Multiple Sclerosis Clinical Trial
Official title:
A Study of a New Assay to Detect Anti-drug Antibodies to Alemtuzumab and Their Potential Impact in Multiple Sclerosis
The main aim is to quantify the changes in alemtuzumab antibody-anti-alemtuzumab over a 24 months period
Primary To quantify the longitudinal changes in alemtuzumab ADAs over a 24 month period. Secondary 1. Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2. 2. Relative change in lymphocyte counts after the second infusion of alemtuzumab in ADA positive patients to assess the health economic impact of infusion-related reactions. 3. Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity. 4. Relative change in relapses or EDSS score based on alemtuzumab ADA levels. 5. Relative change in T2 lesion number or Gd-enhancing lesions, and serum NfL based on alemtuzumab ADA levels to assess the health economic impact of disease activity. ;
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