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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Etanercept; Device: Autoinjector

• Registration Number: NCT03193957
• Lead Sponsor: Samsung Bioepis Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-15
• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-21
• Status Verified: 2017-07
• Primary Completion: 2017-08-03
• Study Completion: 2017-09-25
• Last Update Submitted: 2017-10-12
• Last Update Posted: 2017-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SB4	Autoinjector	SB4 (etanercept) 50 mg/mL
SB4	Etanercept	SB4 (etanercept) 50 mg/mL

Primary Outcome Measures

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

Trial Locations

Locations (1)

AI Centrum Medyczne; 🇵🇱 Poznań, Poland