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

StatusCompleted
PhasePhase 3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria revised
    • Study sites revised (60)
  2. Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of Oct 2025 to Feb 20, 2026
    • Enrollment target: estimated 458 to confirmed 501
    • Eligibility criteria expanded, about 16 words
    • Site details revised at 60 of 60 sites
  3. Site details revised at 2 of 60 sitesv5
  4. Site details revised at 7 of 60 sitesv4
  5. Study sites: 34 to 60v3
  6. Study sites: 2 to 34
    • Start date changed from estimate of Sep 11, 2024 to Oct 3, 2024
    v2
  7. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 \[proposed etanercept biosimilar\] to Enbrel® \[EU-sourced\] in rheumatoid arthritis
Trial Details
NCT Number NCT06596772
Lead Sponsor mAbxience Research S.L.
Conditions
(from sponsor)		 Rheumatoid Arthritis (RA)
Related terms Arthritis, Rheumatoid
Enrollment 501 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov