Rescue of Steroidogenic Capacity in Adrenocortical Failure Study (RADS)

This study has been completed.
Sponsor:
Collaborator:
Newcastle-upon-Tyne Hospitals NHS Trust
Information provided by (Responsible Party):
SHS Pearce, Newcastle University
ClinicalTrials.gov Identifier:
NCT00753597
First received: September 12, 2008
Last updated: February 5, 2013
Last verified: February 2013

September 12, 2008
February 5, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00753597 on ClinicalTrials.gov Archive Site
21-OHase antibodies [ Time Frame: 13, 26,39, 52 weeks ] [ Designated as safety issue: No ]
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 Glucocorticoids will be gradually withdrawn, in a controlled fashion, and adrenal function re-evaluated at 13, 26, 39 and 52 weeks.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
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
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
Both
16 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00753597
NUTH/2006/4071, EU ID: 2007-003062-18
Yes
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