A Study to Learn About the Study Medicine Called Infliximab (Genetical Recombination)[Infliximab Biosimilar 3] in People With Rheumatoid Arthritis, Ulcerative Colitis, Crohn's Disease, or Psoriasis

Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05796245
Collaborator
(none)
1,000
2.9

Study Details

Study Description

Brief Summary

The purpose of this study is to learn about the safety of the safety of the study medicine called infliximab for the possible treatment of rheumatoid arthritis (RA), ulcerative colitis (UC, Crohn's disease, or psoriasis.

RA is a kind of joint disease that causes pain and swelling.

UC causes inflammation and sores (also called ulcers), in the lining of the rectum and colon.

Chron's disease is a disease that lasts for a long time and causes severe irritation in your digestive tract.

Psoriasis is a skin disease that gives you a dry, scaly rash.

The study includes patient's data from the database who:
  • Have at least 90 days of look-back period

  • Have any of these diseases (RA, UC, Crohn's disease, or Psoriasis) in the 90-day look back period

  • Are 15 years of age or older at the time of first dosing

All the patient's data included in this study would have received infliximab as intravenous (into veins) injection.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Infliximab-Pfizer Biosimilar Post-Marketing Database Study
    Anticipated Study Start Date :
    Dec 1, 2023
    Anticipated Primary Completion Date :
    Feb 28, 2024
    Anticipated Study Completion Date :
    Feb 28, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Infliximab (Genetical Recombination)[Infliximab Biosimilar 3]

    Remicade

    Outcome Measures

    Primary Outcome Measures

    1. Incidence rate of Serious infections [From index date up to 60 days after last dose]

    Secondary Outcome Measures

    1. Incidence rate of tuberculosis [From index date up to 60 days after last dose]

    2. Incidence rate of serious blood disorder [From index date up to 60 days after last dose]

    3. Incidence rate of interstitial pneumonia [From index date up to 60 days after last dose]

    4. Incidence rate of malignancy [From index date up to maximum of 5 years (the end of the study period)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion criteria

    1. Have at least 90 days of look-back period

    2. Have diagnostic code of indicated diseases (rheumatoid arthritis, ulcerative colitis, Crohn's disease, or psoriasis) in the 90-day look-back period. Patients with >1 indication will be summarized as a separate group from each sub-cohort. An inpatient or outpatient visit assigned a diagnosis code consistent with either rheumatoid arthritis, ulcerative colitis, Crohn's disease, or psoriasis using ICD-10 coding.

    3. 15 years of age or older at the time of index date

    Exclusion criteria

    1. Patients with pre-existing safety outcome event during the 90-day look-back period will be excluded from the study cohort for that specific outcome event as this study is observing incident cases.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT05796245
    Other Study ID Numbers:
    • B5371010
    First Posted:
    Apr 3, 2023
    Last Update Posted:
    Apr 3, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Pfizer
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 3, 2023