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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03884439
• Other study ID #: B5371008
• Status: Completed
• Start date: March 18, 2019
• Est. completion date: February 2, 2024

Study information

• Verified date: February 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: February 2, 2024
• Est. primary completion date: February 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Infliximab [infliximab biosimilar 3]
<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.

Locations

Country	Name	City	State
Japan	Pfizer Local Country Office	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse drug reactions		30 weeks from the day of initial dose
Secondary	Percentage of Participants With Remission (Clinical Disease Activity Index (CDAI)) for Crohn's disease		Week 30
Secondary	Percentage of Participants With Improvement (Clinical Disease Activity Index (CDAI)) for Crohn's disease		Week 30
Secondary	Percentage of Participants With Remission (Partial Mayo) score for ulcerative colitis		Week 30
Secondary	Percentage of Participants With Improvement (Partial Mayo) score for ulcerative colitis		Week 30
Secondary	Mayo Score		Baseline, Week 30

External Links

•   To obtain contact information for a study center near you, click here.