A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 [proposed etanercept biosimilar] to Enbrel® [EU-sourced] in rheumatoid arthritis
Key facts
- Where
- Budapest, Budapest II, Budapest III, Hódmezővásárhely, Kalocsa, Székesfehérvár, Szolnok és Veszprem, MagyarországSee the 8 sites
- Phase
- 3. fázis
Where in Magyarország
- Qualiclinic Kft.Budapest, MagyarországNo longer taking part
- Revita Kft.Budapest II, MagyarországNo longer taking part
- Obudai Egeszseguegyi Centrum Kft.Budapest III, MagyarországNo longer taking part
- Vasarhelyi Sarkanyfu Kft.Hódmezővásárhely, MagyarországNo longer taking part
- Je-Med Bt.Kalocsa, MagyarországNo longer taking part
- Complex Rendelo Med Zrt.Székesfehérvár, MagyarországNo longer taking part
- MÁV Kórház és Rendelointézet SzolnokSzolnok, MagyarországNo longer taking part
- Vital-Medicina Kft.Veszprem, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mabxience Research S.L.
- Trial code
- EU 2024-510826-16-00
- Record updated
- 2025. december 17.
- Original description
To compare the efficacy of MB04 with European Union (EU)-sourced Enbrel® at Week 24 in terms of American College of Rheumatology 20% response criteria (ACR20) in patients with moderate to severe rheumatoid arthritis (RA) on methotrexate (MTX) therapyRead full original descriptionShow less
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.
To compare the efficacy of MB04 with European Union (EU)-sourced Enbrel® at Week 24 in terms of American College of Rheumatology 20% response criteria (ACR20) in patients with moderate to severe rheumatoid arthritis (RA) on methotrexate (MTX) therapy
Inclusion: Adult (male or female) between 18 to 75 years; Rheumatoid Arthritis (RA) diagnosis ≥6 months prior to randomization (time from diagnosis <15 years); Moderately to severe RA despite appropriate MTX at baseline therapy; 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 other condition than RA; Arthritis with onset prior to age 16 years or current diagnosis of inflammatory joint disease other than RA; Hypersensitivity to any component of study drug and/or prefilled syringe components; 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; 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; Pregnant and breastfeeding women.