ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 9 for:    SB5

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

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: NCT02565810
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Adalimumab PFS and Pen Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Study Start Date : September 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: SB5 40mg Drug: Adalimumab PFS and Pen



Primary Outcome Measures :
  1. Change in Injection site pain using questionnaire [ Time Frame: at Week 2 and at Week 6 ]

Secondary Outcome Measures :
  1. Overall impression of SC delivery administration of SB5 using questionnaire [ Time Frame: at Week 2 and at Week 6 ]
  2. Subject preference of SC delivery administration of SB5 using questionnaire [ Time Frame: at Week 6 ]
  3. Incidence of AEs (graded as mild, moderate, and severe) and SAEs [ Time Frame: through study completion ]
  4. Injection site assessment (redness, bruising, swelling, itching, pain) [ Time Frame: through study completion ]
  5. Clinical laboratory value [ Time Frame: through study completion ]
  6. Physical examination [ Time Frame: through study completion ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
    3. 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.
    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.

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): NCT02565810


Locations
Poland
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
Warszawa, Poland
Sponsors and Collaborators
Samsung Bioepis Co., Ltd.

Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT02565810     History of Changes
Other Study ID Numbers: SB5-G21-RA
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: April 2016

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents