Infliximab Biosimilar Pfizer Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis)

Conditions
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Crohn's Disease, Ulcerative Colitis

Intervention / Treatment
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* Drug: Infliximab [infliximab biosimilar 3]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Crohn's disease or ulcerative colitis who started treatment with this drug Patients who received this drug for the first time at the medical institution after the day of launch of this drug.

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infliximab [infliximab biosimilar 3]<br>Patients with Crohn's Disease or Ulcerative Colitis treated by Infliximab BS | Drug: Infliximab [infliximab biosimilar 3]<br>* <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.<br>* Other names: Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions |  | 30 weeks from the day of initial dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Remission (Clinical Disease Activity Index (CDAI)) for Crohn's disease |  | Week 30 | 
| Percentage of Participants With Improvement (Clinical Disease Activity Index (CDAI)) for Crohn's disease |  | Week 30 | 
| Percentage of Participants With Remission (Mayo) score for ulcerative colitis |  | Week 30 | 
| Percentage of Participants With Improvement (Mayo) score for ulcerative colitis |  | Week 30 | 
| Partial mayo Score |  | Baseline, Week 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease, Ulcerative Colitis, Infliximab, biosimilar