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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2007-003062-18-GB |
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Date of registration:
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15/02/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Immunotherapeutic Rescue of steroidogenic function in autoimmune Addison’s Disease (RAD): Pilot study - Rescue of Addison's Disease (RAD)
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Scientific title:
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Immunotherapeutic Rescue of steroidogenic function in autoimmune Addison’s Disease (RAD): Pilot study - Rescue of Addison's Disease (RAD) |
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Date of first enrolment:
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05/06/2008 |
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Target sample size:
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10 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003062-18 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Autoimmune Addison's disease (adrenocortical failure)
MedDRA version: 9.1
Level: HLT
Classification code 10001343
Term: Adrenal cortical hypofunctions
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Intervention(s)
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Trade Name: MabThera
Product Name: MabThera
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Solu-medrone
Product Name: Solu-medrone
Pharmaceutical Form: Powder for injection*
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Primary Outcome(s)
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Main Objective: Primary endpoint is recovery of steroidogenic capacity as judged by basal and dynamic endocrine testing
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Primary end point(s): - Restoration of normal glucocorticoid secretion (peak cortisol >550nmol/l after synacthen)
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Secondary Objective: Improvement in basal ACTH or (recumbent) renin and aldosterone levels
Change in 21-hydroxylase antibody titres
Change in peripheral B-cell counts
Serious adverse reactions; bacterial infections requiring antibiotics; other infective episode
Patient-reported non-serious adverse events
Patient-reported quality of life (EUROQOL-EQ5D questionnaire)
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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