Rescue of Steroidogenic Capacity in Adrenocortical Failure Study (RADS)

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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 Glucocorticoids will be gradually withdrawn, in a controlled fashion, and adrenal function re-evaluated at 13, 26, 39 and 52 weeks.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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Newcastle University
• Collaborator: Newcastle-upon-Tyne Hospitals NHS Trust
• Treatments: Rituximab

Criteria

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