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

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

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 Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Infliximab [infliximab biosimilar 3]

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Pfizer Local Country Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with Rheumatoid Arthritis treated by Infliximab BS

Description

Inclusion Criteria:

• Patients with rheumatoid arthritis who started treatment with this drug
• Patients who received this drug for the first time after the day of launch of this drug.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Infliximab [infliximab biosimilar 3]; Patients with Rheumatoid Arthritis treated by Infliximab BS

Drug: Infliximab [infliximab biosimilar 3]; 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.; Other Names: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Drug Reactions (ADRs)	An ADR was a treatment-related adverse event, and any untoward medical occurrence attributed to Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] in a participant who received this drug. A serious ADR was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; and congenital anomaly/birth defect. Relatedness to Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] was assessed.	30 weeks from the day of initial dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Disease Activity Score Based on 28-joint Count and C-reactive Protein (4 Variables) (DAS28 [4/CRP])	The Disease Activity Score based on 28-joint count and C-reactive protein (DAS28 [4/CRP]) was calculated using four variables: Tender Joint Count (TJC28) and Swollen Joint Count (SJC28), both scored from 0 to 28; participant's overall activity assessed by the Visual Analog Scale (VAS, 0-100 mm); and C-reactive protein (CRP, ≥0 mg/dL). Higher scores indicate increased disease activity. The formula is: DAS28 (4/CRP) = 0.56 × √(TJC28) + 0.28 × √(SJC28) + 0.36 × LN((CRP) × 10 + 1) + 0.014 × (VAS) + 0.96. Changes in DAS28 (4/CRP) from baseline to study completion were summarized as mean ± standard deviation, overall, as well as separately based on prior infliximab use before the initial dose of this drug. Greater negative changes reflect larger reductions in disease activity.	30 weeks from the day of initial dose
Percentage of Participants With Remission (DAS28 [4/CRP])	Percentage of participants with a remission based on DAS28 (4/CRP) was presented along with the two-sided 95% confidence interval (exact method). For participants with available DAS28 (4/CRP) values both at baseline and study completion, the number and proportion of those who achieved remission (<2.3) at both time points were calculated overall, as well as separately based on prior infliximab use before the initial dose of this drug.	30 weeks from the day of initial dose

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2019
• Primary Completion (Actual): November 29, 2024
• Study Completion (Actual): November 29, 2024

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; Infliximab; biosimilar
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Infliximab
• Other Study ID Numbers: B5371006; NCT03885037 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.