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

NCT06790420 | Completed Results

• 1 other identifier: B3281009
• Study Type: observational
• Target: 2,703
• Locations: 1 country
• Sites: 1

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

Conditions

Lymphoma

Keywords

Lymphoma; Rituximab; Infection

Outcome Measures

Primary Outcomes (1)

• Incidence of Infections Which Requires Procedures, Medication or Hospitalization

  Infection was expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued 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 (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted.

  From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)

Secondary Outcomes (7)

• Incidence of 'Pancytopenia, Leukocytopenia, Neutropenia, Agranulocytosis, Thrombocytopenia' (Cytopenias)

  From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)

• Incidence of Infusion Reactions

  From index date up to next day after last dose, with a maximum of 5 years (the end of the study period)

• Incidence of Hepatic Function Disorder (HFD), Jaundice

  From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)

• Incidence of Cardiac Disorder

  From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)

• Incidence of Gastrointestinal (GI) Perforation/Obstruction

  From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)

Study Arms (2)

Exposed group

patients treated with Rituximab Pfizer

Drug: Rituximab Pfizer

Comparative group

patients treated with Rituxan

Drug: Rituxan

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

Exposed group

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

Comparative group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population includes individuals who have a diagnosis of CD20 positive B-cell non- Hodgkin's lymphoma and treated with Rituximab Pfizer and Rituxan

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Tokyo, Japan

Location

Related Links

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

MeSH Terms

Conditions

Lymphoma; Infections

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 24, 2025
• Study Start: January 31, 2025
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: May 15, 2026
• Results First Posted: May 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)