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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
Led by mAbxience Research S.L. · Updated on 2025-03-24
458
Participants Needed
60
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 \[proposed etanercept biosimilar\] to Enbrel® \[EU-sourced\] in rheumatoid arthritis
CONDITIONS
Official Title
A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of rheumatoid arthritis consistent with 2010 ACR/EULAR criteria at least 6 months before randomization but not over 15 years before screening
- Moderate to severe rheumatoid arthritis despite methotrexate therapy, defined by at least six swollen and six tender joints plus elevated ESR or CRP and positive rheumatoid factor and/or CCP at screening
- Stable methotrexate dose of 10 to 25 mg weekly for at least 8 weeks prior to randomization
- Stable dose of NSAIDs and/or other analgesics for at least 4 weeks before randomization, if used
- Stable dose of prednisone (up to 10 mg daily) or equivalent for at least 4 weeks before randomization, if used
- Medically stable as judged by the investigator
- Agree to use effective contraception up to 6 months after the last dose
You will not qualify if you...
- Previous treatment with any biologic or targeted synthetic DMARD
- Previous treatment with any monoclonal antibody for conditions other than rheumatoid arthritis
- Hypersensitivity to any component of the study drug or prefilled syringe
- Arthritis beginning before age 16 or diagnosis of inflammatory joint disease other than rheumatoid arthritis
- Systemic rheumatoid arthritis manifestations other than rheumatoid nodules or secondary Sjogren's syndrome
- Active or potentially relapsing severe infections; latent tuberculosis must be treated and rescreened
- Solid or blood cancer within the past 5 years
- Pregnant or breastfeeding women
- Any medical condition that might risk safety, cooperation, or interfere with study results as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 60 locations
1
Research site 2007
Haskovo, Bulgaria
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2
Research site 2005
Plovdiv, Bulgaria
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3
Research Site 2002
Rousse, Bulgaria
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4
Research site 2001
Sofia, Bulgaria
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5
Research Site 2003
Sofia, Bulgaria
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6
Research Site 2008
Sofia, Bulgaria
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7
Research site 2004
Vidin, Bulgaria
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8
Research site 2006
Vratsa, Bulgaria
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9
Research site 7004
Batumi, Georgia
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10
Research site 7010
Batumi, Georgia
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11
Research site 7001
Tbilisi, Georgia
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12
Research site 7002
Tbilisi, Georgia
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13
Research site 7003
Tbilisi, Georgia
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14
Research site 7005
Tbilisi, Georgia
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15
Research site 7006
Tbilisi, Georgia
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16
Research site 7007
Tbilisi, Georgia
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17
Research site 7009
Tbilisi, Georgia
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18
Research Site 1301
Chisinau, Moldova, MD-2068
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19
Research site 1302
Chisinau, Moldova, MD2025
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20
Research Site 1603
Bialystok, Poland
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21
Research Site 1614
Bialystok, Poland
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22
Research site 1616
Bialystok, Poland
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23
Research site 1613
Bydgoszcz, Poland
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24
Research site 1623
Bytom, Poland
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25
Research Site 1615
Elblag, Poland
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26
Research Site 1627
Elblag, Poland
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27
Research Site 1606
Gdynia, Poland
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28
Research Site 1611
Katowice, Poland
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29
Research Site 1617
Krakow, Poland
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30
Research Site 1622
Lublin, Poland
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31
Research site 1605
Nowa Sól, Poland
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32
Research Site 1618
Opole, Poland
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33
Research site 1628
Piotrkow Trybunalski, Poland
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34
Research Site 1624
Poniatowa, Poland
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35
Resarch Site 1619
Poznan, Poland
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36
Research Site 1601
Poznan, Poland
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37
Research Site 1602
Poznan, Poland
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38
Research Site 1608
Poznan, Poland
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39
Research Site 1621
Poznan, Poland
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40
Research Site 1612
Siedlce, Poland
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41
Research Site 1610
Sochaczew, Poland
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42
Research site 1629
Stalowa Wola, Poland
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43
Research Site 1620
Torun, Poland
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44
Research Site 1604
Warsaw, Poland
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45
Research Site 1607
Warsaw, Poland
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46
Research Site 1609
Warsaw, Poland
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47
Research Site 1625
Wroclaw, Poland
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48
Research Site 1626
Zamość, Poland
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49
Research Site 1803
Bacau, Romania
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50
Research Site 1805
Brasov, Romania
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51
Resarch Site 1801
Bucharest, Romania
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52
Research site 1802
Bucharest, Romania
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53
Research site 1804
Bucharest, Romania
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54
Research site 1303
Chisináu, Romania
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55
Research site 1806
Râmnicu Vâlcea, Romania
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56
Research site 1903
Belgrade, Serbia
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57
Research site 1904
Belgrade, Serbia
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58
Research site 1905
Belgrade, Serbia
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59
Research Site 1902
Novi Sad, Serbia
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60
Research site 1901
Zrenjanin, Serbia
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Research Team
S
Susana Millan, PhD
CONTACT
A
Amalia Flórez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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