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.
Study Type
OBSERVATIONAL
Enrollment
428
\<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.
Pfizer Local Country Office
Tokyo, Japan
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.
Time frame: 30 weeks from the day of initial dose
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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.