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Rescue of Steroidogenic Capacity in Adrenocortical Failure Study (RADS) (RADS)

This study has been completed.
Newcastle-upon-Tyne Hospitals NHS Trust
Information provided by (Responsible Party):
SHS Pearce, Newcastle University Identifier:
First received: September 12, 2008
Last updated: February 5, 2013
Last verified: February 2013
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 Glucocorticoids will be gradually withdrawn, in a controlled fashion, and adrenal function re-evaluated at 13, 26, 39 and 52 weeks.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.

Condition Intervention Phase
Autoimmune Adrenocortical Failure Drug: Solu-medrone, Mabthera Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunotherapeutic Rescue of Steroidogenic Function in Autoimmune Adrenocortical Failure: Pilot Study

Further study details as provided by SHS Pearce, Newcastle University:

Primary Outcome Measures:
  • Peak serum cortisol, basal or post ACTH [ Time Frame: 13, 26, 39, 52 weeks from first treatment ]

Secondary Outcome Measures:
  • 21-OHase antibodies [ Time Frame: 13, 26,39, 52 weeks ]

Enrollment: 6
Study Start Date: September 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Receiving active treatment
Drug: Solu-medrone, Mabthera
125mg, 1gram, twice day 1 and day 15


Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00753597

United Kingdom
Clinical Research Facility, Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
Sponsors and Collaborators
Newcastle University
Newcastle-upon-Tyne Hospitals NHS Trust
Principal Investigator: Simon Pearce, MD, FRCP Newcastle University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: SHS Pearce, Professor of Endocrinology, Newcastle University Identifier: NCT00753597     History of Changes
Other Study ID Numbers: NUTH/2006/4071
EU ID: 2007-003062-18
Study First Received: September 12, 2008
Last Updated: February 5, 2013

Keywords provided by SHS Pearce, Newcastle University:
B cell depletion

Additional relevant MeSH terms:
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on July 19, 2017