Original ResearchFull Report: Clinical—Alimentary TractMethotrexate in Combination With Infliximab Is No More Effective Than Infliximab Alone in Patients With Crohn's Disease
Section snippets
Materials and Methods
This trial was performed at 15 centers in Canada between December 2005 and February 2008. The investigational review board at each center approved the protocol and all patients provided written informed consent.
Patient Disposition and Characteristics
Supplementary Figure 1 shows the disposition of the study patients. Of the 132 patients who were screened, 126 patients were randomized, with 63 assigned to each treatment group. Six patients withdrew from the study for reasons not related to treatment failure; 2 of these patients were assigned to methotrexate (both patients withdrew because of adverse events) and 4 patients were assigned to placebo (2 patients withdrew consent, 1 patient withdrew because of an adverse event, and 1 patient was
Discussion
We found the combination of methotrexate and infliximab to be no more effective than infliximab alone for inducing and maintaining remission in patients with active CD who were receiving treatment with prednisone. Seventy-six percent of patients assigned to combination therapy achieved prednisone-free remission at the end of 14 weeks of treatment compared with 78% of those who were assigned to infliximab and placebo. Corresponding values for overall treatment success at week 50 were 56% and
Acknowledgments
The authors wish to thank Mrs Beverley Jasevicius for expert secretarial support.
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Author names in bold designate shared co-first authorship.
Conflicts of interest These authors disclose the following: Brian Feagan has received grant/research support from Millennium Pharmaceuticals, Merck, Tillotts Pharma AG, Abbott Labs, Novartis Pharmaceuticals, Centocor, Inc, Elan/Biogen, UCB Pharma, Bristol-Myers Squibb, Genentech, ActoGenix, and Wyeth Pharmaceuticals, Inc; consulting fees from Millennium Pharmaceuticals, Merck, Centocor, Inc, Elan/Biogen, Janssen-Ortho, Teva Pharmaceuticals, Bristol-Myers Squibb, Celgene, UCB Pharma, Abbott Labs, Astra Zeneca, Serono, Genentech, Tillotts Pharma AG, Unity Pharmaceuticals, Albireo Pharma, Given Imaging, Inc, Salix Pharmaceuticals, Novonordisk, GlaxoSmithKline, Actogenix, Prometheus Therapeutics and Diagnostics, Athersys, Axcan, Gilead, Pfizer, Shire, Wyeth, Zealand Pharma, Zyngenia, GiCare Pharma, Inc, Sigmoid Pharma; and has served as a member of the speakers bureau for UCB, Abbott, and J&J/Janssen; John McDonald, Allan Donner, Cindy Wong, Guangyong Zou, Margaret Vandervoort, and Marybeth Hopkins are employees of Robarts Clinical Trials, which was the research organization that conducted this study; Remo Panaccione has received consultant and/or lecture fees from Abbott Laboratories, Amgen, AstraZeneca, Axcan Pharma (now Aptalis), Biogen Idec, Bristol-Myers Squibb, Centocor, ChemoCentryx, Eisai Medical Research, Inc, Elan Pharmaceuticals, Ferring, Genentech, GlaxoSmithKline, Janssen, Merck Sharp and Dohme Corp, Millennium Pharmaceuticals, Inc (now Takeda), Ocera Therapeutics, Inc, Otsuka America Pharmaceutical, Pfizer, Shire Pharmaceuticals, Prometheus Laboratories, Schering-Plough, Synta Pharmaceuticals Corp, Teva, UCB Pharma, and Warner Chilcott; Robert Enns has received research/grant support from Abbvie Canada, Aptalis Pharma, AstraZeneca, Boston Scientific, Bristol Myers Squibb, Cook Canada, Ferring, Janssen Canada Olympus, Pentax, Shire Pharmaceuticals, Takeda, UCB Pharma, Vertex, and Warner-Chilcott; Charles Bernstein has received consultant fees from Abbott Canada, Abbvie Canada, Janssen Canada, Bristol Myers Squibb, and Vertex Pharmaceuticals; and has received research grants from Abbott Canada and Abbvie Canada, and an unrestricted educational grant from Aptalis; Raymond Bourdages has received consultant and/or lecture fees from Abbott Laboratories, Aptalis, Janssen, Shire, Takeda, and Warner-Chilcott; Donald MacIntosh has received consultant and/or lecture feels from Abbott Laboratories, Centocor, and Janssen; Chrystian Dallaire has received consultant and/or lecture fees from Abbott Laboratories, Aptalis, Janssen, Shire, Merck, and Roche; Albert Cohen has received consultant and/or lecture fees from Abbvie, Janssen, and Shire, and educational grants from Abbvie and Janssen; Richard Fedorak has received consultant fees from Abbvie, Centocor, Ferring, Janssen, Shire, and VSL Pharmaceuticals; unrestricted clinical/basic research grants from Abbvie, Alba, Bristol Myers Squibb, Centocor, GlaxoSmithKline, Genentech, Janssen, Merck, Millennium, Novartis, Pfizer, Proctor & Gamble, Roche, and VSL Pharmaceuticals; and is an owner and shareholder in Metablolomic Technologies, Inc; Pierre Paré has received consultant or lecture fees from Abbott Laboratories, Forest Laboratories, Janssen, Novartis, Shire, and Warner-Chilcott; research grants from Abbott Laboratories, Glaxo, Santarus, and Shire; and advisory fees from Abbott Laboratories and Janssen; Alain Bitton has received consultant and/or lecture fees from Abbott Laboratories, Aptalis, Janssen, Shire, Takeda, and Warner-Chilcott; Fred Saibil has received consultancy and/or educational grant support from Abbott Laboratories, Aptalis, Ferring, Inc, Janssen, Shire, and Warner-Chilcott; and Gordon Greenberg has received grant/research support from UCB Pharma, Centocor, Inc, and Millennium Pharmaceuticals; and lecture/consultant fees from Janssen Canada, Merck, Prometheus Laboratories, and Abbott Laboratories.
Funding Supported by the Crohn's and Colitis Foundation of America, Merck/Schering-Plough Canada, and Prometheus Laboratories, Inc.