CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 77 enrolled
Drug / intervention
Infliximab [infliximab biosimilar 3]drug
Likely dose
Infliximab [infliximab biosimilar 3] 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03885037
NCT03885037N/ACompleted

Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Rheumatoid Arthritis)

Pfizer·observational·Posted Mar 21, 2019·Updated Jan 6, 2026

In Brief

An observational study evaluating Infliximab [infliximab biosimilar 3] for Rheumatoid Arthritis. Completed, enrolled 77 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 rheumatoid arthritis under actual status of use.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 21, 2019
Enrollment StartMar 20, 2019
Primary CompletionNov 29, 2024
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 7.3 years ago

Interventions

Infliximab [infliximab biosimilar 3]drug

\<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.