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

Completed

• Conditions: Ulcerative Colitis; Crohn's Disease
• Interventions: Drug: Infliximab [infliximab biosimilar 3]

• Registration Number: NCT03884439
• Lead Sponsor: Pfizer

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-03-04
• Study Start: 2019-03-18
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Status Verified: 2024-02
• Primary Completion: 2024-02-02
• Study Completion: 2024-02-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 428

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infliximab [infliximab biosimilar 3]	Infliximab [infliximab biosimilar 3]	Patients with Crohn's Disease or Ulcerative Colitis treated by Infliximab BS

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions	30 weeks from the day of initial dose

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Improvement (Clinical Disease Activity Index (CDAI)) for Crohn's disease	Week 30
Percentage of Participants With Remission (Partial Mayo) score for ulcerative colitis	Week 30
Percentage of Participants With Improvement (Partial Mayo) score for ulcerative colitis	Week 30
Mayo Score	Baseline, Week 30
Percentage of Participants With Remission (Clinical Disease Activity Index (CDAI)) for Crohn's disease	Week 30

Trial Locations

Locations (1)

Pfizer Local Country Office; 🇯🇵 Tokyo, Japan