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| ID | Type | Description | Link |
|---|---|---|---|
| NCT03885089 | Registry Identifier | ClinicalTrials.gov |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infliximab [infliximab biosimilar 3] | Patients with Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis treated by Infliximab BS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab [infliximab biosimilar 3] | Drug | <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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 weeks from the day of initial dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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Patients with Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis treated by Infliximab BS
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Local Country Office | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | Participants with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who received Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | Participants with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who received Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The safety analysis set (8 participants) comprised of participants who satisfied the inclusion criteria and had received Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]. Participants with no informed consent for publication of study results were excluded. | Posted | Count of Participants | Participants | 30 weeks from the day of initial dose |
|
30 weeks from the day of initial dose
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both events during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | Participants with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who received Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA/J26.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 18, 2022 | Feb 6, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 25, 2023 | Feb 6, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
|
| 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. | 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. | 30 weeks from the day of initial dose |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG000 | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | Participants with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who received Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion. |
|
|
| Secondary | 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. | The efficacy analysis set (4 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 4 participants, percentage of participants with a PASI75 response as of the study completion date was calculated for the 3 participants whose PASI scores both at baseline and study completion date were available. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 30 weeks from the day of initial dose |
|
|
|
| Secondary | 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. | The efficacy analysis set (4 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 4 participants, percentage of participants with a PASI90 response as of the study completion date was calculated for the 3 participants whose PASI scores both at baseline and study completion date were available. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 30 weeks from the day of initial dose |
|
|
|
| Secondary | 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. | The efficacy analysis set (4 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 4 participants, summary statistics and change from baseline in BSA as of the study completion date was calculated for the 1 participant whose BSA both at baseline and study completion date were available. | Posted | Mean | Standard Deviation | Percentage of BSA | 30 weeks from the day of initial dose |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 3 |
| 8 |
| Headache | Nervous system disorders | MedDRA/J26.1 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA/J26.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA/J26.1 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA/J26.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Change |
|