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 : March 17, 2023
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|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 12, 2025|
|Estimated Study Completion Date :||March 12, 2025|
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||0 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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.
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|
|Other Study ID Numbers:||
|First Posted:||March 21, 2019 Key Record Dates|
|Last Update Posted:||March 17, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.|
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