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

A regiszterben nem jelölt feltételek

• 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