A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis
Recruiting now · Phase 3
Conditions studied: Rheumatoid Arthritis (RA)
In brief
A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 \[proposed etanercept biosimilar\] to Enbrel® \[EU-sourced\] in rheumatoid arthritis
Key facts
- Study ID
- NCT06596772
- Run by
- mAbxience Research S.L.
- People needed
- 458
- Starts
- 2024-10-03
- Expected to finish
- 2026-01-01
- Last updated by the study team
- 2025-03-24
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research site 2005 — Plovdiv, Bulgaria (enrolling)
- Research Site 2002 — Rousse, Bulgaria (enrolling)
- Research site 2001 — Sofia, Bulgaria (enrolling)
- Research Site 2003 — Sofia, Bulgaria (enrolling)
- Research Site 2008 — Sofia, Bulgaria (enrolling)
- Research site 2004 — Vidin, Bulgaria (enrolling)
- Research site 2006 — Vratsa, Bulgaria (enrolling)
- Research site 7004 — Batumi, Georgia (enrolling)
- Research site 7010 — Batumi, Georgia (enrolling)
- Research site 7001 — Tbilisi, Georgia (enrolling)
- Research site 7002 — Tbilisi, Georgia (enrolling)
- Research site 7003 — Tbilisi, Georgia (enrolling)
- Research site 7005 — Tbilisi, Georgia (enrolling)
- Research site 7006 — Tbilisi, Georgia (enrolling)
- Research site 7007 — Tbilisi, Georgia (enrolling)
- Research site 7009 — Tbilisi, Georgia (enrolling)
- Research Site 1301 — Chisinau, Moldova (enrolling)
- Research site 1302 — Chisinau, Moldova (enrolling)
- Research Site 1603 — Bialystok, Poland (enrolling)
- Research Site 1614 — Bialystok, Poland (enrolling)
- Research site 1616 — Bialystok, Poland (enrolling)
- Research site 1613 — Bydgoszcz, Poland (enrolling)
- Research site 1623 — Bytom, Poland (enrolling)
- Research Site 1615 — Elblag, Poland (enrolling)
- Research site 2007 — Haskovo, Bulgaria (enrolling)
Full record on ClinicalTrials.gov
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