Clinical trial NCT05796245: 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
Official title: Infliximab-Pfizer Biosimilar Post-Marketing Database Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Colitis, Ulcerative
Crohn Disease
Psoriasis
Keywords: Tumor Necrosis Factor, TNF
Infliximab
Biosimilar
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 2207
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes individuals who have a diagnosis of rheumatoid arthritis, ulcerative colitis, Crohn's disease, or psoriasis and have been exposed to Infliximab-Pfizer Biosimilar or the innovator (Remicade) with a planned study period between December 1, 2018 and November 30, 2023.

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.


Eligibility criteria: Inclusion criteria

1. Have at least 90 days of look-back period
2. 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.
3. 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.

Primary outcomes:
measure: Incidence Rate of Serious Infections
timeFrame: From index date up to 60 days after last dose
Secondary outcomes:
measure: Incidence Rate of Tuberculosis
timeFrame: From index date up to 60 days after last dose
measure: Incidence Rate of Serious Blood Disorder
timeFrame: From index date up to 60 days after last dose
measure: Incidence Rate of Interstitial Pneumonia
timeFrame: From index date up to 60 days after last dose
measure: Incidence Rate of Malignancy
timeFrame: From index date up to the first incident event, death, end of the study period, or loss to follow-up
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: