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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
History of Changes
  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 Glucocorticoids will be gradually withdrawn, in a controlled fashion, and adrenal function re-evaluated at 13, 26, 39 and 52 weeks.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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunotherapeutic Rescue of Steroidogenic Function in Autoimmune Adrenocortical Failure: Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Newcastle University:

Primary Outcome Measures:
  • Peak serum cortisol, basal or post ACTH [ Time Frame: 13, 26, 39, 52 weeks from first treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 21-OHase antibodies [ Time Frame: 13, 26,39, 52 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Newcastle University

Additional 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
Study First Received: September 12, 2008
Last Updated: February 5, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Newcastle University:
B cell depletion
steroidogenesis

Additional relevant MeSH terms:
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Rituximab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013