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| ID | Type | Description | Link |
|---|---|---|---|
| NCT05796245 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to learn about the safety of the safety of the study medicine called infliximab for the possible treatment of rheumatoid arthritis (RA), ulcerative colitis (UC, Crohn's disease, or psoriasis.
RA is a kind of joint disease that causes pain and swelling.
UC causes inflammation and sores (also called ulcers), in the lining of the rectum and colon.
Chron's disease is a disease that lasts for a long time and causes severe irritation in your digestive tract.
Psoriasis is a skin disease that gives you a dry, scaly rash.
The study includes patient's data from the database who:
All the patient's data included in this study would have received infliximab as intravenous (into veins) injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infliximab (Genetical Recombination)[Infliximab Biosimilar 3] | |||
| Remicade |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Serious Infections | The observation of serious infections was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 9 and 232 events occurred with a total of 151.9 and 2609.9 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 5 and 232 events occurred with a total of 22.8 and 2609.9 person-years. For the comparative analysis set (IPTW weighted), 0.5 and 230.7 events occurred with a total of 3.6 and 2598.5 person-years. For the comparative matched analysis set, 5 and 6 events occurred with a total of 22.8 and 46.7 person-years. | From index date up to 60 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Tuberculosis | The observation of tuberculosis was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 0 and 14 events occurred with a total of 161.8 and 2904.1 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 0 and 14 events occurred with a total of 27.2 and 2904.1 person-years. For the comparative analysis set (IPTW weighted), 0.0 and 14.3 events occurred with a total of 10.4 and 2889.7 person-years. For the comparative matched analysis set, 0 and 1 event occurred with a total of 27.2 and 50.1 person-years. |
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Inclusion criteria
Exclusion criteria
1. Patients with pre-existing safety outcome event during the 90-day look-back period will be excluded from the study cohort for that specific outcome event as this study is observing incident cases.
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The study population includes individuals who have a diagnosis of rheumatoid arthritis, ulcerative colitis, Crohn's disease, or psoriasis and have been exposed to Infliximab-Pfizer Biosimilar or the innovator (Remicade) with a planned study period between December 1, 2018 and November 30, 2023.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | 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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Data of study patients were extracted from the Medical Data Vision (MDV) database according to the study entry criteria. MDV database is a hospital-based claims database in Japan that consists of outpatient and inpatient data from hospitals using the diagnosis procedure combination system. The study period was from December 1, 2018 through November 30, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Patients treated with Infliximab-Pfizer Biosimilar who meet the inclusion/exclusion criteria. |
| FG001 | Remicade (Infliximab [Genetical Recombination]) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jun 28, 2024 | Feb 20, 2025 |
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| From index date up to 60 days after last dose |
| Incidence Rate of Serious Blood Disorder | The observation of serious blood disorder was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 1 and 15 events occurred with a total of 163.5 and 2913.5 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 1 and 15 events occurred with a total of 27.5 and 2913.5 person-years. For the comparative analysis set (IPTW weighted), 0.1 and 14.9 events occurred with a total of 10.4 and 2899.6 person-years. For the comparative matched analysis set, 1 and 0 events occurred with a total of 27.5 and 52.5 person-years. | From index date up to 60 days after last dose |
| Incidence Rate of Interstitial Pneumonia | The observation of interstitial pneumonia was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 5 and 42 events occurred with a total of 157.1 and 2918.8 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 1 and 42 events occurred with a total of 26.2 and 2918.8 person-years. For the comparative analysis set (IPTW weighted), 0.3 and 42.1 events occurred with a total of 10.1 and 2905.0 person-years. For the comparative matched analysis set, 1 and 1 event occurred with a total of 26.2 and 52.5 person-years. | From index date up to 60 days after last dose |
| Incidence Rate of Malignancy | This study analyzed malignancy by extending follow-up time until the first incident event, death, end of the study period, or loss to follow-up. The primary analysis utilized an ever-exposed approach whereby a person always was considered exposed to the initial treatment. All malignancies were reported in the primary analysis even those that occur after the day of initial treatment. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 7 and 77 events occurred with a total of 172.5 and 4480.2 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 1 and 77 events occurred with a total of 27.7 and 4480.2 person-years. For the comparative analysis set (IPTW weighted), 0.0 and 76.7 events occurred with a total of 10.5 and 4458.5 person-years. For the comparative matched analysis set, 1 and 4 events occurred with a total of 27.7 and 78.4 person-years. | From index date up to the first incident event, death, end of the study period, or loss to follow-up |
Patients treated with Remicade who meet the inclusion/exclusion criteria.
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| Full Analysis Set | Patients who were diagnosed with rheumatoid arthritis, ulcerative colitis, or Crohn's disease; received Infliximab-Pfizer Biosimilar or Remicade; were aged 15 years or older at the index date; and had at least 90 days of look-back period. Patients with pre-existing safety outcome event during the 90-day look-back period were excluded from the study cohort of the respective outcome event. |
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| Comparative Analysis Set | Patients who received Infliximab-Pfizer Biosimilar and Remicade. The comparative analysis set was a subset of the full analysis set who were new users. That is, patients switching from non-Pfizer Infliximab Biosimilar or Remicade to Infliximab-Pfizer Biosimilar were excluded. Also, patients switching from any Infliximab Biosimilar to Remicade were excluded. |
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| COMPLETED |
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| NOT COMPLETED |
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Of the patients who were main cohort in the study, those who met the eligibility criteria were included in the following analysis sets: Full analysis set (Infliximab-Pfizer Biosimilar), n=92; Full analysis set (Remicade), n=2115; Comparative analysis set (Infliximab-Pfizer Biosimilar), n=28; and Comparative analysis set (Remicade), n=2115.
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| ID | Title | Description |
|---|---|---|
| BG000 | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] (Full Analysis Set) | Patients treated with Infliximab-Pfizer Biosimilar who meet the inclusion/exclusion criteria. |
| BG001 | Remicade (Infliximab [Genetical Recombination]) (Full Analysis Set) | Patients treated with Remicade who meet the inclusion/exclusion criteria. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users. | Number | Participants |
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| Sex: Female, Male | The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| 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 | Incidence Rate of Serious Infections | The observation of serious infections was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 9 and 232 events occurred with a total of 151.9 and 2609.9 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 5 and 232 events occurred with a total of 22.8 and 2609.9 person-years. For the comparative analysis set (IPTW weighted), 0.5 and 230.7 events occurred with a total of 3.6 and 2598.5 person-years. For the comparative matched analysis set, 5 and 6 events occurred with a total of 22.8 and 46.7 person-years. | For the analysis of each outcome event, those patients experiencing the same outcome event during the 90-day look-back period prior to the index date were excluded. For serious infections, this resulted in Full analysis set (Infliximab-Pfizer Biosimilar, n=86; Remicade, n=1909), Comparative analysis set (Infliximab-Pfizer Biosimilar, n=23; Remicade, n=1909). | Posted | Number | serious infections per 1 person-year | From index date up to 60 days after last dose |
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| Secondary | Incidence Rate of Tuberculosis | The observation of tuberculosis was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 0 and 14 events occurred with a total of 161.8 and 2904.1 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 0 and 14 events occurred with a total of 27.2 and 2904.1 person-years. For the comparative analysis set (IPTW weighted), 0.0 and 14.3 events occurred with a total of 10.4 and 2889.7 person-years. For the comparative matched analysis set, 0 and 1 event occurred with a total of 27.2 and 50.1 person-years. | For the analysis of each outcome event, those patients experiencing the same outcome event during the 90-day look-back period prior to the index date were excluded. For tuberculosis, this resulted in Full analysis set (Infliximab-Pfizer Biosimilar, n=91; Remicade, n=2100), Comparative analysis set (Infliximab-Pfizer Biosimilar, n=28; Remicade, n=2100). | Posted | Number | tuberculosis per 1 person-year | From index date up to 60 days after last dose |
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| Secondary | Incidence Rate of Serious Blood Disorder | The observation of serious blood disorder was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 1 and 15 events occurred with a total of 163.5 and 2913.5 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 1 and 15 events occurred with a total of 27.5 and 2913.5 person-years. For the comparative analysis set (IPTW weighted), 0.1 and 14.9 events occurred with a total of 10.4 and 2899.6 person-years. For the comparative matched analysis set, 1 and 0 events occurred with a total of 27.5 and 52.5 person-years. | For the analysis of each outcome event, those patients experiencing the same outcome event during the 90-day look-back period prior to the index date were excluded. For serious blood disorder, this resulted in Full analysis set (Infliximab-Pfizer Biosimilar, n=92; Remicade, n=2093), Comparative analysis set (Infliximab-Pfizer Biosimilar, n=28; Remicade, n=2093). | Posted | Number | serious blood disorder per 1 person-year | From index date up to 60 days after last dose |
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| Secondary | Incidence Rate of Interstitial Pneumonia | The observation of interstitial pneumonia was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 5 and 42 events occurred with a total of 157.1 and 2918.8 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 1 and 42 events occurred with a total of 26.2 and 2918.8 person-years. For the comparative analysis set (IPTW weighted), 0.3 and 42.1 events occurred with a total of 10.1 and 2905.0 person-years. For the comparative matched analysis set, 1 and 1 event occurred with a total of 26.2 and 52.5 person-years. | For the analysis of each outcome event, those patients experiencing the same outcome event during the 90-day look-back period prior to the index date were excluded. For interstitial pneumonia, this resulted in Full analysis set (Infliximab-Pfizer Biosimilar, n=91; Remicade, n=2092), Comparative analysis set (Infliximab-Pfizer Biosimilar, n=27; Remicade, n=2092). | Posted | Number | interstitial pneumonia per 1 person-year | From index date up to 60 days after last dose |
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| Secondary | Incidence Rate of Malignancy | This study analyzed malignancy by extending follow-up time until the first incident event, death, end of the study period, or loss to follow-up. The primary analysis utilized an ever-exposed approach whereby a person always was considered exposed to the initial treatment. All malignancies were reported in the primary analysis even those that occur after the day of initial treatment. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 7 and 77 events occurred with a total of 172.5 and 4480.2 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 1 and 77 events occurred with a total of 27.7 and 4480.2 person-years. For the comparative analysis set (IPTW weighted), 0.0 and 76.7 events occurred with a total of 10.5 and 4458.5 person-years. For the comparative matched analysis set, 1 and 4 events occurred with a total of 27.7 and 78.4 person-years. | For the analysis of each outcome event, those patients experiencing the same outcome event during the 90-day look-back period prior to the index date were excluded. For malignancy, this resulted in Full analysis set (Infliximab-Pfizer Biosimilar, n=89; Remicade, n=2094), Comparative analysis set (Infliximab-Pfizer Biosimilar, n=26; Remicade, n=2094). | Posted | Number | malignancy per 1 person-year | From index date up to the first incident event, death, end of the study period, or loss to follow-up |
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Not applicable as adverse events were not planned to be collected during the study.
Minimum criteria for reporting an adverse event (i.e., identifiable patients, identifiable reporter, a suspect product, and event) could not be met. Hence, adverse events were not collected or reported.
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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 Biosimilar3] | Patients treated with Infliximab-Pfizer Biosimilar who meet the inclusion/exclusion criteria. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Remicade (Infliximab [Genetical Recombination]) | Patients treated with Remicade who meet the inclusion/exclusion criteria. | 0 | 0 | 0 | 0 | 0 | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 12, 2024 | Feb 20, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
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| ≥18 and <65 years (Full analysis set) |
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| ≥65 years (Full analysis set) |
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| <18 years (Comparative analysis set) |
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| ≥18 and <65 years (Comparative analysis set) |
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| ≥65 years (Comparative analysis set) |
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| Comparative analysis set |
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| Incidence rate of serious infections (Comparative analysis set) |
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| Incidence rate of serious infections (Comparative analysis set, IPTW weighted) |
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| Incidence rate of serious infections (Comparative matched analysis set) |
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Comparative analysis set, IPTW weighted |
| Risk Ratio (RR) |
| 1.43 |
| 2-Sided |
| 95 |
| 0.38 |
| 5.34 |
Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade. |
| Other |
Estimation |
| Comparative analysis set, IPTW weighted | Risk Difference (RD) | 0.04 | 2-Sided | 95 | -0.20 | 0.11 | Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade. | Other | Estimation |
| Comparative matched analysis set | Cox Proportional Hazard | 1.63 | 2-Sided | 95 | 0.54 | 4.90 | Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade. | Other | Estimation |
| Comparative matched analysis set | Risk Ratio (RR) | 1.71 | 2-Sided | 95 | 0.55 | 5.26 | Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade. | Other | Estimation |
| Comparative matched analysis set | Risk Difference (RD) | 0.09 | 2-Sided | 95 | -0.10 | 0.39 | Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade. | Other | Estimation |
| Comparative analysis set | Cox Proportional Hazard | 2.44 | 2-Sided | 95 | 1.05 | 5.67 | Crude Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade. | Other | Estimation |
| Comparative analysis set | Risk Ratio (RR) | 2.47 | 2-Sided | 95 | 1.02 | 5.99 | Crude Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade. | Other | Estimation |
| Comparative analysis set | Risk Difference (RD) | 0.13 | 2-Sided | 95 | -0.06 | 0.32 | Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade. | Other | Estimation |
| OG001 |
| Remicade (Infliximab [Genetical Recombination]) |
Patients treated with Remicade who meet the inclusion/exclusion criteria. |
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| OG001 | Remicade (Infliximab [Genetical Recombination]) | Patients treated with Remicade who meet the inclusion/exclusion criteria. |
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| OG001 | Remicade (Infliximab [Genetical Recombination]) | Patients treated with Remicade who meet the inclusion/exclusion criteria. |
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| OG001 | Remicade (Infliximab [Genetical Recombination]) | Patients treated with Remicade who meet the inclusion/exclusion criteria. |
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