A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 \[proposed etanercept biosimilar\] to Enbrel® \[EU-sourced\] in rheumatoid arthritis
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
None
Parallel
MB04 (proposed biosimilar to etanercept)
DrugMB04 50 mg/week via subcutaneous injection
Enbrel (etanercept)
DrugEnbrel 50 mg/week via subcutaneous injection
American College of Rheumatology 20% Response Criteria (ACR20)
ACR20
American College of Rheumatology 50% Response Criteria (ACR50)
American College of Rheumatology 70% Response Criteria (ACR70)
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