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

Samsung

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Etanercept; Device: Autoinjector

Study type: Interventional

Funder types: Industry

Identifiers

NCT03193957

SB4-G21-RA

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

SB4

Experimental group

Description:

SB4 (etanercept) 50 mg/mL

Treatment:

Drug: Etanercept

Device: Autoinjector