An observational study in Psoriasis Vulgaris, Psoriasis Arthropathica and Pustular Psoriasis, sponsored by Pfizer. Completed at 1 site in Japan. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by Pfizer · 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.
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.
579 studies on the registry are indexed under Arthritis, Psoriatic; 132 are open to participants now.
This study's enrollment of 10 is below the median of 300 across 235 observational studies indexed under Arthritis, Psoriatic.
Browse Arthritis, Psoriatic studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis treated by Infliximab BS
Inclusion Criteria:
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.
Also known as: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer"
Number of Participants With Adverse Drug Reactions
An adverse drug reaction (ADR) was a treatment-related adverse event, and any untoward medical occurrence attributed to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] in a participant who received this drug. A serious ADR was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] was assessed by the physician.
Time frame: 30 weeks from the day of initial dose
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response
Percentage of participants with a PASI75 response was presented along with the two-sided 95% confidence interval (exact method). The PASI quantifies the severity of lesions and the percentage of lesion area. It is the total score of the degree of erythema, infiltration/thickening, and scaling (evaluated for each skin finding) in each of the 4 body regions evaluated by the physician. The score was adjusted for the percentage of lesion area of skin rash in each body region and the percentage of the area of each body region to the whole body. The percent change (%) in PASI score from baseline to the study completion date was calculated for each participant, and the number and proportion of participants with ≥ 75% improvement were calculated as PASI75.
Time frame: 30 weeks from the day of initial dose
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response
Percentage of participants with a PASI90 response was presented along with the two-sided 95% confidence interval (exact method). The PASI quantifies the severity of lesions and the percentage of lesion area. It is the total score of the degree of erythema, infiltration/thickening, and scaling (evaluated for each skin finding) in each of the 4 body regions evaluated by the physician. The score was adjusted for the percentage of lesion area of skin rash in each body region and the percentage of the area of each body region to the whole body. The percent change (%) in PASI score from baseline to the study completion date was calculated for each participant, and the number and proportion of participants with ≥ 90% improvement were calculated as PASI90.
Time frame: 30 weeks from the day of initial dose
Change From Baseline in Body Surface Area Involvement (BSA)
Summary statistics of the BSA at baseline, at study completion date, and the change in BSA from baseline to study completion date was presented. BSA was calculated from the percentage of skin rash to body surface area from baseline to study completion date, and change in severity of disease was evaluated.
Time frame: 30 weeks from the day of initial dose
| Milestone | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] |
|---|---|
| Started | 10 |
| Completed | 8 |
| Not completed | 2 |
| Withdrew: No informed consent for publication of study results | 2 |
An adverse drug reaction (ADR) was a treatment-related adverse event, and any untoward medical occurrence attributed to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] in a participant who received this drug. A serious ADR was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] was assessed by the physician.
| Participants | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] |
|---|---|
| Number of Participants With Adverse Drug Reactions | 2 |
Percentage of participants with a PASI75 response was presented along with the two-sided 95% confidence interval (exact method). The PASI quantifies the severity of lesions and the percentage of lesion area. It is the total score of the degree of erythema, infiltration/thickening, and scaling (evaluated for each skin finding) in each of the 4 body regions evaluated by the physician. The score was adjusted for the percentage of lesion area of skin rash in each body region and the percentage of the area of each body region to the whole body. The percent change (%) in PASI score from baseline to the study completion date was calculated for each participant, and the number and proportion of participants with ≥ 75% improvement were calculated as PASI75.
| Percentage of Participants | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] |
|---|---|
| Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | 0.0 (0.00 to 70.76) |
Percentage of participants with a PASI90 response was presented along with the two-sided 95% confidence interval (exact method). The PASI quantifies the severity of lesions and the percentage of lesion area. It is the total score of the degree of erythema, infiltration/thickening, and scaling (evaluated for each skin finding) in each of the 4 body regions evaluated by the physician. The score was adjusted for the percentage of lesion area of skin rash in each body region and the percentage of the area of each body region to the whole body. The percent change (%) in PASI score from baseline to the study completion date was calculated for each participant, and the number and proportion of participants with ≥ 90% improvement were calculated as PASI90.
| Percentage of Participants | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] |
|---|---|
| Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | 0.0 (0.00 to 70.76) |
Summary statistics of the BSA at baseline, at study completion date, and the change in BSA from baseline to study completion date was presented. BSA was calculated from the percentage of skin rash to body surface area from baseline to study completion date, and change in severity of disease was evaluated.
| Percentage of BSA | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] |
|---|---|
| At baseline | 0.00 ± NA |
| At study completion date | 30.00 ± NA |
| Change | 30.00 ± NA |
Collected over 30 weeks from the day of initial dose. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | 0/8 (0%) | 0/8 (0%) | 3/8 (37.5%) |
| Event | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] |
|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/8 |
| HeadacheNervous system disorders | 1/8 |
| Drug eruptionSkin and subcutaneous tissue disorders | 1/8 |
| Dry skinSkin and subcutaneous tissue disorders | 1/8 |
| PsoriasisSkin and subcutaneous tissue disorders | 1/8 |
A total of 10 participants were enrolled in this study. Of the 10 participants from whom case report forms were collected, 2 participants were excluded from the safety analysis set due to no informed consent for publication of study results.
| Age, Customized(Participants) | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] |
|---|---|
| <15 years | 0 |
| ≥15 and <65 years | 5 |
| ≥65 years | 3 |
| Sex: Female, Male(Participants) | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] |
|---|---|
| Female | 2 |
| Male | 6 |
| Race and Ethnicity Not Collected(Participants) | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] |
|---|
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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