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

NCT03885037 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 77

Last updated 2026-01-06

Study results available
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Summary

To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against rheumatoid arthritis under actual status of use.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2024-11-29
Completion
2024-11-29

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03885037 on ClinicalTrials.gov