ACT 1 and ACT 2 Clinical Studies

The approval for REMICADE therapy in ulcerative colitis was based on the results of 2 worldwide clinical studies, ACT 1 and ACT 2. ACT stands for Active Ulcerative Colitis Trial.

What types of ulcerative colitis patients were studied in the ACT 1 and ACT 2 clinical studies?

A total of 728 patients with moderate to severe ulcerative colitis participated in the ACT 1 and ACT 2 studies. In order to participate in these studies, patients were required to have uncontrolled disease despite taking other therapies, such as aminosalicylates, steroids, and/or immunosuppressants (e.g., azathioprine or 6-mercaptopurine).

How was REMICADE studied in ACT 1 and ACT 2?

Participants in the studies continued their previous therapy for ulcerative colitis. They were divided into three groups and received one of the following treatments intravenously (IV):

REMICADE at 5 mg/kg,
REMICADE at 10 mg/kg, or
No REMICADE

In ACT 1, the first dose was given at the start of the study (Week 0), followed by doses 2 and 6 weeks later, and then every 8 weeks thereafter for almost 1 year.

In ACT 2, the first dose was given at the start of the study (Week 0), followed by doses 2 and 6 weeks later, and then every 8 weeks thereafter for almost 6 months.

The goal of the study was to measure the following effects of REMICADE treatment:

Symptom improvement, or “response”
Periods of no symptoms or very few symptoms, or “remission”
Healing of the inflamed, ulcerated intestinal lining, or “mucosal healing”

Results from the ACT 1 study:

Response: Symptom improvement was seen in nearly 7 out of 10 patients after 3 doses of REMICADE compared with 4 out of 10 patients who received placebo.
Remission: Nearly 40% of patients also experienced periods of no symptoms or very few symptoms after 3 doses of REMICADE versus 15% in patients who received placebo.
Healing: Over half of the patients experienced healing of their damaged intestinal lining after 3 doses of REMICADE compared to one-third of patients who received placebo.
Reduction or Elimination of steroid use: Nearly 1 out of 4 patients who were on steroids at the start of the study were able achieve periods of no symptoms or very few symptoms with REMICADE and stop using steroids within 8 months compared to 1 out of 10 patients who received placebo.

All of these results were statistically significant.

Results from the ACT 2 study:

The results in ACT 2 were consistent with those described in ACT 1. More patients who received REMICADE versus placebo experienced symptom improvement, symptom remission, healing of the intestinal lining, and elimination of steroid use.

All of these results were statistically significant.

IMPORTANT SAFETY INFORMATION

How will my doctor decide if REMICADE^® is right for me?

Only your doctor can recommend a course of treatment after checking your health condition. Your doctor should discuss with you any potential benefits and risks and help you make the best treatment decision. While REMICADE^® may help you feel better, like other medicines that affect your immune system, it 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.^® 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 like histoplasmosis or coccidioidomycosis are common.
An infection that keeps coming back (or any problems that increase the risk of infection) or have diabetes.
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 (like 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 taking 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 (like TB, bremicadelood 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. 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.
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.

Medication Guide for REMICADE^®

Please read the Medication Guide for REMICADE^® and discuss with your doctor.
(Requires Adobe^® Acrobat^® 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: January 19, 2009