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

Study Overview
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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.

Official Title
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Infliximab-Pfizer Biosimilar Post-Marketing Database Study

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

Participation Criteria
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Eligibility Criteria
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Inclusion criteria Have at least 90 days of look-back period 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. 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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infliximab (Genetical Recombination)[Infliximab Biosimilar 3]<br> | |
| Remicade<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of Serious infections |  | From index date up to 60 days after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of tuberculosis |  | From index date up to 60 days after last dose | 
| 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 malignancy |  | From index date up to maximum of 5 years (the end of the study period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tumor Necrosis Factor, TNF, Infliximab, Biosimilar