An 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

NCT ID: NCT02565810

Last Updated: 2019-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-03-31

Brief Summary

A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

SB5 40mg

Group Type: EXPERIMENTAL

Adalimumab PFS and Pen

Intervention Type: DRUG

Interventions

Adalimumab PFS and Pen

Intervention Type: DRUG

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 self-administering adalimumab treatment

4. Must be able to provide informed consent, which must be obtained prior to any study related procedures.

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:

1. History of congestive heart failure (New York Heart Association Class III/IV)

2. History of demyelinating disorders (such as multiple sclerosis or Guillain-Barré syndrome).

4. History of lymphoproliferative disease including lymphoma or melanoma.

5. Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Bioepis Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Gdynia

Gdynia, , Poland

Medica pro Familia Sp z o.o. S.K.A Oddzial Warszawa

Warsaw, , Poland

Countries

Poland

References

Ghil J, Zielinska A, Lee Y. Usability and safety of SB5 (an adalimumab biosimilar) prefilled syringe and autoinjector in patients with rheumatoid arthritis. Curr Med Res Opin. 2019 Mar;35(3):497-502. doi: 10.1080/03007995.2018.1560211. Epub 2019 Jan 17.

Reference Type: DERIVED

PMID: 30561229 (View on PubMed)

Other Identifiers

SB5-G21-RA

Identifier Type: -

Identifier Source: org_study_id