NCT01346826 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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.
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.
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.

Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial

Clinical trial NCT01346826 - References