RecruitingPhase 3NCT06596772

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

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

Sponsor

mAbxience Research S.L.

Enrollment

458 participants

Start Date

Oct 3, 2024

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis (RA)

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new biosimilar medication (MB04) to the existing branded drug Enbrel (etanercept) for treating moderate to severe rheumatoid arthritis (RA). Biosimilars are highly similar copies of approved biological drugs. **You may be eligible if...** - You have been diagnosed with rheumatoid arthritis for at least 6 months - Your arthritis is moderately to severely active (at least 6 swollen and 6 tender joints) - You have been on a stable dose of methotrexate (10–25 mg/week) for at least 12 weeks - Your other RA medications have been at stable doses for at least 4 weeks **You may NOT be eligible if...** - You have previously used any biologic or targeted synthetic disease-modifying drug - You have had a solid or blood cancer in the past 5 years - You are pregnant or breastfeeding - You have an active or serious infection - You have arthritis from a cause other than RA - You have a known allergy to the study drug components Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMB04 (proposed biosimilar to etanercept)

MB04 50 mg/week via subcutaneous injection

DRUGEnbrel (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

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NCT06596772

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