A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Active Ulcerative Colitis

Summary

The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Ulcerative Colitis.

Timeline

Start

2002-02

Primary completion

—

Completion

2007-01

Outcome

Met primary endpoint

paper clinical response at week 8, as compared with 37 percent of those who received placebo (P<0.001 for both comparisons with placebo). PMID 16339095 ↗

Publications

• Results Feagan BG, Reinisch W, Rutgeerts P, Sandborn WJ, Yan S, Eisenberg D, Bala M, Johanns J, Olson A, Hanauer SB. The effects of infliximab therapy on health-related quality of life in ulcerative colitis patients. Am J Gastroenterol. 2007 Apr;102(4):794-802. doi: 10.1111/j.1572-0241.2007.01094.x. Epub 2007 Feb 23.
• Results Reinisch W, Sandborn WJ, Bala M, Yan S, Feagan BG, Rutgeerts P, Radford-Smith G, Xu S, Eisenberg D, Olson A, Colombel JF. Response and remission are associated with improved quality of life, employment and disability status, hours worked, and productivity of patients with ulcerative colitis. Inflamm Bowel Dis. 2007 Sep;13(9):1135-40. doi: 10.1002/ibd.20165.
• Results Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. doi: 10.1056/NEJMoa050516.
• Wong ECL, Jairath V, Dulai PS, Marshall JK, Ma C, Reinisch W, Narula N. Infliximab and Upadacitinib Demonstrate Superior Early Onset of Efficacy in Biologic-Naive Ulcerative Colitis With Severe Endoscopic Disease. Am J Gastroenterol. 2026 Feb 2. doi: 10.14309/ajg.0000000000003940. Online ahead of print.
• Adedokun OJ, Sandborn WJ, Feagan BG, Rutgeerts P, Xu Z, Marano CW, Johanns J, Zhou H, Davis HM, Cornillie F, Reinisch W. Association between serum concentration of infliximab and efficacy in adult patients with ulcerative colitis. Gastroenterology. 2014 Dec;147(6):1296-1307.e5. doi: 10.1053/j.gastro.2014.08.035. Epub 2014 Aug 28.
• Sandborn WJ, Rutgeerts P, Feagan BG, Reinisch W, Olson A, Johanns J, Lu J, Horgan K, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab. Gastroenterology. 2009 Oct;137(4):1250-60; quiz 1520. doi: 10.1053/j.gastro.2009.06.061. Epub 2009 Jul 28.

Drugs

Indications