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 Type
OBSERVATIONAL
Enrollment
77
\<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.
Pfizer Local Country Office
Tokyo, Japan
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.
Time frame: 30 weeks from the day of initial dose
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.
Time frame: 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.
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Time frame: 30 weeks from the day of initial dose