Clinical Trial

A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis

Recruiting Phase 3
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Record status
This record was last updated March 24, 2025 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.
Summary
A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 \[proposed etanercept biosimilar\] to Enbrel® \[EU-sourced\] in rheumatoid arthritis
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-09-16; most recent amendment 2025-03-21.
Trial Details
NCT Number NCT06596772
Lead Sponsor mAbxience Research S.L.
Conditions Rheumatoid Arthritis (RA)
Enrollment 458 participants
Start Date 2024-10-03
Primary Completion 2025-10 (estimated)
Study Completion 2026-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-24