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

Prior treatment

• 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

Other illness

• 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

Other

• Pregnant and breastfeeding women

• 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