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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

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. 99;340.

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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