A Study Comparing SB2 to Remicade� in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

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.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, 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 Despite Methotrexate Therapy
Estimated Enrollment: 584
Study Start Date: August 2013
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Arms:
- Experimental: SB2 (proposed biosimilar to inflixmab)
- Active Comparator: Remicade (infliximab)
- Experimental: Remicade (infliximab), switch to SB2
- Active Comparator: Remicade (infliximab), continue as Remicade