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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 25 April 2016
Main ID:  EUCTR2014-004887-39-PL
Date of registration: 07/07/2015
Prospective Registration: Yes
Primary sponsor: Samsung Bioepis Co., Ltd
Public title: A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis
Scientific 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
Date of first enrolment: 08/08/2015
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004887-39
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1  
Phase: 
Countries of recruitment
Poland
Contacts
Name: Information Desk   
Address:  107, Cheomdan-daero, Yeonsu-gu 406-840 Incheon Korea, Republic of
Telephone: +82 (32) 455 3114
Email: bioepisinfo@samsung.com
Affiliation:  Samsung Bioepis Co., Ltd.
Name: Information Desk   
Address:  107, Cheomdan-daero, Yeonsu-gu 406-840 Incheon Korea, Republic of
Telephone: +82 (32) 455 3114
Email: bioepisinfo@samsung.com
Affiliation:  Samsung Bioepis Co., Ltd.
Key inclusion & exclusion 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.
e. Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC).
MedDRA version: 18.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Intervention(s)

Product Code: SB5
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: SB5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Product Code: SB5
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: SB5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)
Main Objective: The primary objective of this study is to demonstrate the comparability between subcutaneous (SC) delivery administration of SB5 via the pre-filled pen (Pen) versus the pre-filled syringe (PFS) in terms of injection site pain in subjects with rheumatoid arthritis (RA).
Primary end point(s): Injection site pain evaluation
Secondary Objective: The secondary objectives are:
• To assess the usability between SC delivery administration of SB5 via Pen versus PFS
• To assess the safety of SB5 via Pen and PFS
Timepoint(s) of evaluation of this end point: at Week 2 and at Week 6
Secondary Outcome(s)
Secondary end point(s): • Overall impression of SC delivery administration of SB5 using questionnaire at Weeks 2 and 6
• Subject preference of SC delivery administration of SB5 using questionnaire at Week 6

Safety endpoints
• Incidence of AEs (graded as mild, moderate, and severe)
• Incidence of serious AEs (SAEs)
• Injection site assessment
• Clinical laboratory value
• Physical examination
• Vital signs
Timepoint(s) of evaluation of this end point: Overall impression - at Weeks 2 and 6
Subject preference - at Week 6
Safety endpoints - during the trial
Secondary ID(s)
NCT02326233
SB5-G21-RA
Source(s) of Monetary Support
Samsung Bioepis Co., Ltd
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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