Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Rheumatoid Arthritis)

Active, not recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Infliximab [infliximab biosimilar 3]

• Registration Number: NCT03885037
• Lead Sponsor: Pfizer

Brief Summary

To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against rheumatoid arthritis under actual status of use.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-04
• Study Start: 2019-03-20
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-02-20
• Study Completion: 2025-02-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Patients with rheumatoid arthritis who started treatment with this drug
• Patients who received this drug for the first time 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 Rheumatoid Arthritis 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
Disease Activity Score Based on 28-joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])	Week 30
Percentage of Participants With Remission (DAS28-4[CRP])	Baseline, Week30

Trial Locations

Locations (1)

Pfizer Local Country Office; 🇯🇵 Tokyo, Japan