NCT01936181

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 584 (actual)
• Sponsor: Samsung Bioepis Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Remicade (infliximab)
DRUG	SB2 (proposed biosimilar to infliximab)

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-09-01
• Completion: 2015-09-01
• First posted: 2013-09-05
• Last updated: 2017-09-14
• Results posted: 2016-08-29

Locations

2 sites across 2 countries: Bulgaria, Lithuania