At a glance
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Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Crohn's Disease or Ulcerative Colitis)
In Brief
An observational study evaluating Infliximab [infliximab biosimilar 3] for Crohn's Disease and Ulcerative Colitis. Completed, enrolled 428 participants across 1 site.
Detailed Summary
To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against Crohn's disease or ulcerative colitis under actual status of use.
Study Details
Timeline
Interventions
\<Crohn's disease\> The usual dose is 5 mg as Infliximab \[Infliximab Biosimilar 3\] for every kg of body weight given as an intravenous infusion. After an initial dose is given, the subsequent doses are given at Weeks 2 and 6, and every 8 weeks thereafter. After a dose at Week 6 is given, the dose may be increased or the dosing interval may be reduced for patients who have reduced effects. At an increased dose, the dose may be adjusted to 10 mg for every kg of body weight. At a reduced dosing interval, the dose of 5 mg for every kg of body weight may be given at the minimum dosing interval of 4 weeks. \<Ulcerative colitis\> The usual dose is 5 mg as Infliximab \[Infliximab Biosimilar 3\] for every kg of body weight given as an intravenous infusion. After an initial dose is given, the subsequent doses are given at Weeks 2 and 6, and every 8 weeks thereafter.