"Infliximab Biosimilar for Intravenous Drip Infusion 100 mg Pfizer Drug Use Investigation (Rheumatoid Arthritis)"

CompletedOBSERVATIONAL
Enrollment

77

Participants

Timeline

Start Date

March 20, 2019

Primary Completion Date

November 29, 2024

Study Completion Date

November 29, 2024

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Infliximab [infliximab biosimilar 3]

\<Rheumatoid arthritis\> The usual dose is 3 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 an incomplete response or reduced effects. These adjustments should be made in a stepwise manner. The maximum dose is 10 mg for every kg of body weight at the dosing interval of 8 weeks and 6 mg for every kg of body weight at a reduced dosing interval. The minimum dosing interval is 4 weeks. This drug should be given in combination with methotrexate.

Trial Locations (1)

Unknown

Pfizer Local Country Office, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT03885037 - "Infliximab Biosimilar for Intravenous Drip Infusion 100 mg Pfizer Drug Use Investigation (Rheumatoid Arthritis)" | Biotech Hunter | Biotech Hunter