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NCT03885089 Clinical Trial

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

Psoriasis Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03885089
Other study ID # B5371009
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 21, 2019
Est. completion date March 8, 2024

Study information
Verified date March 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date March 8, 2024
Est. primary completion date March 8, 2024
Accepts healthy volunteers No
Gender All
Age group 0 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Infliximab [infliximab biosimilar 3]
<Psoriasis> 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.

Locations
Country Name City State
Japan Pfizer Local Country Office Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse drug reactions 30 weeks from the day of initial dose
Secondary Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Week 30
Secondary Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Week 30
Secondary Change from Baseline in Body Surface Area (BSA) Baseline, Week 30
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