BAND
Research type
Research Study
Full title
Study of Biological Markers in Autoimmune Neurological Disorders
IRAS ID
221281
Contact name
Sarah J Crisp
Contact email
Sponsor organisation
CUHNFT and the University of Cambridge
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
The aim of this study is to characterise the clinical course and outcome of patients who have, or are suspected to have, autoimmune neurological diseases. The overriding aim is to identify clinical and biological determinants and predictors of disease course in individual patients.
The diseases we are interested in are rare autoimmune or inflammatory conditions affecting the brain, spinal cord or peripheral nerves and include neuromyelitis optica, CNS vasculitis, anti-NMDAR encephalitis among others. At present, these disorders are often the cause of significant morbidity and mortality. Although there is evidence that patients with these disorders respond to treatment with immunosuppressants, there have not been any trials undertaken in these diseases. As a result immunosuppressants are used 'off label', outside their licensed indications and the optimal treatment regimes are unknown. It is often difficult to balance effective treatment with the serious side effects of immunosuppressants. We will collect detailed clinical data from patients under the care of the Cambridge neuroimmunology service to understand the natural history of these diseases and their responses to treatments. This will provide important information to guide the effective treatment of individuals in the future.
Many antibody-associated neurological disorders are difficult to diagnose, and in some cases individuals are suspected of having antibody-associated diseases, but current tests for antibodies are negative. An important aspect of this study is to collect biological samples to use in laboratory studies to identify antibodies and to examine how antibodies cause disease. Understanding disease mechanisms is crucial to develop diagnostic tests and new therapies. Most commonly we will collect blood samples for these studies, but sometimes plasma, CSF or tissue.
The study will be run through the Cambridge neuroimmunology service, which cares for NHS patients throughout East Anglia and accepts referrals from across the UK.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
18/EE/0243
Date of REC Opinion
30 Aug 2018
REC opinion
Unfavourable Opinion