Clinical Trial: Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential

Brief Summary:

Alemtuzumab is the active agent of a drug called Lemtrada®. In the European Union, Lemtrada® is approved for the treatment of a particular form of multiple sclerosis (the so called relapsing remitting form). The excellent efficacy of the drug justifies its administration albeit a high risk of considerable side effects. In this context, so called secondary (occurring after the administration of Lemtrada®) autoimmune diseases are of particular importance. In these diseases the immune system acts against structures of the body itself; the reasons are still unknown. Autoimmune diseases may even occur several years after treatment with Lemtrada®. Therefore, patients who once received the drug need to undergo intensive long term health monitoring.

This study aims to elucidate which mechanisms cause to the positive and negative effects of Lemtrada®.

The study includes patients only, who suffer from multiple sclerosis and are indicated to be treated with Lemtrada®. All patients receive the drug according to the official recommendations.

Detailed Summary:
Sponsor: University Hospital Muenster

Current Primary Outcome:

• Absolute change from baseline in naïve CD4 positive T cell counts in peripheral blood [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation. ]
• Relative change from baseline in naïve CD4 positive T cell counts in peripheral blood [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation. ]
• Relative change from baseline in naïve CD8 positive T cell counts in peripheral blood [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation. ]
• Absolute change from baseline in naïve CD8 positive T cell counts in peripheral blood [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation. ]
  12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.
• Absolute change from baseline in CD4 positive T effector cell counts in peripheral blood [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation. ]
• Relative change from baseline in CD4 positive T effector cell counts in peripheral blood [ Time Frame: 12, 24 and 36 months after initiation of investigationa
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • Absolute change from baseline in naïve CD4 positive T cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Relative change from baseline in naïve CD4 positive T cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Absolute change from baseline in naïve CD8 positive T cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Relative change from baseline in naïve CD8 positive T cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Absolute change from baseline in CD4 positive T effector cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Relative change from baseline in CD4 positive T effector cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Absolute change from baseline in CD8 positive T effector cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Relative change from baseline in CD8 positive T effector cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Absolute change from baseline in CD4 positive T memory cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Relative change from baseline in CD4 positive T memory cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Absolute change from baseline in CD8 positive T memory cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Relative change from baseline in CD8 positive T memory cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Absolute change from baseline in CD4 positive regulatory T cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Relative change from baseline in CD4 positive regulatory T cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Absolute change from baseline in CD8 positive regulatory T cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Relative change from baseline in CD8 positive regulatory T cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Absolute change from baseline in Th1 T-helper cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Relative change from baseline in Th1 T-helper cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Absolute change from baseline in Th2 T-helper cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Relative change from baseline in Th2 T-helper cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Absolute change from baseline in Th17 T-helper cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Relative change from baseline in Th17 T-helper cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Absolute change from baseline in recent bone marrow emigrant B cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  • Relative change from baseline in recent bone marrow emigrant B cell counts in cerebrospinal fluid [ Time Frame: 12, 24 and 36 months after initiation of investigational treatment on an optional basis ]
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: University Hospital Muenster
  

  Dates:
  Date Received: March 31, 2015
  Date Started: May 2015
  Date Completion: May 2020
  Last Updated: June 17, 2016
  Last Verified: June 2016