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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, Erythrodermic Psoriasis

Intervention / Treatment
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* Drug: Infliximab [infliximab biosimilar 3]


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infliximab [infliximab biosimilar 3]<br>Patients with Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis treated by Infliximab BS | Drug: Infliximab [infliximab biosimilar 3]<br>* <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.<br>* Other names: Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions |  | 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 (PASI 75) Response |  | Week 30 | 
| Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infliximab, biosimilar