Rescue of Steroidogenic Capacity in Adrenocortical Failure Study (RADS)
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
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 Glucocorticoids will be gradually withdrawn, in a controlled fashion, and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.