Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

5. oktober 2026 oppdatert av: 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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

501

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Bulgaria
      • Haskovo, Bulgaria
        • Research site 2007
      • Plovdiv, Bulgaria
        • Research site 2005
      • Rousse, Bulgaria
        • Research Site 2002
      • Sofia, Bulgaria
        • Research site 2001
      • Sofia, Bulgaria
        • Research Site 2003
      • Sofia, Bulgaria
        • Research Site 2008
      • Vidin, Bulgaria
        • Research site 2004
      • Vratsa, Bulgaria
        • Research site 2006
  • Georgia
      • Batumi, Georgia
        • Research site 7004
      • Batumi, Georgia
        • Research site 7010
      • Tbilisi, 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
  • 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
  • Romania
      • Bacau, Romania
        • Research Site 1803
      • Brasov, Romania
        • Research Site 1805
      • Bucharest, Romania
        • Research Site 1801
      • Bucharest, Romania
        • Research site 1802
      • Bucharest, Romania
        • Research site 1804
      • Râmnicu Vâlcea, Romania
        • Research site 1806
  • Serbia
      • Belgrade, Serbia
        • Research site 1903
      • Belgrade, Serbia
        • Research site 1904
      • Belgrade, Serbia
        • Research site 1905
      • Novi Sad, Serbia
        • Research Site 1902
      • Zrenjanin, Serbia
        • Research site 1901

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: MB04 (proposed etanercept biosimilar)

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

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

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

Enbrel 50 mg/week via subcutaneous injection

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

mAbxience Research S.L.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. oktober 2024

Primær fullføring (Faktiske)

20. februar 2026

Studiet fullført (Faktiske)

20. februar 2026

Datoer for studieregistrering

Først innsendt

11. september 2024

Først innsendt som oppfylte QC-kriteriene

16. september 2024

Først lagt ut (Faktiske)

19. september 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MB04-C-01-23

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere