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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03193957

Enrollment

Registered

2017-06-21

Start date

2017-05-15

Completion date

2017-09-25

Last updated

2017-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

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

Interventions

DRUGEtanercept

Etanercept PFS and Autoinjector

DEVICEAutoinjector

Autoinjector

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026