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| ID | Type | Description | Link |
|---|---|---|---|
| EU ID: 2007-003062-18 |
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| Name | Class |
|---|---|
| Newcastle-upon-Tyne Hospitals NHS Trust | OTHER |
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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 Glucocorticoids will be gradually withdrawn, in a controlled fashion, and adrenal function re-evaluated at 13, 26, 39 and 52 weeks.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Receiving active treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solu-medrone, Mabthera | Drug | 125mg, 1gram, twice day 1 and day 15 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak serum cortisol, basal or post ACTH | 13, 26, 39, 52 weeks from first treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 21-OHase antibodies | 13, 26,39, 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Pearce, MD, FRCP | Newcastle University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Facility, Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22767640 | Derived | Pearce SH, Mitchell AL, Bennett S, King P, Chandran S, Nag S, Chen S, Smith BR, Isaacs JD, Vaidya B. Adrenal steroidogenesis after B lymphocyte depletion therapy in new-onset Addison's disease. J Clin Endocrinol Metab. 2012 Oct;97(10):E1927-32. doi: 10.1210/jc.2012-1680. Epub 2012 Jul 5. |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |