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Clinical Trial 14320

Cullman, AL 35058

Study Summary:

Your MS. Your options. What do you see?
If you are living with relapsing-remitting multiple sclerosis (RRMS), life can be unpredictable.

If you have RRMS, you may want to consider talking to your doctor about the MIRROR study.

About the study
The MIRROR study is evaluating whether an investigational medication called ofatumumab affects the number of newly developing MS-related brain lesions and the relapse rate for patients with RRMS. A range of doses of ofatumumab will be tested to help determine which dose and frequency of dosing works the best.

Some participants will receive a placebo for the first three months of the study instead of the study medication. Placebo looks like ofatumumab but does not contain any active medication. Participants will not know to which study drug they have been assigned.

About the study drug
The investigational treatment in this study is a monoclonal antibody called ofatumumab.

Who can participate?
You may be eligible to participate if you:

  • Are 18–55 years of age
  • Have been diagnosed with RRMS
  • Are able to have an MRI
  • Have experienced one of the following:
    • At least one relapse within the previous year or
    • At least two relapses within the previous 2 years or
    • At least one relapse in the previous 2 years with a brain lesion noted on an MRI in the past year
If you are interested in the MIRROR study, your doctor can review other eligibility criteria with you to determine if you may qualify.

What does the study involve?
Participants will be randomly assigned to one of five study groups. Four of the study groups will be given a dose of ofatumumab (3 mg, 30 mg, or 60 mg every 3 months, or 60 mg every month) and one group will be given placebo. Participants assigned to the placebo group will also receive a 3 mg dose of ofatumumab after three months. Both ofatumumab and placebo will be given as an injection under the skin.

Participants will need to visit the study clinic approximately 13 times during the study. Visits during the six-month study drug dosing period are monthly.

During the study, patients will receive study medication and undergo study-related tests and procedures, including:
  • Neurological exams
  • Blood tests and urine tests
  • MRI scans (to evaluate the number of brain lesions)
Where is the study taking place?
The MIRROR study is taking place at sites in approximately 11 countries.

Visit the study website to view a list of study sites.

Sites may be added during the study, so please check back often if there are currently no sites located near you.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.