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

Sponsor
Pfizer
Study ID
NCT06790420
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab Pfizer — DRUG
    For the acute therapy, Rituximab is administrated once a week up to 8 times and for maintenance therapy, it is administrated every 8 weeks up to 12 times
  • Rituxan — DRUG
    For the acute therapy, Rituximab is administrated once a week up to 8 times and for maintenance therapy, it is administrated every 8 weeks up to 12 times

Study Details

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

Key Dates

Start date
Jan 31, 2025
Status verified
Apr 2026
Primary completion
Mar 14, 2025
Completion
Mar 14, 2025

Study Design

Enrollment
2,703 participants (actual)

Arms

  • Arm: Exposed group
    patients treated with Rituximab Pfizer
  • Arm: Comparative group
    patients treated with Rituxan

Primary Outcome Measure

Incidence of Infections Which Requires Procedures, Medication or Hospitalization [ Time Frame: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period) ]

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