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Clinical Trial Summary

The main aim is to quantify the changes in alemtuzumab antibody-anti-alemtuzumab over a 24 months period


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06310343
Study type Observational
Source Queen Mary University of London
Contact
Status Active, not recruiting
Phase
Start date April 25, 2022
Completion date November 30, 2025

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