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RECRUITING
NCT06596772
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

MB04 (proposed biosimilar to etanercept)

MB04 50 mg/week via subcutaneous injection

DRUG

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