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
- Arthritis, Rheumatoid
- Colitis, Ulcerative
- Crohn Disease
- Psoriasis
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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