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REMICADE for Crohn's

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Please read the Medication Guide for REMICADE® and discuss with your doctor.

Other Clinical Studies Pertaining to REMICADE and Crohn's Disease

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Researchers in the field of gastroenterology have conducted various clinical studies to gain knowledge about Crohn’s disease and the efficacy of REMICADE. Select one of the resources below to learn the results of some of these studies:

Response to Infliximab in Patients with Crohn’s Disease
Response to Infliximab in Patients with Fistulizing Crohn’s Disease

Response to Infliximab in Patients with Crohn’s Disease

Summary based on Targan SR, Hanauer SB, van Deventer SJ, et. al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. N Engl J Med. 1997;337[15].

Study background
In this study, 108 people who had moderately to severely active Crohn's disease and who had failed other treatments were randomly divided into two groups. One group received REMICADE, and one group received placebo (an inactive substance). Neither the patients nor their gastroenterologists knew who was receiving REMICADE and who was receiving placebo until the end of the study. During the study, patients were allowed to continue taking stabilizing doses and their regular medications during the study, such as corticosteroids, 6-MP, and/or antibiotics.

Study findings
Patients were evaluated four weeks after receiving a single dose of REMICADE to determine whether they had achieved a significant improvement in signs and symptoms of Crohn's disease.

After four weeks, 82% of people who received the recommended dose of REMICADE had improvement in the signs and symptoms of their Crohn's disease, compared with only 16% of the people who received placebo.
After four weeks, 48% of people who received the recommended dose of REMICADE (more than half of those who showed improvement) experienced complete remission of their Crohn's disease.

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Response to Infliximab in Patients with Fistulizing Crohn’s Disease

Summary based on Present DH, Rutgeerts P, Targan S, Hanauer SB, et al. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999;340:1398-1405.

Study background
In this study, 94 Crohn's patients who had draining fistulas for at least three months were randomly divided into two groups. One group received REMICADE, and one group received placebo (an inactive substance). Neither the patients nor their gastroenterologists knew who was receiving REMICADE and who was receiving placebo until the end of the study. During the study, patients were allowed to continue taking stabilizing doses and their regular medications during the study, such as corticosteroids, 6-MP, and/or antibiotics.

Study findings
Patients were evaluated to determine whether 50% or more of their draining fistulas closed (stopped draining) for at least one month.

68% of patients receiving the recommended dose of REMICADE had at least 50% of their fistulas close for at least one month, compared with 26% of people who received placebo.
55% of patients receiving the recommended dose of REMICADE had all their fistulas close for at least one month, compared with 13% of people who received placebo.

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IMPORTANT SAFETY INFORMATION

Only your doctor can recommend a course of treatment after checking your health condition. REMICADE^® (infliximab) can cause serious side effects such as lowering your ability to fight infections. There are reports of serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE^®.
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. A rare form of fatal lymphoma has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking REMICADE^® and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including REMICADE^®, the chances of getting lymphoma or other cancers may increase. You should discuss any concerns about your health and medical care with your doctor.

What should I tell my doctor before I take REMICADE^®?

You should let your doctor know if you have or ever had any of the following:

Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start REMICADE^®.
Lived in a region where certain fungal infections such as histoplasmosis or coccidioidomycosis are common.
Infections that keep coming back, have diabetes or an immune system problem.
Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
Heart failure or any heart condition. Many people with heart failure should not take REMICADE^®.
Hepatitis B virus (HBV) infection or think you may be a carrier of HBV.
Nervous system disorders (such as multiple sclerosis or Guillain-Barré syndrome).

Also tell your doctor about any medications you are taking, including vaccines or Kineret (anakinra), and if you are pregnant, plan to become pregnant or are nursing. Adults and children should not receive a live vaccine while REMICADE^®.

What should I watch for and talk to my doctor about before or while taking REMICADE^®?

The following serious (sometimes fatal) side effects have been reported in people taking REMICADE^®.

You should tell your doctor right away if you have any of the signs listed below:

Infections (such as TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. REMICADE^® can make you more likely to get an infection or make any infection that you have worse.
Lymphoma, or any other cancers in adults and children.
Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
Liver injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
Blood disorders—fever that doesn't go away, bruising, bleeding or severe paleness.
Nervous system disorders—numbness, weakness, tingling, changes in your vision or seizures.
Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun. The more common side effects with REMICADE^® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.
Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.

Medication Guide for REMICADE^®

Please read the Medication Guide for REMICADE^® and discuss it with your doctor.
(Requires Adobe^® Reader^®. Click here to download.)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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Last Updated: April 13, 2010