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A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis
Sponsor: mAbxience Research S.L.
Summary
A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 \[proposed etanercept biosimilar\] to Enbrel® \[EU-sourced\] in rheumatoid arthritis
Official title: A Prospective, Randomized, Double-blind, Parallel-group Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of MB04 and EU-sourced Enbrel® in Patients with Moderate to Severe Rheumatoid Arthritis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
458
Start Date
2024-10-03
Completion Date
2026-01
Last Updated
2025-03-24
Healthy Volunteers
No
Conditions
Interventions
MB04 (proposed biosimilar to etanercept)
MB04 50 mg/week via subcutaneous injection
Enbrel (etanercept)
Enbrel 50 mg/week via subcutaneous injection
Locations (60)
Research site 2007
Haskovo, Bulgaria
Research site 2005
Plovdiv, Bulgaria
Research Site 2002
Rousse, Bulgaria
Research site 2001
Sofia, Bulgaria
Research Site 2003
Sofia, Bulgaria
Research Site 2008
Sofia, Bulgaria
Research site 2004
Vidin, Bulgaria
Research site 2006
Vratsa, Bulgaria
Research site 7004
Batumi, Georgia
Research site 7010
Batumi, Georgia
Research site 7001
Tbilisi, Georgia
Research site 7002
Tbilisi, Georgia
Research site 7003
Tbilisi, Georgia
Research site 7005
Tbilisi, Georgia
Research site 7006
Tbilisi, Georgia
Research site 7007
Tbilisi, Georgia
Research site 7009
Tbilisi, Georgia
Research Site 1301
Chisinau, Moldova
Research site 1302
Chisinau, Moldova
Research Site 1603
Bialystok, Poland
Research Site 1614
Bialystok, Poland
Research site 1616
Bialystok, Poland
Research site 1613
Bydgoszcz, Poland
Research site 1623
Bytom, Poland
Research Site 1615
Elblag, Poland
Research Site 1627
Elblag, Poland
Research Site 1606
Gdynia, Poland
Research Site 1611
Katowice, Poland
Research Site 1617
Krakow, Poland
Research Site 1622
Lublin, Poland
Research site 1605
Nowa Sól, Poland
Research Site 1618
Opole, Poland
Research site 1628
Piotrkow Trybunalski, Poland
Research Site 1624
Poniatowa, Poland
Resarch Site 1619
Poznan, Poland
Research Site 1601
Poznan, Poland
Research Site 1602
Poznan, Poland
Research Site 1608
Poznan, Poland
Research Site 1621
Poznan, Poland
Research Site 1612
Siedlce, Poland
Research Site 1610
Sochaczew, Poland
Research site 1629
Stalowa Wola, Poland
Research Site 1620
Torun, Poland
Research Site 1604
Warsaw, Poland
Research Site 1607
Warsaw, Poland
Research Site 1609
Warsaw, Poland
Research Site 1625
Wroclaw, Poland
Research Site 1626
Zamość, Poland
Research Site 1803
Bacau, Romania
Research Site 1805
Brasov, Romania
Resarch Site 1801
Bucharest, Romania
Research site 1802
Bucharest, Romania
Research site 1804
Bucharest, Romania
Research site 1303
Chisináu, Romania
Research site 1806
Râmnicu Vâlcea, Romania
Research site 1903
Belgrade, Serbia
Research site 1904
Belgrade, Serbia
Research site 1905
Belgrade, Serbia
Research Site 1902
Novi Sad, Serbia
Research site 1901
Zrenjanin, Serbia