Psoriasis Vulgaris Clinical Trial
Official title:
Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis)
NCT number | NCT03885089 |
Other study ID # | B5371009 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 21, 2019 |
Est. completion date | March 8, 2024 |
Verified date | March 2024 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis under actual status of use.
Status | Completed |
Enrollment | 10 |
Est. completion date | March 8, 2024 |
Est. primary completion date | March 8, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Japan | Pfizer Local Country Office | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse drug reactions | 30 weeks from the day of initial dose | ||
Secondary | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response | Week 30 | ||
Secondary | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response | Week 30 | ||
Secondary | Change from Baseline in Body Surface Area (BSA) | Baseline, Week 30 |
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