NCT01895309

A Study Comparing SB4 to Enbrel® 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 SB4 Compared to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 596 (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 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Enbrel (etanercept)
DRUG	SB4 (proposed biosimilar to etanercept)

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-04-01
• Completion: 2015-10-01
• First posted: 2013-07-10
• Last updated: 2017-08-17
• Results posted: 2016-08-29

Locations

2 sites across 2 countries: Poland, United Kingdom