogenic function as judged by conventional endocrine indices of adrenocortical function. B cell depletion may ameliorate the autoimmune attack against adrenal cells, potentially allowing a state of immune tolerance to be restored with subsequent recovery of adrenal steroidogenic capacity.

Recruitment & Eligibility

Inclusion Criteria

Clear evidence of primary adrenal failure (elevated ACTH, pigmentation, electrolyte disturbance)
Basal or stimulated cortisol <400 nmol/l but >100nmol/l

Exclusion Criteria

Active viral infection, pregnancy or breast feeding, previous immunosuppression, diabetes, cardiorespiratory disease, renal failure, hepatic disease, cancer
Calcified or enlarged adrenals on CT scan, active TB

Arm && Interventions

Group	Intervention	Description
1	Solu-medrone, Mabthera	Receiving active treatment

Primary Outcome Measures

Name	Time	Method
Peak serum cortisol, basal or post ACTH	13, 26, 39, 52 weeks from first treatment

Secondary Outcome Measures

Name	Time	Method
21-OHase antibodies	13, 26,39, 52 weeks

Locations (1): Clinical Research Facility, Royal Victoria Infirmary
🇬🇧
Newcastle upon Tyne, United Kingdom

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