An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis

A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects with Rheumatoid Arthritis.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AI Centrum Medyczne

Poznan, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects are male or female aged 18-55 years at the time of signing the informed consent form.

Exclusion criteria

Have been treated previously with monoclonal antibody agent including any tumour necrosis factor inhibitor except SB4.

Treatment and study plan

etanercept

Drug

Etanercept PFS and Autoinjector

Autoinjector

Device

Autoinjector

Primary outcomes

The change in Injection site pain score at immediately post injection (within 1 minute)

Time frame: at Week 1 and Week 3

The change in injection site pain score at immediately post injection (within 1 minute) using an 11-point visual numeric scale

Sponsors and collaborators

Lead sponsor

Samsung Bioepis Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Jun 21, 2017
Registry last updated: Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed