MG: Multicenter Trial of Rituximab Opens

A phase 2 clinical trial of rituximab in myasthenia gravis has now opened at 15 U.S. centers under the auspices of NIH's NeuroNEXT

Rituximab, which is given by intravenous infusion, suppresses part of the immune system.
Article Highlights:
  • People with myasthenia gravis often require treatment with high-dose prednisone — a drug that has many unwanted side effects — for many years.
  • Rituximab is an immunosuppressant drug that may allow people with MG to take less prednisone; a phase 2 trial will help determine whether that goal can be achieved and whether rituximab is safe in this disease.
  • The trial is being sponsored by NeuroNEXT, a neurology research network that is part of the U.S. National Institutes of Health (NIH).
by Margaret Wahl on August 11, 2014 - 8:18am

A phase 2 clinical trial of the drug rituximab (Rituxan) in adults with myasthenia gravis (MG) is now open at 15 U.S. centers with plans for additional sites.

Rituximab suppresses a specific part of the body's immune system and is approved by the U.S. Food and Drug Administration (FDA) to treat rheumatoid arthritis and other disorders.

In MG, an "autoimmune" disease, the body's immune system mistakenly attacks the parts of muscle cells that receive signals from nerve cells, resulting in fluctuating weakness that ranges from mild to severe and can even be life-threatening.

MG is currently treated with medications that prolong chemical signals from the nervous system and with drugs that suppress the immune system, particularly corticosteroid medications, such as prednisone. However, corticosteroids often only partially control the disease and can have serious side effects when used for long periods of time.

The goal of this new study is to see whether rituximab can reduce the amount of the corticosteroid prednisone that MG patients require and whether it can do so safely.

The trial is supported by the NeuroNEXT research network, part of the U.S. National Institutes of Health (NIH).

About the phase 2 rituximab trial

The phase 2 trial will include approximately 50 adults with MG, who will be randomly assigned to receive either two sets of intravenous infusions of rituximab or two sets of placebo infusions. Each participant will receive an initial series of four weekly infusions and then another series of four weekly infusions six months later.

All participants will be evaluated at regular intervals for one year.

Participants must

  • be 21 to 90 years old;
  • have generalized MG
  • have elevated immune system proteins called antibodies that interact with acetylcholine receptors, structures on muscle cells that receive signals from the nervous system;
  • be on prednisone at a dosage of at least 15 milligrams per day or the equivalent on alternate days and have been on a stable dose for at least four weeks prior to screening; and
  • meet other study criteria.

Note: This is not a complete list.

Participants must not

  • have a disorder other than MG that can lead to weakness or fatigue;
  • be pregnant, breast-feeding or vulnerable to becoming pregnant;
  • have had a thymectomy (removal of the thymus, an organ in the chest that helps regulate the immune system) within the previous six months;
  • be taking azathioprine, cyclosporine, cyclophosphamide, mycophenolate mofetil, methotrexate or other drugs besides prednisone that suppress the immune system within the previous eight weeks;
  • be using daily nonsteroidal anti-inflammatory drugs (NSAIDs); or
  • have been on an unstable or stable dose of greater than 240 milligrams per day of pyridostigmine (which prolongs the nerve-to-muscle signal) in the four weeks prior to screening.

Note: This is not a complete list.

To participate

Contact the study site nearest you (see list at Phase 2 Trial of Rituximab in Myasthenia Gravis), or contact research coordinator Hong Vu at Yale University in New Haven, Conn., at hong.vu@yale.edu or (203) 737-6385.

For more information

For details about the study and a complete list of study sites with contact information, see Phase 2 Trial of Rituximab in Myasthenia Gravis, or enter NCT02110706 in the search box at ClinicalTrials.gov You may also visit the NeuroNEXT website at neuronext.org/nn103-rituximab-mg which provides additional details as well. See also A Phase II Trial of Rituximab in Myasthenia Gravis, which provides information from NeuroNEXT. Please note that additional NeuroNEXT study sites are planned and may not yet be reflected in the list.

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