Rescue of Steroidogenic Capacity in Adrenocortical Failure Study (RADS)

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00753597

Acronym

RADS

Enrollment

Registered

2008-09-16

Start date

2008-09-30

Completion date

2012-04-30

Last updated

2013-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Adrenocortical Failure

Keywords

B cell depletion, steroidogenesis

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 Glucocorticoids will be gradually withdrawn, in a controlled fashion, and adrenal function re-evaluated at 13, 26, 39 and 52 weeks.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

Interventions

DRUGSolu-medrone, Mabthera

125mg, 1gram, twice day 1 and day 15

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
21-OHase antibodies	13, 26,39, 52 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026