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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03193957
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Etanercept Device: Autoinjector Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : August 3, 2017
Actual Study Completion Date : September 25, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Arm Intervention/treatment
Experimental: SB4
SB4 (etanercept) 50 mg/mL
Drug: Etanercept
Etanercept PFS and Autoinjector

Device: Autoinjector
Autoinjector




Primary Outcome Measures :
  1. The change in Injection site pain score at immediately post injection (within 1 minute) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193957


Locations
Poland
AI Centrum Medyczne
Poznań, Poland
Sponsors and Collaborators
Samsung Bioepis Co., Ltd.

Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT03193957     History of Changes
Other Study ID Numbers: SB4-G21-RA
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors