Rescue of ADdiSon?s disease 2

Not Applicable

Completed

• Conditions: Autoimmune Addison's disease; Nutritional, Metabolic, Endocrine; Addison's disease

• Registration Number: ISRCTN20220821
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2019 results in https://doi.org/10.1210/clinem/dgz287 (added 30/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-23
• Study Completion: 2016-10-31
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Part A:
1. Clear evidence of adrenocortical failure with subnormal cortisol response to 250 µg IV synacthen (peak cortisol <300nmol/l) plus either clinical or biochemical evidence to confirm elevated ACTH, or evidence of mineralcorticoid insufficiency
2. Basal or ACTH stimulated serum cortisol >50nmol/l
3. Patients are less than 4 weeks from first diagnosis of AAD
4. Positive serum 21-hydroxylase autoantibodies (>1.0 IU/l on RSR assay)
5. Normal or atrophic adrenal glands on CT scan
6. Willingness to travel to the Wilson Horne Immunotherapy Centre, Newcastle for study
7. Willingness to attend education sessions about indications for parenteral glucocorticoid administration and technique of administration
8. Willingness to use secure contraception during and for 12 months post-treatment with rituximab ((women of childbearing potential)

For Part B, only the first 4 criteria are relevant

Exclusion Criteria

1. Active viral illness, including HIV, Hepatitis B or C, shingles/Zoster
2. Recent or partially treated TB or unexplained radiographic abnormality on chest X-ray
3 .Previous use of immunosuppressive or cytotoxic drugs (excluding glucocorticoid)
4. Significant cardio-respiratory (inc. asthma), chronic renal or non-autoimmune liver disease
5. Pregnant or breastfeeding and with plan for pregnancy/ breastfeeding within 24 months
6. Known allergy or contraindication to synacthen, synacthen depot, rituximab or methylprednisolone

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Restoration of normal glucocorticoid secretion (peak cortisol >550nmol/l after repeat synacthen testing at 48 weeks)

Secondary Outcome Measures

Name	Time	Method
<br> 1. Restoration of normal glucocorticoid secretion (peak cortisol >550nmol/l after repeat synacthen testing at 6,12, 24, and 72 weeks)<br> 2. Improvement of basal and peak cortisol response (>100nmol/l over baseline) to synacthen testing<br> 3. Normalisation of ACTH, Dehydroepiandrosterone (DHEAS), 17á OH-progesterone and recumbent renin and aldosterone levels<br>