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
Study ID
NCT05796245
Status
Completed

Conditions

Eligibility Criteria

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

Study Details

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.

Key Dates

Start date
Dec 1, 2023
Status verified
Jun 2025
Primary completion
Mar 14, 2024
Completion
Mar 14, 2024

Study Design

Enrollment
2,207 participants (actual)

Arms

  • Arm: Infliximab (Genetical Recombination)[Infliximab Biosimilar 3]
  • Arm: Remicade

Primary Outcome Measure

Incidence Rate of Serious Infections [ Time Frame: From index date up to 60 days after last dose ]

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