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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00753597
Recruitment Status : Completed
First Posted : September 16, 2008
Last Update Posted : February 6, 2013
Newcastle-upon-Tyne Hospitals NHS Trust
Information provided by (Responsible Party):
SHS Pearce, Newcastle University

September 12, 2008
September 16, 2008
February 6, 2013
September 2008
April 2012   (Final data collection date for primary outcome measure)
Peak serum cortisol, basal or post ACTH [ Time Frame: 13, 26, 39, 52 weeks from first treatment ]
Same as current
Complete list of historical versions of study NCT00753597 on Archive Site
21-OHase antibodies [ Time Frame: 13, 26,39, 52 weeks ]
Same as current
Not Provided
Not Provided
Rescue of Steroidogenic Capacity in Adrenocortical Failure Study (RADS)
Immunotherapeutic Rescue of Steroidogenic Function in Autoimmune Adrenocortical Failure: Pilot Study
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 Glucocorticoids will be gradually withdrawn, in a controlled fashion, and adrenal function re-evaluated at 13, 26, 39 and 52 weeks.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.
Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Autoimmune Adrenocortical Failure
Drug: Solu-medrone, Mabthera
125mg, 1gram, twice day 1 and day 15
Experimental: 1
Receiving active treatment
Intervention: Drug: Solu-medrone, Mabthera
Pearce SH, Mitchell AL, Bennett S, King P, Chandran S, Nag S, Chen S, Smith BR, Isaacs JD, Vaidya B. Adrenal steroidogenesis after B lymphocyte depletion therapy in new-onset Addison's disease. J Clin Endocrinol Metab. 2012 Oct;97(10):E1927-32. doi: 10.1210/jc.2012-1680. Epub 2012 Jul 5.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2012
April 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years to 65 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
EU ID: 2007-003062-18
Not Provided
Not Provided
SHS Pearce, Newcastle University
Newcastle University
Newcastle-upon-Tyne Hospitals NHS Trust
Principal Investigator: Simon Pearce, MD, FRCP Newcastle University
Newcastle University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP