An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis

Samsung Bioepis Co., Ltd0 sitesJuly 7, 2015

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Samsung Bioepis Co., Ltd
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 7, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Samsung Bioepis Co., Ltd

Eligibility Criteria

Inclusion Criteria

•1\. Are male or female aged 18–55 years at the time of signing the informed consent form.
•2\. Have been diagnosed as having RA according to the revised 1987 American College of Rheumatology (ACR) criteria for at least 6 months prior to Screening.
•3\. Subjects who are considered by the Investigator to be a suitable candidate for selfadministering adalimumab treatment
•4\. Must be able to provide informed consent, which must be obtained prior to any study related procedures.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 50
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•1\. Have been treated previously with any biologic agents including any tumour necrosis factor inhibitor.
•2\. Have a known hypersensitivity to human immunoglobulin proteins or other components of SB5\.
•3\. Have a current diagnosis of active tuberculosis (TB), have been recently exposed to a person with active TB, or are considered to have latent TB indicated by a positive QuantiFERON® Gold test result.
•4\. Have had a serious infection (such as sepsis, abscess, opportunistic infections or invasive fungal infection including histoplasmosis) or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to first dose of IP. Nonsignificant infections do not need to be considered exclusionary at the discretion of the Investigator.
•5\. Have a history of chronic or recurrent infection (such as chronic renal infection, chronic chest infection or recurrent urinary infection).
•6\. Have any of the following conditions:
•a. History of congestive heart failure (New York Heart Association Class III/IV)
•b. History of demyelinating disorders (such as multiple sclerosis or Guillain\-Barré syndrome).
•c. History of any malignancy (other than lymphoproliferative disease and melanoma, see Exclusion Criteria 10\.f) within the previous 5 years prior to Screening except completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
•d. History of lymphoproliferative disease including lymphoma or melanoma.