A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis
NCT ID: NCT06596772
Last Updated: 2025-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
458 participants
INTERVENTIONAL
2024-10-03
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MB04 (proposed etanercept biosimilar)
MB04 50 mg/week via subcutaneous injection
MB04 (proposed biosimilar to etanercept)
MB04 50 mg/week via subcutaneous injection
Enbrel (etanercept)
Enbrel 50 mg/week via subcutaneous injection
Enbrel (etanercept)
Enbrel 50 mg/week via subcutaneous injection
Interventions
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MB04 (proposed biosimilar to etanercept)
MB04 50 mg/week via subcutaneous injection
Enbrel (etanercept)
Enbrel 50 mg/week via subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* Moderately to severe RA despite appropriate MTX at baseline therapy defined as having more than or equal to six swollen joints and more than or equal to six tender joints and either erythrocyte sedimentation rate (ESR, Westergren) ≥ 28 mm/h or serum C-reactive protein \> 5.0 mg/dL and positive rheumatoid factor and/or CCP at screening
* Stable dose MTX between 10 to 25 mg weekly during ≥12 weeks, since ≥8 weeks prior to randomization
* Stable dose of NSAID and /or other analgesics for at least 4 weeks prior to randomization, when used
* Stable dose ≤10 mg prednisone daily or equivalent for ≥4 weeks prior to randomization, when used
* Patients who are otherwise medically stable according to investigator\'s discretion
* Agree to use highly effective contraceptive methods up to 6 months after las dose Exclusion
* Previously treated with any biologic or targeted synthetic DMARD
* Previously treated with any monoclonal antibody for other condition than RA
* Hypersensitivity to any component of study drug and/or prefilled syringe components
* Arthritis with onset prior to age 16 years or current diagnosis of inflammatory joint disease other than RA
* Systemic manifestations of RA other that rheumatoid nodules or secondary Sjogren\'s syndrome
* Active infection or potentially relapsing infections that could have a severe outcome. Latent tuberculosis infection detected during screening should start an approved treatment regimen according to standard of care and rescreened
* Solid or hematologic malignancy within the past 5 years
* Pregnant and breastfeeding women
* Any medical condition in the opinion of the investigator that would be a risk for safety, cooperation in the study or interferes with the interpretation of the study results
18 Years
75 Years
ALL
No
Sponsors
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mAbxience Research S.L.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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MB04-C-01-23
Identifier Type: -
Identifier Source: org_study_id
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