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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

5. oktober 2026 opdateret af: mAbxience Research S.L.

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

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

501

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Bulgarien
      • Haskovo, Bulgarien
        • Research site 2007
      • Plovdiv, Bulgarien
        • Research site 2005
      • Rousse, Bulgarien
        • Research Site 2002
      • Sofia, Bulgarien
        • Research site 2001
      • Sofia, Bulgarien
        • Research Site 2003
      • Sofia, Bulgarien
        • Research Site 2008
      • Vidin, Bulgarien
        • Research site 2004
      • Vratsa, Bulgarien
        • Research site 2006
  • Georgien
      • Batumi, Georgien
        • Research site 7004
      • Batumi, Georgien
        • Research site 7010
      • Tbilisi, Georgien
        • Research site 7001
      • Tbilisi, Georgien
        • Research site 7002
      • Tbilisi, Georgien
        • Research site 7003
      • Tbilisi, Georgien
        • Research site 7005
      • Tbilisi, Georgien
        • Research site 7006
      • Tbilisi, Georgien
        • Research site 7007
      • Tbilisi, Georgien
        • Research site 7009
  • Moldova
      • Chisinau, Moldova, MD-2068
        • Research Site 1301
      • Chisinau, Moldova, MD2025
        • Research site 1302
      • Chisinau, Moldova
        • Research site 1303
  • Polen
      • Bialystok, Polen
        • Research Site 1603
      • Bialystok, Polen
        • Research Site 1614
      • Bialystok, Polen
        • Research site 1616
      • Bydgoszcz, Polen
        • Research site 1613
      • Bytom, Polen
        • Research site 1623
      • Elblag, Polen
        • Research Site 1615
      • Elblag, Polen
        • Research Site 1627
      • Gdynia, Polen
        • Research Site 1606
      • Katowice, Polen
        • Research Site 1611
      • Krakow, Polen
        • Research Site 1617
      • Lublin, Polen
        • Research Site 1622
      • Nowa Sól, Polen
        • Research site 1605
      • Opole, Polen
        • Research Site 1618
      • Piotrkow Trybunalski, Polen
        • Research site 1628
      • Poniatowa, Polen
        • Research Site 1624
      • Poznan, Polen
        • Research Site 1601
      • Poznan, Polen
        • Research Site 1602
      • Poznan, Polen
        • Research Site 1608
      • Poznan, Polen
        • Research Site 1619
      • Poznan, Polen
        • Research Site 1621
      • Siedlce, Polen
        • Research Site 1612
      • Sochaczew, Polen
        • Research Site 1610
      • Stalowa Wola, Polen
        • Research site 1629
      • Torun, Polen
        • Research Site 1620
      • Warsaw, Polen
        • Research Site 1604
      • Warsaw, Polen
        • Research Site 1607
      • Warsaw, Polen
        • Research Site 1609
      • Wroclaw, Polen
        • Research Site 1625
      • Zamość, Polen
        • Research Site 1626
  • Rumænien
      • Bacau, Rumænien
        • Research Site 1803
      • Brasov, Rumænien
        • Research Site 1805
      • Bucharest, Rumænien
        • Research Site 1801
      • Bucharest, Rumænien
        • Research site 1802
      • Bucharest, Rumænien
        • Research site 1804
      • Râmnicu Vâlcea, Rumænien
        • Research site 1806
  • Serbien
      • Belgrade, Serbien
        • Research site 1903
      • Belgrade, Serbien
        • Research site 1904
      • Belgrade, Serbien
        • Research site 1905
      • Novi Sad, Serbien
        • Research Site 1902
      • Zrenjanin, Serbien
        • Research site 1901

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion

  • Documented history of RA diagnosis consistent with the 2010 ACR/EULAR classification criteria ≥6 months prior to randomization (but not exceeding 15 years prior to screening).
  • 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 last dose Exclusion
  • Previously treated with any biologic or targeted synthetic DMARD
  • Previously treated with any monoclonal antibody for a condition other 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 than 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: MB04 (proposed etanercept biosimilar)

MB04 50 mg/week via subcutaneous injection
Medicin: MB04 (proposed biosimilar to etanercept)

MB04 50 mg/week via subcutaneous injection
Aktiv komparator: Enbrel (etanercept)

Enbrel 50 mg/week via subcutaneous injection
Medicin: Enbrel (etanercept)

Enbrel 50 mg/week via subcutaneous injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
American College of Rheumatology 20 % responskriterier (ACR20)
Tidsramme: Uge 24
Uge 24

Sekundære resultatmål

Resultatmål
Tidsramme
ACR20
Tidsramme: Uge 36
Uge 36
American College of Rheumatology 50 % responskriterier (ACR50)
Tidsramme: Uge 24 og 36
Uge 24 og 36
American College of Rheumatology 70 % responskriterier (ACR70)
Tidsramme: Uge 24 og 36
Uge 24 og 36

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

mAbxience Research S.L.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. oktober 2024

Primær færdiggørelse (Faktiske)

20. februar 2026

Studieafslutning (Faktiske)

20. februar 2026

Datoer for studieregistrering

Først indsendt

11. september 2024

Først indsendt, der opfyldte QC-kriterier

16. september 2024

Først opslået (Faktiske)

19. september 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MB04-C-01-23

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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