Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Infliximab Biosimilar
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 584
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 SB2 compared to Remicade in subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy.

Detailed description:

Arms:
arm 1: SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70 arm 2: Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46 arm 3: SB2 3mg/kg at week 54, 62, 70 arm 4: Remicade 3mg/kg at week 54, 62, 70

Interventions: intervention 1: Remicade (infliximab) intervention 2: SB2 (proposed biosimilar to infliximab)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: