A Phase II Trial of Rituximab in MG is being conducted at multiple locations in the U.S. The study is being led by Dr. Richard J. Nowak at Yale University School of Medicine. It is a multi-center randomized, double-blind, placebo-controlled clinical trial. The study is coordinated by NeuroNEXT, the Network for Excellence in Neuroscience Clinical Trials, with support and funding from the National Institutes of Neurological Disorders and Stroke (NINDS), a division of the National Institutes of Health (NIH).
Northwestern University’s Department of Neurology in Chicago is one of the sites where the study is being conducted. For a list of other sites, visit www.clinicaltrials.org and search on “NCT02110706.”
What is the purpose of this study?
The study purpose is to learn if rituximab is a safe and effective drug for people with myasthenia gravis who are on prednisone. The study will determine if rituximab will help people take less prednisone to manage their myasthenia gravis or possibly be able to discontinue prednisone.
What is a placebo-controlled clinical trial?
A placebo-controlled clinical trial means there will be two groups of people being enrolled in this study. Twenty-five people will receive the study medication (rituximab) and the other 25 people will receive a placebo (an inactive salt-water infusion).
What is Rituximab?
Rituximab is a type of medicine known as a monoclonal antibody (MAB). It works by reducing white blood cells called B cells.
How is Rituximab given?
Rituximab is given through a needle inserted into a vein; this is called an infusion.
What will happen if I choose to be in the study?
- Your first visit will include a review of the informed consent form. If you choose to be in the study, we will do various tests to make sure it is OK to include you in the study.
- You will get rituximab or placebo infusions weekly during the first four weeks of the study and during weeks 24 through 27 of your participation.
- You will come to regular study visits every 4 weeks. At these visits, you will have an MG-focused physical examination and complete questionnaires. Blood samples will also be drawn at each visit.
Who is eligible for the study?
- You must be 21 to 90 years old
- You must have a diagnosis of generalized MG
- You must already be taking a stable dose of steroids
- The study coordinator will provide you a full list of requirements for participation.
To learn more about the study, visit www.clinicaltrials.gov or www.NeuroNEXT.org.
If you live near Chicago, Illinois and would like more information about participating in this study please contact Bartosz Jacher, Clinical Research Coordinator at Northwestern University Department of Neurology, firstname.lastname@example.org or 1.312.695.8636.
To learn about participating at other sites, contact Hong Vu, Yale clinical research coordinator, at email@example.com or 1.203.737.6385.