Immunotherapeutic Rescue of steroidogenic function in autoimmune Addison’s Disease (RAD): Pilot study - Rescue of Addison's Disease (RAD)

Phase 1

• Conditions: Autoimmune Addison's disease (adrenocortical failure); MedDRA version: 9.1Level: HLTClassification code 10001343Term: Adrenal cortical hypofunctions

• Registration Number: EUCTR2007-003062-18-GB
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-15
• Study Completion: 2011-05-05
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

-Age 16 to 65 years
-Clear evidence of adrenocortical failure (AAD) with subnormal cortisol response to IV synacthen plus either clinical or biochemical evidence to confirm elevated ACTH, or evidence of mineralcorticoid insufficiency
- Patients are less than 4 weeks from first diagnosis of presumed AAD
- Basal or ACTH stimulated cortisol >150nmol/l
- Normal or atrophic adrenal glands on CT scan
- Willingness to travel to the Wilson Horne Immunotherapy Centre, Newcastle or Harbourne Ward, Royal Devon and Exeter Hospital, for study
- Willingness to attend education sessions about indications for parenteral glucocorticoid administration and technique of administration.
-Female participants of child-bearing age willing to take acceptable contraception during study and for 12 months following last rituximab dose

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Active viral illness, including HIV, Hepatitis B or C, shingles/Zoster
- Recent or partially treated TB; unexplained radiographic abnormality on chest X-ray
- Previous use of immunosuppressive or cytotoxic drugs (excluding glucocorticoid)
- Diabetes mellitus
- Significant cardio-respiratory, chronic renal or non-autoimmune liver disease; malignancy
- Pregnancy, breast feeding or plan for pregnancy within 24 months
- Known non-autoimmune cause for adrenal failure
- Other contraindications to rituximab therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified