NCT02167139

A Study Comparing SB5 to Humira® 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, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 544 (actual)
• Sponsor: Samsung Bioepis Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Humira (adalimumab)
DRUG	SB5 (proposed biosimilar to adalimumab)

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-04-01
• Completion: 2015-10-01
• First posted: 2014-06-18
• Last updated: 2017-08-17
• Results posted: 2017-01-19

Locations

2 sites across 2 countries: Lithuania, Poland