Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
Multiple sclerosis doesn't hit all women at the same time in life. But it almost always begins before menopause. Symptoms often get worse after childbirth or at the end of a menstrual cycle. When men get MS, it's usually in their 30s or 40s -- just about the time their testosterone levels start to decline. These clues suggest that sex hormones, like estrogen and testosterone, play a role in the disease. It may be the balance of hormones, rather than their actual levels, that's important.
In terms of all types of MS, at least twice as many women as men have the condition. But the ratio may be rising even higher. Some recent estimates place the number at 4 to 1 -- and suggest it is still going up. And ladies are more likely to have their first symptoms at younger ages. Three women for every man got MS before age 20.
If enrolled in the study medication will be divided between treatment groups (cohorts) receiving different doses of ublituximab. There is a 1 in 4 chance that the subject may receive placebo for 28 days prior to receiving ublituximab, but all subjects will eventually receive three doses of ublituximab over the course of 48 weeks. If you are qualified, the Sponsor will issue the cohort assignment to you. You could initially receive placebo, 150 mg, 450 mg or 600 mg of the study drug
Relapsing-remitting multiple sclerosis (RRMS) is the most common form of multiple sclerosis (MS). MS is an autoimmune disease that causes inflammation of the insulating membranes (myelin) that surround nerves within the central nervous system. In RRMS, there are clear episodes of inflammatory activity (relapses).
A Placebo-controlled Multi-Center Phase IIa Dose-Finding Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients with Relapsing Forms of Multiple Sclerosis.
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Do you or a loved one have..
What does it mean?
You or loved one have been previously treated for relapsing forms of Multiple Sclerosis (RMS).
How long is the study?
The study may involve 18 to 24 visits or more to the study site for up to 48 weeks. The time you will
spend in the study will depend on the number of days you are able to complete. Approximately 24 men and women with RMS, ages 18 and over, may participate in this study.
How to participate?
Please take your time to make your decision about taking part. You may discuss your decision with your friends and family. You can also discuss it with your health care team. If you have any questions, you can ask your study doctor for more explanation.
You must be..
18-55 of age
Must have more than 2 relapses in the last 2 years or 1 relapse in the year prior to screening and/or ≥1 Gd enhancing lesion
B cell counts ≥5% of total lymphocytes
Have been diagnosed with relapsing with Multiple Sclerosis
Willingness and ability to comply with trial and strict scheduled follow-up procedures, give written consent
But cannot be..
Treatment with Anti-CD20 or other B cell directed treatment within last 12 months
Treated with Tysabri®(Natalizumab) within the last 12 months prior to screening
Current evidence or known history of clinically significant infection including : a. Chronic or ongoing active infectious disease requiring long term systemic treatment such as, but not limited to: PML, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis (TB), or active hepatitis C b. Previous serious opportunistic or atypical infections c. History of positive serology for hepatitis B or HIV