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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00753597
First Posted: September 16, 2008
Last Update Posted: February 6, 2013
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.
Collaborator:
Newcastle-upon-Tyne Hospitals NHS Trust
Information provided by (Responsible Party):
SHS Pearce, Newcastle University
  Purpose
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 Glucocorticoids will be gradually withdrawn, in a controlled fashion, and adrenal function re-evaluated at 13, 26, 39 and 52 weeks.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: None (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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753597


Locations
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
Investigators
Principal Investigator: Simon Pearce, MD, FRCP Newcastle University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: SHS Pearce, Professor of Endocrinology, Newcastle University
ClinicalTrials.gov Identifier: NCT00753597     History of Changes
Other Study ID Numbers: NUTH/2006/4071
EU ID: 2007-003062-18
First Submitted: September 12, 2008
First Posted: September 16, 2008
Last Update Posted: February 6, 2013
Last Verified: February 2013

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

Additional relevant MeSH terms:
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents