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

Phase 3 Recruiting 458 enrolled mAbxience Research S.L.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 \[proposed etanercept biosimilar\] to Enbrel® \[EU-sourced\] in rheumatoid arthritis

Timeline

Start: 2024-10-03
Primary completion: 2025-10
Completion: 2026-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Etanercept	Protein / enzyme biologic	50 mg	Subcutaneous

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

Summary

Timeline

Drugs

Indications