An Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis

Sponsor
Samsung Bioepis Co., Ltd.
Study ID
NCT02565810
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis.

Key Dates

Start date
Sep 30, 2015
Status verified
Dec 2018
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016

Study Design

Enrollment
49 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: SB5 40mg

Primary Outcome Measure

The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale [ Time Frame: Difference of injection site pain score (Week 6 - Week 2) ]

Related Studies