NCT00753597

Rescue of Steroidogenic Capacity in Adrenocortical Failure Study (RADS)

Immunotherapeutic Rescue of Steroidogenic Function in Autoimmune Adrenocortical Failure: Pilot Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Newcastle University · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

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 Glucocorticoids will be gradually withdrawn, in a controlled fashion, and adrenal function re-evaluated at 13, 26, 39 and 52 weeks.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

Conditions

• Autoimmune Adrenocortical Failure

Interventions

Type	Name	Description
DRUG	Solu-medrone, Mabthera	125mg, 1gram, twice day 1 and day 15

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2008-09-16
• Last updated: 2013-02-06

Locations

1 site across 1 country: United Kingdom