A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease

Summary

A study of infliximab in patients with Fistulizing Crohn's Disease

Timeline

Start

2000-06

Primary completion

—

Completion

2006-08

Outcome

Met primary endpoint

paper The time to loss of response was significantly longer for patients who received infliximab maintenance therapy than for those who received placebo maintenance PMID 14985485 ↗

paper more than 40 weeks vs. 14 weeks, P<0.001 PMID 14985485 ↗

Publications

• Results Sands BE, Blank MA, Patel K, van Deventer SJ; ACCENT II Study. Long-term treatment of rectovaginal fistulas in Crohn's disease: response to infliximab in the ACCENT II Study. Clin Gastroenterol Hepatol. 2004 Oct;2(10):912-20. doi: 10.1016/s1542-3565(04)00414-8.
• Results Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85. doi: 10.1056/NEJMoa030815.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Infliximab	Monoclonal antibody	5 mg/kg	Intravenous

Indications