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

Psoriasis Clinical Trial

Official title:

Infliximab-Pfizer Biosimilar Post-Marketing Database Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05796245
• Other study ID #: B5371010
• Status: Completed
• Start date: December 1, 2023
• Est. completion date: March 14, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 14, 2024
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Psoriasis
• Ulcer

Locations

Country	Name	City	State
Japan	Pfizer	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of Serious infections		From index date up to 60 days after last dose
Secondary	Incidence rate of tuberculosis		From index date up to 60 days after last dose
Secondary	Incidence rate of serious blood disorder		From index date up to 60 days after last dose
Secondary	Incidence rate of interstitial pneumonia		From index date up to 60 days after last dose
Secondary	Incidence rate of malignancy		From index date up to maximum of 5 years (the end of the study period)

External Links

•   To obtain contact information for a study center near you, click here.