Status:
UNKNOWN
Signatures of Immune Reprogramming in Anti-CD52 Therapy of MS: Markers for Risk Stratification and Treatment Response
Lead Sponsor:
University Hospital Muenster
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04082260
Start Date
January 1 2017
End Date
January 1 2022
Last Update
September 20 2019
Active Locations (1)
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1
Department of Neurology
Münster, North Rhine-Westphalia, Germany, 48149