NCT01307332

Advanced MRI Measures of Repair in Alemtuzumab Treated Patients

Advanced Magnetic Resonance Imaging Measures of Repair in Alemtuzumab Treated Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

There are two parts to this investigator sponsored trial (IST): 1. To perform advanced serial MRI studies on patients initiating alemtuzumab therapy. 2. To provide serum samples for the University of Southern California (USC) ICAM125 lymphocyte recovery study.

Detailed description

Multiple Sclerosis (MS) is an inflammatory demyelinating disease of the Central Nervous System (CNS). There are many forms of MS; although the majority are Relapsing Remitting (RRMS) representing approximately 80% of the cases. The disease appears to be more inflammatory in RRMS as manifested by an increase in Gadolinium (Gd) enhancement on MRI and an increase in inflammatory bio-assay markers. Alemtuzumab; a humanized monoclonal antibody that targets the CD52 molecule present on T and B lymphocytes, natural killer (NK) cells, and monocytes and macrophages; effects rapid and sustained lymphocyte depletion and is approved for the treatment of B-cell chronic lymphocytic leukemia in many countries under the names CAMPATH or MabCAMPATH. There are two parts to this Investigator Sponsored Trial (IST): 1. To perform advanced serial MRI studies on patients initiating alemtuzumab therapy. 2. To provide serum samples for the University of Southern California (USC) ICAM125 lymphocyte recovery study.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	MabCampath-1h	Drug:10 mg/mL alemtuzumab intravenous infusion. Form: Sterile, clear, colorless solution. Dosage: 2 cycles. Month 0 dosed over 5 consecutive days; month 12 dosed over 3 consecutive days.

Timeline

• Start date: 2011-03-01
• Primary completion: 2018-09-28
• Completion: 2018-09-28
• First posted: 2011-03-02
• Last updated: 2018-10-16

Locations

1 site across 1 country: Canada