"Infliximab Biosimilar Pfizer Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)"

CompletedOBSERVATIONAL
Enrollment

428

Participants

Timeline

Start Date

March 18, 2019

Primary Completion Date

February 2, 2024

Study Completion Date

February 2, 2024

Conditions
Crohn's DiseaseUlcerative Colitis
Interventions
DRUG

Infliximab [infliximab biosimilar 3]

\<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.

Trial Locations (1)

Unknown

Pfizer Local Country Office, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY