Rescue of Steroidogenic Capacity in Adrenocortical Failure Study (RADS)

Newcastle University

Status and phase

Completed

Phase 4

Conditions

Autoimmune Adrenocortical Failure

Treatments

Drug: Solu-medrone, Mabthera

Study type

Interventional

Funder types

Other

Identifiers

NCT00753597

EU ID: 2007-003062-18

NUTH/2006/4071

Details and patient eligibility

About

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 Glucocorticoids will be gradually withdrawn, in a controlled fashion, and adrenal function re-evaluated at 13, 26, 39 and 52 weeks.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.

Enrollment

6 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

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