Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Psoriasis)
NCT ID: NCT03885089
Last Updated: 2025-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
10 participants
OBSERVATIONAL
2019-10-21
2024-03-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
OTHER
Study Groups
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Infliximab [infliximab biosimilar 3]
Patients with Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis treated by Infliximab BS
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who received this drug for the first time at the medical institution after the day of launch of this drug.
0 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Local Country Office
Tokyo, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT03885089
Identifier Type: REGISTRY
Identifier Source: secondary_id
B5371009
Identifier Type: -
Identifier Source: org_study_id
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