RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] Post-marketing Database Study

Completed

• Conditions: Lymphoma
• Interventions: Drug: Rituximab Pfizer; Drug: Rituxan

• Registration Number: NCT06790420
• Lead Sponsor: Pfizer

Brief Summary

To evaluate the incidence of the outcomes for the safety specifications in patients of Medical Data Vision database in Japan diagnosed with CD20 positive B-cell non- Hodgkin's lymphoma who were treated with Rituximab Pfizer to compare it with outcomes in patients who were treated with Rituxan from 01 January 2020 through 31 December 2024

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-21
• Study First Posted: 2025-01-24
• Study Start: 2025-01-31
• Primary Completion: 2025-03-14
• Study Completion: 2025-03-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1. Have prescription of Rituximab Pfizer or Rituxan within the enrollment period (Index Date: first prescription date within the enrollment period).
2. Have diagnosis of CD20 positive B-cell non- Hodgkin's lymphoma on the index month or within 6 months before index date
3. Have at least 6 months of Look back period and at least one medical record prior to 7 months before the Index date.
4. Have not prescription of Rituximab product before index date(Comparative Analysis Set only).

Exclusion Criteria

1. Have any diagnosis of other indications of rituximab products other than CD20 positive B-cell non- Hodgkin's lymphoma before index date .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed group	Rituximab Pfizer	patients treated with Rituximab Pfizer
Comparative group	Rituxan	patients treated with Rituxan

Primary Outcome Measures

Name	Time	Method
Incidence of infections which requires procedures, medication or hospitalization	From index date up to 180 days after last dose	until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up or the end of study period

Secondary Outcome Measures

Name	Time	Method
Incidence of 'pancytopenia, leukocytopenia, Neutropenia, agranulocytosis, thrombocytopenia'	From index date up to 180 days after last dose	until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up or the end of study period
Incidence of Infusion reactions	From index date up to next day after last dose	until the first incidence of an event, date of switch to another Rituximab product, the end of risk window which is until next day after last dose, death, or the end of study period.
Incidence of hepatic function disorder, jaundice	From index date up to 180 days after last dose	until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up or the end of study period
Incidence of cardiac disorder	From index date up to 180 days after last dose	until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up or the end of study period
Incidence of gastrointestinal perforation/obstruction	From index date up to 180 days after last dose	until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up or the end of study period
Incidence of hypotension	From index date up to next day after last dose	until the first incidence of an event, date of switch to another Rituximab product, the end of risk window which is until next day after last dose, death, or the end of study period.
Incidence of development of malignant tumor	From index date up to maximum of 5 years (the end of the study period)	follow until the first incident event, death, end of the study period, or loss to follow up

Trial Locations

Locations (1)

Pfizer; 🇯🇵 Tokyo, Japan