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

NCT05796245 | Completed Results

• 2 other identifiers: B5371010NCT05796245
• Study Type: observational
• Target: 2,207
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Tumor Necrosis Factor, TNF; Infliximab; Biosimilar

Outcome Measures

Primary Outcomes (1)

• Incidence Rate of Serious Infections

  The observation of serious infections was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 9 and 232 events occurred with a total of 151.9 and 2609.9 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 5 and 232 events occurred with a total of 22.8 and 2609.9 person-years. For the comparative analysis set (IPTW weighted), 0.5 and 230.7 events occurred with a total of 3.6 and 2598.5 person-years. For the comparative matched analysis set, 5 and 6 events occurred with a total of 22.8 and 46.7 person-years.

  From index date up to 60 days after last dose

Secondary Outcomes (4)

• 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 the first incident event, death, end of the study period, or loss to follow-up

Study Arms (2)

Infliximab (Genetical Recombination)[Infliximab Biosimilar 3]

Remicade

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• years of age or older at the time of index date

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Tokyo, Japan

Location

Related Links

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

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Skin Diseases, Papulosquamous; Skin Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: April 3, 2023
• Study Start: December 1, 2023
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: June 4, 2025
• Results First Posted: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)