Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Etanercept Biosimilar
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 596
Healthy volunteers: no

Brief summary:
This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB4 compared to Enbrel in subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy. In some countries, after 52 weeks of treatment with either SB4 or Enbrel, subjects will be enrolled into an open label extension period. Subjects will receive SB4 for an additional 48 weeks.

Detailed description:

Arms:
arm 1: SB4 50 mg/week via subcutaneous injection arm 2: Enbrel 50 mg/week via subcutaneous injection

Interventions: intervention 1: Enbrel (etanercept) intervention 2: SB4 (proposed biosimilar to etanercept)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: