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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid; Psoriasis; Crohn Disease; Colitis, Ulcerative

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Infliximab (Genetical Recombination)[Infliximab Biosimilar 3]
Remicade

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): March 14, 2024
• Study Completion (Actual): March 14, 2024

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Infliximab; Biosimilar; Tumor Necrosis Factor, TNF
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Skin Diseases; Immune System Diseases; Autoimmune Diseases; Gastrointestinal Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Skin Diseases, Papulosquamous; Inflammatory Bowel Diseases; Ulcer; Arthritis; Arthritis, Rheumatoid; Psoriasis; Crohn Disease; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: B5371010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.