drugset / Trial / NCT01346826
Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)
RandomizedParallel-groupDouble-blindTreatment
Summary
This study aims to test the hypothesis that the accelerated infusion of infliximab is not inferior to the conventional 2 hour infusion with respect to the frequency of infusion reaction.
Timeline
- Start
- 2011-05
- Primary completion
- 2015-10
- Completion
- 2016-04
Publications
- Background Clare DF, Alexander FC, Mike S, Dan G, Allan F, Lisa W, Peter HJ. Accelerated infliximab infusions are safe and well tolerated in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2009 Jan;21(1):71-5. doi: 10.1097/MEG.0b013e3283081afe.
- Background Van Assche G, Vermeire S, Noman M, Amant C, Weyts E, Vleminckx A, Vermeyen MJ, Rutgeerts P. Infliximab administered with shortened infusion times in a specialized IBD infusion unit: a prospective cohort study. J Crohns Colitis. 2010 Sep;4(3):329-33. doi: 10.1016/j.crohns.2009.12.012. Epub 2010 Jan 18.
- Background Bhat S, Sharma D, Doherty P, Tham TC, Caddy GR. Are accelerated infliximab infusions safe in patients with inflammatory bowel disease? Inflamm Bowel Dis. 2010 Nov;16(11):1922-5. doi: 10.1002/ibd.21279.
- Background Breynaert C, Ferrante M, Fidder H, Van Steen K, Noman M, Ballet V, Vermeire S, Rutgeerts P, Van Assche G. Tolerability of shortened infliximab infusion times in patients with inflammatory bowel diseases: a single-center cohort study. Am J Gastroenterol. 2011 Apr;106(4):778-85. doi: 10.1038/ajg.2011.61. Epub 2011 Mar 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Infliximab | Monoclonal antibody | 5 mg/kg | — |