Signatures of Immune Reprogramming in Anti-CD52 Therapy of MS: Markers for Risk Stratification and Treatment Response
Signatures of Immune Reprogramming in Anti-CD52 Therapy of MS: Markers for Risk Stratification and Treatment Response
Alemtuzumab is a highly effective therapy in relapse remitting multiple sclerosis (RRMS). The
 aim of this study is to elucidate the mechanism of action of the neuroprotective potential of
 alemtuzumab in RRMS. Therefore, the investigators will semi-annually analyse blood samples of
 RRMS patients treated with alemtuzumab up to 36 months. Using in vitro/ ex vivo assays the
 investigators aim to detect and characterize immune cells including their functional
 activity. Furthermore, the study aims to combine this analysis with clinical data (MRI, EDSS:
 Expanded Disability Status Scale, MSFC: Multiple Sclerosis Functional Composite) to reveal
 the underlining mechanism of action of alemtuzumab to further improve its efficacy and safety
 for present and future patients.
Inclusion Criteria:

 -  Diagnosis of MS according to the McDonald criteria 2010 and cranial MRI scan
 demonstrating white matter lesions attributable to MS within 5 years before prior to
 signing the informed consent form (ICF)

 -  Age > 18 years

 -  Written informed consent to study participation

 Exclusion Criteria:

 -  Medical, psychiatric, cognitive, or other conditions that, in the Investigator's
 opinion, compromise the patient's ability to understand the patient information, to
 give informed consent, or to complete the study

 -  Any progressive form of MS

 -  Any condition that serves as a contraindication for alemtuzumab treatment

 -  Any disability acquired from trauma or another illness that could interfere with the
 evaluation of disability due to MS

 -  Major systemic disease or other illness that would, in the opinion of the
 Investigator, compromise patient safety or interfere with the interpretation of study
 results, e.g., current peptic ulcer disease or other conditions that may predispose to
 hemorrhage

 -  Significant autoimmune disease including but not limited to immune cytopenias,
 rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders,
 vasculitis, inflammatory bowel disease, severe psoriasis

 -  Inability to undergo MRI with gadolinium administration