MedDataX Logo

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

NCT ID: NCT03193957

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2017-09-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SB4

SB4 (etanercept) 50 mg/mL

Group Type EXPERIMENTAL

Etanercept

Intervention Type DRUG

Etanercept PFS and Autoinjector

Autoinjector

Intervention Type DEVICE

Autoinjector

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Etanercept

Etanercept PFS and Autoinjector

Intervention Type DRUG

Autoinjector

Autoinjector

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Samsung Bioepis Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AI Centrum Medyczne

Poznan, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31372961 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SB4-G21-RA

Identifier Type: -

Identifier Source: org_study_id