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NCT03885037 Clinical Trial

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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03885037
Other study ID # B5371006
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 20, 2019
Est. completion date February 20, 2025

Study information
Verified date April 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 74
Est. completion date February 20, 2025
Est. primary completion date February 20, 2025
Accepts healthy volunteers No
Gender All
Age group 0 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Japan Pfizer Local Country Office Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse drug reactions 30 weeks from the day of initial dose
Secondary Disease Activity Score Based on 28-joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) Week 30
Secondary Percentage of Participants With Remission (DAS28-4[CRP]) Baseline, Week30
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