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

Completed

• Conditions: Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Psoriasis

• Registration Number: NCT05796245
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-31
• Study First Posted: 2023-04-03
• Study Start: 2023-12-01
• Primary Completion: 2024-03-14
• Study Completion: 2024-03-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of Serious infections	From index date up to 60 days after last dose

Secondary Outcome Measures

Name	Time	Method
Incidence rate of malignancy	From index date up to maximum of 5 years (the end of the study period)
Incidence rate of serious blood disorder	From index date up to 60 days after last dose
Incidence rate of interstitial pneumonia	From index date up to 60 days after last dose
Incidence rate of tuberculosis	From index date up to 60 days after last dose

Trial Locations

Locations (1)

Pfizer; 🇯🇵 Tokyo, Japan