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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
NCT03885089 |
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Date of registration:
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04/03/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Psoriasis)
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Scientific 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) |
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Date of first enrolment:
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October 21, 2019 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03885089 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Japan
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion 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.
Age minimum:
0 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pustular Psoriasis
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Psoriasis Vulgaris
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Erythrodermic Psoriasis
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Psoriasis Arthropathica
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Intervention(s)
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Drug: Infliximab [infliximab biosimilar 3]
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Primary Outcome(s)
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Incidence of adverse drug reactions
[Time Frame: 30 weeks from the day of initial dose]
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Secondary Outcome(s)
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Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response
[Time Frame: Week 30]
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Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response
[Time Frame: Week 30]
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Change from Baseline in Body Surface Area (BSA)
[Time Frame: Baseline, Week 30]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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