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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03885089
Date of registration: 04/03/2019
Prospective Registration: Yes
Primary sponsor: Pfizer
Public title: Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Psoriasis)
Scientific title: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis)
Date of first enrolment: October 21, 2019
Target sample size: 100
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03885089
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Japan
Contacts
Name:     Pfizer CT.gov Call Center
Address: 
Telephone: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Affiliation: 
Name:     Pfizer CT.gov Call Center
Address: 
Telephone:
Email:
Affiliation:  Pfizer
Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Erythrodermic Psoriasis
Psoriasis Arthropathica
Psoriasis Vulgaris
Pustular Psoriasis
Intervention(s)
Drug: Infliximab [infliximab biosimilar 3]
Primary Outcome(s)
Incidence of adverse drug reactions [Time Frame: 30 weeks from the day of initial dose]
Secondary Outcome(s)
Change from Baseline in Body Surface Area (BSA) [Time Frame: Baseline, 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 75 (PASI 75) Response [Time Frame: Week 30]
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response [Time Frame: Week 30]
Secondary ID(s)
B5371009
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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