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Study Title: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis II
Category: Neurology
Currently accepting participants?
Yes - please read the description below and contact the study coordinator if you are interested.
Principal Investigator: Mariko Kita
Study Coordinator: Cora Fix
Phone: 206.223.6835 Ext.66040
Email: cora.fix@vmmc.org
What is the Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis II study?
Upon signing consent to participate in this trial, screening assessments will be completed. These assessments include collection of demographic information, medical history, a physical exam, neurological testing, laboratory assessments, and tuberculosis screening.
After screening procedures have been completed and eligibility is confirmed, participants will be randomized in a 2:2:1 ratio to receive 2 annual cycles of high dose IV alemtuzumab, low dose IV alemtuzumab, or 3 -times weekly subcutaneous injections of Rebif, respectively.
Laboratory assessments will be completed monthly. Neurological Evaluations will be completed every 3 months.
Estimated Study Completion Date: March 2011
Who can participate?
People who have signed an informed consent form and meet the following criteria may be eligible to participate in this trial:
Age 18 to 55 years old
Diagnosis of relapsing remitting MS
Onset of MS symptoms within 10 years
At least 1 relapse while on treatment 6 months or more
What do I have to do as a study participant?
Study Summary:
The purpose of this study is to establish the efficacy and safety of two different doses of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with Rebif® (interferon beta-1a). The study will enroll patients who have received an adequate trial of disease-modifying therapies but continued to relapse while being treated, and who meet a minimum severity of disease as measured by MRI. Patients will have monthly blood tests and comprehensive testing every 3 months.
Detailed Study Description:
Every patient will receive either alemtuzumab or rebif; there is no placebo. Patients who qualify will be randomly assigned to treatment with either low-dose alemtuzumab, high-dose alemtuzumab, or Rebif® at a 2:2:1 ratio (ie, there is a 4-in-5 chance patients will be assigned to receive alemtuzumab treatment and a 1-in-5 change patients will be assigned to receive Rebif® treatment). Alemtuzumab will be administered in two annual cycles, once at the beginning of the study and again 1 year later. Rebif® will be self-injected 3 times per week for as long as the study continues. All patients will be required to return to their study site every 3 months for neurological assessment. In addition, a safety-related blood test will be performed at least monthly. Participation in this study is estimated to last between 2 and 4 years; patients who receive alemtuzumab will be followed for at least 3 years after their last dose of alemtuzumab.
Study Design: Blinded
Phase of Study: Phase III
Study Type: Interventional
Condition or Study Focus: Relapsing Remitting Multiple Sclerosis
Intervention Type: Drug
Intervention Name: Alemtuzumab vs. Rebif
Gender: Male and Female
Age group: Interventional
Sponsor: Genzyme
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