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NCT05796245Completed

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

Infliximab-Pfizer Biosimilar Post-Marketing Database Study

Source: ClinicalTrials.gov · Last updated 4 Jun 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
2207 (actual)
First submitted
2 Mar 2023
Start date
1 Dec 2023
Primary completion date
14 Mar 2024
Lead sponsor
Pfizer
NCT number
NCT05796245

What you commit to

  • Study type: Observational
  • Participants enrolled: 2207
  • From 1 Dec 2023 to the primary completion date, 14 Mar 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

  • 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

Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pfizer
Coordinator of this site? Confirm its status
TokyoJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.