Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Psoriasis)
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|ClinicalTrials.gov Identifier: NCT03885089|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : December 10, 2019
|Condition or disease||Intervention/treatment|
|Psoriasis Vulgaris Psoriasis Arthropathica Pustular Psoriasis Erythrodermic Psoriasis||Drug: Infliximab [infliximab biosimilar 3]|
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|
|Estimated Enrollment :||100 participants|
|Official Title:||Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis)|
|Actual Study Start Date :||October 21, 2019|
|Estimated Primary Completion Date :||March 13, 2023|
|Estimated Study Completion Date :||March 13, 2023|
Infliximab [infliximab biosimilar 3]
Patients with Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis treated by Infliximab BS
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.
Other Name: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer"
- Incidence of adverse drug reactions [ Time Frame: 30 weeks from the day of initial dose ]
- Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response [ Time Frame: Week 30 ]
- Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response [ Time Frame: Week 30 ]
- Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response [ Time Frame: Week 30 ]
- Change from Baseline in Body Surface Area (BSA) [ Time Frame: Baseline, Week 30 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885089
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|Pfizer Local Country Office||Recruiting|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|