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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.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Rheumatoid Arthritis
Intervention Drug: Adalimumab PFS and Pen
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SB5 40mg
Hide Arm/Group Description Adalimumab PFS and Pen
Period Title: Overall Study
Started 49
Completed 48
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title SB5 40mg
Hide Arm/Group Description Adalimumab PFS and Pen
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants
40.9  (9.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
39
  79.6%
Male
10
  20.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
49
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
49
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Height (cm)  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 49 participants
167.69  (8.799)
1.Primary Outcome
Title The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale
Hide Description 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.
Time Frame Difference of injection site pain score (Week 6 - Week 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SB5 Pen/PFS
Hide Arm/Group Description:
Injection via PFS at Week 0 and Week 2 and then injection via Pen st Week 4 and then every other week thereafter up to Week 10
Overall Number of Participants Analyzed 49
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: Difference (scores on a scale)
Immediately post-injection
-0.35
(-0.99 to 0.30)
15-30 min post-injection
-0.11
(-0.47 to 0.25)
2.Secondary Outcome
Title Overall Impression of SC Delivery Administration of SB5 Using Questionnaire
Hide Description 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.
Time Frame at Week 2 and at Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Only number of subjects with available assessment results at each visit were counted as 'Overall number of participants analyzed'.
Arm/Group Title Week 2 (SB5 40 mg PFS) Week 6 (SB5 40 mg Pen)
Hide Arm/Group Description:
40 mg sc injection via PFS at Week 0 and Week 2 and then 40 mg sc injection via Pen st Week 4 and then every other week thereafter up to Week 10.
40 mg sc injection via PFS at Week 0 and Week 2 and then 40 mg sc injection via Pen st Week 4 and then every other week thereafter up to Week 10.
Overall Number of Participants Analyzed 48 46
Measure Type: Count of Participants
Unit of Measure: Participants
Extremely Favorable
1
   2.1%
3
   6.5%
Favorable
13
  27.1%
15
  32.6%
Neutral
31
  64.6%
21
  45.7%
Unfavorable
3
   6.3%
7
  15.2%
Extremely Unfavorable
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Subject Preference of SC Delivery Administration of SB5 Using Questionnaire
Hide Description [Not Specified]
Time Frame at Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed means number of subjects with available assessment results
Arm/Group Title SB5 PFS SB5 Pen No Preference
Hide Arm/Group Description:
Subject preference for the PFS at Week 6
Subject preference for the Pen at Week 6
Subject who chose 'no preference' at Week 6
Overall Number of Participants Analyzed 46 46 46
Measure Type: Number
Unit of Measure: number of responders
Overall Preference 14 26 6
Category: Ease of Use 10 33 3
Category: Convenience 6 35 5
Category: Time to Administer Injection 9 30 7
Category: Safety 6 31 9
Category: Less Pain 17 21 8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SB5 40mg
Hide Arm/Group Description Adalimumab PFS and Pen
All-Cause Mortality
SB5 40mg
Affected / at Risk (%)
Total   0/49 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
SB5 40mg
Affected / at Risk (%) # Events
Total   0/49 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SB5 40mg
Affected / at Risk (%) # Events
Total   4/49 (8.16%)    
Infections and infestations   
Nasopharyngitis   4/49 (8.16%)  4
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Trials
Organization: Samsung Bioepis Co., Ltd.
EMail: sbregistry@samsung.com
Layout table for additonal information
Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT02565810     History of Changes
Other Study ID Numbers: SB5-G21-RA
First Submitted: September 23, 2015
First Posted: October 1, 2015
Results First Submitted: May 14, 2018
Results First Posted: April 1, 2019
Last Update Posted: April 1, 2019