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

NCT ID: NCT05796245

Last Updated: 2025-06-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-03-14

Brief Summary

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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.

Detailed Description

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Conditions

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Arthritis, Rheumatoid Colitis, Ulcerative Crohn Disease Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Infliximab (Genetical Recombination)[Infliximab Biosimilar 3]

No interventions assigned to this group

Remicade

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer

Tokyo, , Japan

Site Status

Countries

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Japan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B5371010

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

Other Identifiers

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NCT05796245

Identifier Type: REGISTRY

Identifier Source: secondary_id

B5371010

Identifier Type: -

Identifier Source: org_study_id

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