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Trial record 2 of 10 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

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ClinicalTrials.gov Identifier: NCT02565810
Recruitment Status : Completed
First Posted : October 1, 2015
Results First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Tracking Information
First Submitted Date  ICMJE September 23, 2015
First Posted Date  ICMJE October 1, 2015
Results First Submitted Date  ICMJE May 14, 2018
Results First Posted Date  ICMJE April 1, 2019
Last Update Posted Date April 1, 2019
Study Start Date  ICMJE September 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2018)
The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale [ Time Frame: Difference of injection site pain score (Week 6 - Week 2) ]
Injection site pain evaluation questionnaire will be rated on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (pain as bad as it could be) at two-time points post-injection (immediately post-injection and between 15 to 30 minutes post-injection) at Weeks 0, 2, 4, and 6.
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
Change in Injection site pain [ Time Frame: at Week 2 and at Week 6 ]
Change History Complete list of historical versions of study NCT02565810 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2018)
  • Overall Impression of SC Delivery Administration of SB5 Using Questionnaire [ Time Frame: at Week 2 and at Week 6 ]
    Objective: To evaluate whether overall impressions of SC administrations at Week 2 and Week 6 were comparable between the SC administrations of SB5 via the Pen and via the PFS.
  • Subject Preference of SC Delivery Administration of SB5 Using Questionnaire [ Time Frame: at Week 6 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
  • Overall Impression of SC Delivery Administration of SB5 Using Questionnaire [ Time Frame: at Week 2 and at Week 6 ]
  • Subject Preference of SC Delivery Administration of SB5 Using Questionnaire [ Time Frame: at Week 6 ]
  • Incidence of AEs (graded as mild, moderate, and severe) and SAEs [ Time Frame: through study completion ]
  • Injection site assessment (redness, bruising, swelling, itching, pain) [ Time Frame: through study completion ]
  • Clinical laboratory value [ Time Frame: through study completion ]
  • Physical examination [ Time Frame: through study completion ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Drug: Adalimumab PFS and Pen
Study Arms  ICMJE Experimental: SB5 40mg
Intervention: Drug: Adalimumab PFS and Pen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2016)
49
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2015)
50
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02565810
Other Study ID Numbers  ICMJE SB5-G21-RA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samsung Bioepis Co., Ltd.
Study Sponsor  ICMJE Samsung Bioepis Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Samsung Bioepis Co., Ltd.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP