Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, Adalimumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 544
Healthy volunteers: no

Brief summary:
This is a randomised, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to Humira® in subjects with moderate to severe RA despite MTX therapy.

Detailed description:
Investigational product: SB5 40 mg (0.8 mL of 50 mg/mL) Indication studied: Rheumatoid arthritis

Arms:
arm 1: SB5 40 mg every other week via subcutaneous injection arm 2: Humira 40 mg every other week via subcutaneous injection

Interventions: intervention 1: Humira (adalimumab) intervention 2: SB5 (proposed biosimilar to adalimumab)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: