A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis (RA)
- Interventions
- Drug: MB04 (proposed biosimilar to etanercept)
- Registration Number
- NCT06596772
- Lead Sponsor
- mAbxience Research S.L.
- Brief Summary
A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 \[proposed etanercept biosimilar\] to Enbrel® \[EU-sourced\] in rheumatoid arthritis
- Detailed Description
The study will randomize approximately 458 patients aged between 18 and 75 years with active Rheumatoid Arthritis despite methotrexate therapy.
All patients shall receive methotrexate for ≥12 weeks and on a stable dose (10 to 25 mg/week) for ≥8 weeks prior to randomization, and folic acid (≥5 mg/week) from 4 weeks prior to screening until the end of the treatment period (Week 36).
Screening evaluations will be completed within 28 days prior to randomization. There will be 2 periods in the study: Main Treatment period and Transition period.
During the Main Treatment Period, eligible patients will be randomized, at a 1:1 ratio, to administer a 50 mg weekly dose of MB04 or EU- sourced Enbrel® subcutaneously (SC) using an Interactive Response System (IRT). After completing Week 24 assessment, patients will continue to receive the study treatment up to Week 36. Those patients who were originally assigned to EU-sourced Enbrel® will be randomized, at a 1:1 ratio, to receive either MB04 or EU-sourced Enbrel® SC, while patients originally assigned to MB04 will continue with the same treatment until Week 36.
After treatment discontinuation, patients will undergo a Safety follow-up period for 4 weeks, up to week 40.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 458
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MB04 (proposed etanercept biosimilar) MB04 (proposed biosimilar to etanercept) MB04 50 mg/week via subcutaneous injection Enbrel (etanercept) Enbrel (etanercept) Enbrel 50 mg/week via subcutaneous injection
- Primary Outcome Measures
Name Time Method American College of Rheumatology 20% Response Criteria (ACR20) Week 24
- Secondary Outcome Measures
Name Time Method ACR20 Weeks 36 American College of Rheumatology 50% Response Criteria (ACR50) Weeks 24 and 36 American College of Rheumatology 70% Response Criteria (ACR70) Weeks 24 and 36
Trial Locations
- Locations (60)
Research site 2007
🇧🇬Haskovo, Bulgaria
Research site 2005
🇧🇬Plovdiv, Bulgaria
Research Site 2002
🇧🇬Ruse, 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 1804
🇷🇴Bucuresti, 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
Research Site 1607
🇵🇱Warszawa, Poland
Research Site 1609
🇵🇱Warszawa, Poland
Research Site 1625
🇵🇱Wroclaw, Poland
Research Site 1626
🇵🇱Zamość, Poland
Research Site 1803
🇷🇴Bacau, Romania
Research Site 1805
🇷🇴Brasov, Romania
Resarch Site 1801
🇷🇴Bucuresti, Romania
Research site 1802
🇷🇴Bucuresti, Romania
Research Site 1604
🇵🇱Warszawa, Poland
Research Site 1301
🇲🇩Chișinău, Moldova, Republic of
Research site 1302
🇲🇩Chișinău, Moldova, Republic of
Research Site 1614
🇵🇱Bialystok, Poland
Research Site 1603
🇵🇱Białystok, Poland
Research site 1616
🇵🇱Białystok, 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
🇵🇱Piotrków 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