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To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against Crohn's disease or ulcerative colitis under actual status of use.
This study will be conducted with all-case investigation system in patients with Crohn's disease or ulcerative colitis.
This study will be conducted in patients who used this drug after the day of approval of dosage and administration for Crohn's disease or ulcerative colitis 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 Crohn's Disease or Ulcerative Colitis treated by Infliximab BS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab [infliximab biosimilar 3] | Drug | <Crohn's disease> The usual dose is 5 mg as Infliximab [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 reduced effects. At an increased dose, the dose may be adjusted to 10 mg for every kg of body weight. At a reduced dosing interval, the dose of 5 mg for every kg of body weight may be given at the minimum dosing interval of 4 weeks. <Ulcerative colitis> The usual dose is 5 mg as Infliximab [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. |
| 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. 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 Remission (Crohn's Disease Activity Index [CDAI]) for Crohn's Disease | Percentage of participants with remission of Crohn's disease was presented using the Crohn's Disease Activity Index score along with the two-sided 95% confidence interval (exact method). The Crohn's Disease Activity Index score is calculated from the following 8 items: (1) the number of watery or mushy stools, (2) abdominal pain (0 to 3), (3) general condition (0 to 4), (4) symptoms and signs considered to be related to Crohn's disease (0 to6), (5) use of Lomotil/Opiate for diarrhea (0 to 1), (6) abdominal mass (0 to 5), (7) hematocrit(%), and (8) score derived from body weight, that is the sum of 2x(1)+5x(2)+7x(3)+20x(4)+30x(5)+10x(6)+6x(7)+(8). A Crohn's Disease Activity IndexI score of <150 was considered remission. |
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Inclusion Criteria:
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Patients with Crohn's Disease or Ulcerative Colitis 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 Crohn's disease or Ulcerative colitis 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 416 participants started the study. Of the 416 participants, 371 completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] | Participants with Crohn's disease or Ulcerative colitis 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. Relatedness to Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] was assessed by the physician. | The safety analysis set (371 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 and contract violation/deficiency 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 serious and non-serious 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 Crohn's disease or Ulcerative colitis 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA/J26.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac 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 | Jan 17, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2023 | Jan 17, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
|
| Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period. |
| Percentage of Participants With Improvement the Crohn's Disease Activity Index for Crohn's Disease | Percentage of participants with improvement of Crohn's disease was presented using the Crohn's Disease Activity Index score along with the two-sided 95% confidence interval (exact method). The Crohn's Disease Activity Index score is calculated from the following 8 items:(1) the number of watery or mushy stools, (2) abdominal pain (0 to 3), (3) general condition (0 to 4), (4) symptoms and signs considered to be related to Crohn's disease (0 to6), (5) use of Lomotil/Opiate for diarrhea (0 to 1), (6) abdominal mass (0 to 5), (7) hematocrit(%), and (8) score derived from body weight, that is the sum of 2x(1)+5x(2)+7x(3)+20x(4)+30x(5)+10x(6)+6x(7)+(8). The Crohn's Disease Activity Index improvement was defined as a decrease of 25% or more and 70 points or more in Crohn's Disease Activity Index score after treatment with Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] compared with the Crohn's Disease Activity Index score before treatment. | Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period. |
| Percentage of Participants With Remission (Partial Mayo) Score for Ulcerative Colitis | Percentage of participants with remission of Ulcerative colitis was presented using the partial Mayo score along with the two-sided 95% confidence interval (exact method). The partial Mayo score is the sum of the subscores for the following 3 domains with a range of 0 to 9 points; the number of bowel movements subscore (0 to 3), rectal bleeding subscore (0 to 3), and physician's global assessment subscore (0 to 3). Partial Mayo score of <2 was considered partial Mayo score remission. | Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period. |
| Percentage of Participants With Improvement (Partial Mayo) Score for Ulcerative Colitis | Percentage of participants with improvement of Ulcerative colitis was presented using the partial Mayo score along with the two-sided 95% confidence interval (exact method). The partial Mayo score is the sum of the subscores for the following 3 domains with a range of 0 to 9 points; the number of bowel movements subscore (0 to 3), rectal bleeding subscore (0 to 3), and physician's global assessment subscore (0 to 3). Partial Mayo score improvement was defined as 2 points or more reduction from baseline. | Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period. |
| Change of Mayo Score From Baseline to Study Completion Date for Ulcerative Colitis | Summary statistics of the Mayo score at baseline, at study completion date, and the change in Mayo score from baseline to study completion date in participants with Ulcerative colitis. The Mayo score consists of 4 domains, each scored as a 0- to 3-point subscore, with higher scores indicating more severe disease activity. The 4 domains are the number of bowel movements subscore (0 to 3), rectal bleeding subscore (0 to 3), endoscopic finding subscore (0 to 3), and physician's global assessment subscore (0 to 3). The method of calculating the Mayo score is the sum of all subscores in the 4 domains, with a range of 0 to 12 points. | Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period. |
| 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 |
|
Participants with Crohn's disease or Ulcerative colitis 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 Remission (Crohn's Disease Activity Index [CDAI]) for Crohn's Disease | Percentage of participants with remission of Crohn's disease was presented using the Crohn's Disease Activity Index score along with the two-sided 95% confidence interval (exact method). The Crohn's Disease Activity Index score is calculated from the following 8 items: (1) the number of watery or mushy stools, (2) abdominal pain (0 to 3), (3) general condition (0 to 4), (4) symptoms and signs considered to be related to Crohn's disease (0 to6), (5) use of Lomotil/Opiate for diarrhea (0 to 1), (6) abdominal mass (0 to 5), (7) hematocrit(%), and (8) score derived from body weight, that is the sum of 2x(1)+5x(2)+7x(3)+20x(4)+30x(5)+10x(6)+6x(7)+(8). A Crohn's Disease Activity IndexI score of <150 was considered remission. | The efficacy analysis set (348 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 348 participants, percentage of remission and improvement of Crohn's disease as of the end date of the study was calculated for the 151 participants whose effectiveness was evaluated by the CDAI score. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period. |
|
|
|
| Secondary | Percentage of Participants With Improvement the Crohn's Disease Activity Index for Crohn's Disease | Percentage of participants with improvement of Crohn's disease was presented using the Crohn's Disease Activity Index score along with the two-sided 95% confidence interval (exact method). The Crohn's Disease Activity Index score is calculated from the following 8 items:(1) the number of watery or mushy stools, (2) abdominal pain (0 to 3), (3) general condition (0 to 4), (4) symptoms and signs considered to be related to Crohn's disease (0 to6), (5) use of Lomotil/Opiate for diarrhea (0 to 1), (6) abdominal mass (0 to 5), (7) hematocrit(%), and (8) score derived from body weight, that is the sum of 2x(1)+5x(2)+7x(3)+20x(4)+30x(5)+10x(6)+6x(7)+(8). The Crohn's Disease Activity Index improvement was defined as a decrease of 25% or more and 70 points or more in Crohn's Disease Activity Index score after treatment with Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] compared with the Crohn's Disease Activity Index score before treatment. | The efficacy analysis set (348 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 348 participants, percentage of remission and improvement of Crohn's disease as of the end date of the study was calculated for the 151 participants whose effectiveness was evaluated by the CDAI score. | Posted | Number | 95% Confidence Interval | Percentage of participants | Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period. |
|
|
|
| Secondary | Percentage of Participants With Remission (Partial Mayo) Score for Ulcerative Colitis | Percentage of participants with remission of Ulcerative colitis was presented using the partial Mayo score along with the two-sided 95% confidence interval (exact method). The partial Mayo score is the sum of the subscores for the following 3 domains with a range of 0 to 9 points; the number of bowel movements subscore (0 to 3), rectal bleeding subscore (0 to 3), and physician's global assessment subscore (0 to 3). Partial Mayo score of <2 was considered partial Mayo score remission. | The efficacy analysis set (348 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 348 participants, percentage of remission and improvement of Ulcerative colitis as of the end date of the study was calculated for the 87 participants whose effectiveness was evaluated by the partial Mayo score. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period. |
|
|
|
| Secondary | Percentage of Participants With Improvement (Partial Mayo) Score for Ulcerative Colitis | Percentage of participants with improvement of Ulcerative colitis was presented using the partial Mayo score along with the two-sided 95% confidence interval (exact method). The partial Mayo score is the sum of the subscores for the following 3 domains with a range of 0 to 9 points; the number of bowel movements subscore (0 to 3), rectal bleeding subscore (0 to 3), and physician's global assessment subscore (0 to 3). Partial Mayo score improvement was defined as 2 points or more reduction from baseline. | The efficacy analysis set (348 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 348 participants, percentage of remission and improvement of Ulcerative colitis as of the end date of the study was calculated for the 87 participants whose effectiveness was evaluated by the partial Mayo score. | Posted | Number | 95% Confidence Interval | Percentage of participants | Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period. |
|
|
|
| Secondary | Change of Mayo Score From Baseline to Study Completion Date for Ulcerative Colitis | Summary statistics of the Mayo score at baseline, at study completion date, and the change in Mayo score from baseline to study completion date in participants with Ulcerative colitis. The Mayo score consists of 4 domains, each scored as a 0- to 3-point subscore, with higher scores indicating more severe disease activity. The 4 domains are the number of bowel movements subscore (0 to 3), rectal bleeding subscore (0 to 3), endoscopic finding subscore (0 to 3), and physician's global assessment subscore (0 to 3). The method of calculating the Mayo score is the sum of all subscores in the 4 domains, with a range of 0 to 12 points. | The efficacy analysis set (348 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 348 participants, summary statistics and change of the Mayo score was calculated for the 15 participants with Ulcerative colitis whose effectiveness was evaluated by the Mayo score. | Posted | Mean | Standard Deviation | Points on a scale | Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period. |
|
|
|
| 0 |
| 371 |
| 3 |
| 371 |
| 12 |
| 371 |
| Appendicitis | Infections and infestations | MedDRA/J26.1 | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J26.1 | Non-systematic Assessment |
|
| Auricular swelling | Ear and labyrinth disorders | MedDRA/J26.1 | Non-systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA/J26.1 | Non-systematic Assessment |
|
| Intestinal stenosis | Gastrointestinal disorders | MedDRA/J26.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA/J26.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA/J26.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA/J26.1 | Non-systematic Assessment |
|
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA/J26.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA/J26.1 | Non-systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA/J26.1 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA/J26.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA/J26.1 | Non-systematic Assessment |
|
| Urticaria | 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.
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|