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

Completed

• Conditions: Psoriasis Arthropathica; Pustular Psoriasis; Erythrodermic Psoriasis; Psoriasis Vulgaris
• Interventions: Drug: Infliximab [infliximab biosimilar 3]

• Registration Number: NCT03885089
• Lead Sponsor: Pfizer

Brief 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.

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 Timeline

• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Study Start: 2019-10-21
• Status Verified: 2024-03
• Primary Completion: 2024-03-08
• Study Completion: 2024-03-08
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions	30 weeks from the day of initial dose

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response	Week 30
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response	Week 30
Change from Baseline in Body Surface Area (BSA)	Baseline, Week 30

Trial Locations

Locations (1)

Pfizer Local Country Office; 🇯🇵 Tokyo, Japan