Centocor, Inc., and Schering-Plough Corporation announced today the initiation of the SONIC (Study of Immunomodulator Naive patients in Crohn's Disease) trial that will evaluate the efficacy of
REMICADE® (infliximab) versus azathioprine, a conventional immunosuppressive agent, alone and versus the combination of both drugs for the treatment of patients with Crohn's disease (CD), a serious gastrointestinal disorder. SONIC is the first ever clinical trial to evaluate a biologic therapy compared with a conventional therapy in patients with Crohn's disease. The announcement was made at the 2004 Annual Digestive Disease Week Meeting.
"Although infliximab is a proven, effective treatment for moderately-to-severely active Crohn's disease, many physicians want to know whether they should use REMICADE® before, after or in combination with immunomodulators," said Dr. Thomas F. Schaible, Centocor's vice president of Medical Affairs. "We look forward to receiving the results from the SONIC trial and are confident this trial will provide valuable information on how best to utilize REMICADE® in the management of Crohn's disease."
"We are committed to exploring the full clinical potential of REMICADE® in the treatment of Crohn's disease. The SONIC trial will be very important in helping us understand the further potential benefits of REMICADE® in these patients with active, uncontrolled disease," said Robert Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Corporation.
The SONIC trial will involve immunomodulator-naive, biologic-naive patients with moderately-to-severely active Crohn's disease. The primary endpoint of SONIC is steroid-free remission. Secondary endpoints include mucosal healing and aggregate steroid use.
REMICADE® is a monoclonal antibody that specifically targets and irreversibly binds to tumor necrosis factor-alpha (TNF-a) on the cell membrane and in the blood. Overproduction of TNF-a is believed to play a role in RA and CD and in a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.) in which REMICADE® is currently being studied.
REMICADE® is the only anti-TNF biologic therapy that has received marketing authorizations for the treatment of both Rheumatoid Arthritis (RA) and CD. In the European Union, REMICADE® is also approved for the treatment of Ankylosing Spondylitis. In most countries, REMICADE®, in combination with methotrexate, is indicated for the treatment of patients with moderately-to-severely active RA who have had an inadequate response to methotrexate alone.
REMICADE® is the only biologic indicated for the treatment of patients with moderately-to-severely active CD who have had an inadequate response to conventional therapy. REMICADE® is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD.
About Crohn's Disease
Crohn's disease is a chronic inflammatory bowel disorder that commonly affects the lower part of the small intestine and the large intestine, and typically begins in late childhood or early adulthood. The disease causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss. It is estimated that 500,000 Americans and more than 400,000 people in Europe and Canada suffer from this gastrointestinal disorder.
Many people with heart failure should not take REMICADE®; so, prior to treatment, patients should discuss any heart condition with their doctor. Patients should tell their doctor right away if they develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of the ankles and feet).
There are reports of serious infections, including tuberculosis (TB) and sepsis. Some of these infections have been fatal. Patients should tell their doctor if they have had recent or past exposure to people with TB. Their doctor will evaluate them for TB and perform a skin test.
If a patient has latent (inactive) TB, his or her doctor should begin TB treatment before starting REMICADE®. If a patient is prone to or has a history of infections, currently has one, or develops one while taking REMICADE®, he or she should tell his or her doctor right away. Patients should also tell their doctor if they have lived in a region where histoplasmosis or coccidioidomycosis is common, or if they have or have had a disease that affects the nervous system, or if they experience any numbness, weakness, tingling or visual disturbances.
There are also reports of serious infusion reactions with hives, difficulty breathing and low blood pressure. In clinical studies, some people experienced the following common side effects: respiratory infections (that may include sinus infections and sore throat), coughing and stomach pain or mild reactions to the infusion such as rash or itchy skin. Please read important information about REMICADE®, including full prescribing information at www.remicade.com. For prescribing information for the European Union, call Schering-Plough Corporation at +1 908-298-7616. http://www.jnj.com