Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Psoriasis)

Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis)

To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis under actual status of use.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris; Pustular Psoriasis; Psoriasis Arthropathica; Erythrodermic Psoriasis
• Intervention / Treatment: Drug: Infliximab [infliximab biosimilar 3]

Detailed Description

This study will be conducted with all-case investigation system in patients with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis.

This study will be conducted in patients who used this drug after the day of approval of dosage and administration for psoriasis at contracted medical institutions. Patients who used this drug before conclusion of the contract with the medical institution will also be included in this study (retrospective patients will be included).

Therefore, Time Perspective is retrospective and prospective.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Pfizer Local Country Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis treated by Infliximab BS

Description

Inclusion Criteria:

• Patients with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who started treatment with this drug
• Patients who received this drug for the first time at the medical institution after the day of launch of this drug.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Infliximab [infliximab biosimilar 3]; Patients with Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis treated by Infliximab BS

Drug: Infliximab [infliximab biosimilar 3]; The usual dose is 5 mg as Infliximab (Genetical Recombination) [Infliximab Biosimilar 3] for every kg of body weight given as an intravenous infusion. After an initial dose is given, the subsequent doses are given at Weeks 2 and 6, and every 8 weeks thereafter. After a dose at Week 6 is given, the dose may be increased or the dosing interval may be reduced for patients who have an incomplete response or reduced effects. These adjustments should be made in a stepwise manner according to condition of patients. The maximum dose is 10 mg for every kg of body weight at the dosing interval of 8 weeks and 6 mg for every kg of body weight at a reduced dosing interval. The minimum dosing interval is 4 weeks.; Other Names: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Drug Reactions	An adverse drug reaction (ADR) was a treatment-related adverse event, and any untoward medical occurrence attributed to Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] in a participant who received this drug. A serious ADR was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] was assessed by the physician.	30 weeks from the day of initial dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response	Percentage of participants with a PASI75 response was presented along with the two-sided 95% confidence interval (exact method). The PASI quantifies the severity of lesions and the percentage of lesion area. It is the total score of the degree of erythema, infiltration/thickening, and scaling (evaluated for each skin finding) in each of the 4 body regions evaluated by the physician. The score was adjusted for the percentage of lesion area of skin rash in each body region and the percentage of the area of each body region to the whole body. The percent change (%) in PASI score from baseline to the study completion date was calculated for each participant, and the number and proportion of participants with ≥ 75% improvement were calculated as PASI75.	30 weeks from the day of initial dose
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response	Percentage of participants with a PASI90 response was presented along with the two-sided 95% confidence interval (exact method). The PASI quantifies the severity of lesions and the percentage of lesion area. It is the total score of the degree of erythema, infiltration/thickening, and scaling (evaluated for each skin finding) in each of the 4 body regions evaluated by the physician. The score was adjusted for the percentage of lesion area of skin rash in each body region and the percentage of the area of each body region to the whole body. The percent change (%) in PASI score from baseline to the study completion date was calculated for each participant, and the number and proportion of participants with ≥ 90% improvement were calculated as PASI90.	30 weeks from the day of initial dose
Change From Baseline in Body Surface Area Involvement (BSA)	Summary statistics of the BSA at baseline, at study completion date, and the change in BSA from baseline to study completion date was presented. BSA was calculated from the percentage of skin rash to body surface area from baseline to study completion date, and change in severity of disease was evaluated.	30 weeks from the day of initial dose

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): October 21, 2019
• Primary Completion (Actual): March 8, 2024
• Study Completion (Actual): March 8, 2024

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Infliximab; biosimilar
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Psoriasis; Arthritis, Psoriatic; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Gastrointestinal Agents; Antirheumatic Agents; Dermatologic Agents; Infliximab
• Other Study ID Numbers: B5371009; NCT03885089 (Registry Identifier: ClinicalTrials.gov)

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.