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CompletedNCT03193957Updated Oct 13, 2017

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 Phase 2 interventional study of Etanercept and Autoinjector in Rheumatoid Arthritis, sponsored by Samsung Bioepis Co., Ltd.. Completed at 1 site in Poland. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-10-13.

Sponsored by Samsung Bioepis Co., Ltd. · Phase 2, Interventional, and Other

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.

This study's enrollment of 50 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Samsung Bioepis Co., Ltd. is the lead sponsor of 33 studies on the registry; 2 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Have been treated previously with monoclonal antibody agent including any tumour necrosis factor inhibitor except SB4.
05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    SB4

    SB4 (etanercept) 50 mg/mL

    Drug: Etanercept · Device: Autoinjector

Interventions

  • DrugEtanercept

    Etanercept PFS and Autoinjector

  • DeviceAutoinjector

    Autoinjector

06

What researchers measure

Primary outcomes

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

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

    Time frame: at Week 1 and Week 3

07

Study locations

1 site
  • AI Centrum Medyczne
    Poznań, Poland
08

References and documents

Publications

  • Rho YH, Rychlewska-Hanczewska A, Sliwowska B, Kim TH. Usability of Prefilled Syringe and Autoinjector for SB4 (An Etanercept Biosimilar) in Patients with Rheumatoid Arthritis. Adv Ther. 2019 Sep;36(9):2287-2295. doi: 10.1007/s12325-019-01027-z. Epub 2019 Aug 1. PubMed 31372961 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03193957
Lead sponsor
Samsung Bioepis Co., Ltd.
Responsible party
Sponsor
First posted
Jun 21, 2017
Start date
May 15, 2017
Primary completion
Aug 3, 2017
Completion
Sep 25, 2017
Last update
Oct 13, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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