Rescue of Addison’s disease 2 (RADS2)

• Research type

  Research Study

• Full title

  Combined Immunotherapy and Trophic Adrenocortical Stimulation in New Onset Autoimmune Addison’s Disease

• IRAS ID

  107445

• Contact name

  Simon Pearce

• Sponsor organisation

  The Newcastle upon Tyne Hospitals NHS Foundation Trust

• Eudract number

  2012-001682-33

• ISRCTN Number

  N/A

• Research summary

  Addison??s disease is caused by the immune system destroying the function of the adrenal glands, which make essential steroid hormones. In many patients with newly diagnosed Addison??s disease, the adrenal glands are not yet completely destroyed. Except in cases of severely delayed diagnosis, they may still be working at as much as 50% of normal capacity. This is enough adrenal depletion to make people feel consistently unwell. After patients begin treatment with conventional steroid replacement therapy for Addison??s disease, the remaining adrenal function is gradually and imperceptibly destroyed. This study will examine whether a combination of an antibody treatment called rituximab, and a hormone treatment called ACTH (adrenocorticotropin) could lead to partial or full recovery from autoimmune adrenal destruction. The rituximab removes the B cells from the body, which are a key part of the damaging immune response and the ACTH will stimulate the surviving adrenal cells to recover. The combination might allow regeneration of the adrenal glands and a possible cure of Addison??s disease.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  12/NE/0339

• Date of REC Opinion

  28 Sep 2012

• REC opinion

  Favourable Opinion