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A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02167139
First Posted: June 18, 2014
Last Update Posted: August 17, 2017
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.
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.
Results First Submitted: November 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Humira (adalimumab)
Drug: SB5 (proposed biosimilar to adalimumab)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
SB5 (Proposed Biosimilar to Adalimumab) SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
Humira (Adalimumab) Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
Humira (Adalimumab), Switch to SB5 From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
Humira (Adalimumab), Continue as Humira From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.

Participant Flow for 2 periods

Period 1:   Randomised, Double-blind
    SB5 (Proposed Biosimilar to Adalimumab)   Humira (Adalimumab)   Humira (Adalimumab), Switch to SB5   Humira (Adalimumab), Continue as Humira
STARTED   271   273   0   0 
COMPLETED   254   254   0   0 
NOT COMPLETED   17   19   0   0 
Withdrawal by Subject                11                8                0                0 
Adverse Event                2                9                0                0 
Lack of Efficacy                1                2                0                0 
Other                3                0                0                0 

Period 2:   Transition-extension
    SB5 (Proposed Biosimilar to Adalimumab)   Humira (Adalimumab)   Humira (Adalimumab), Switch to SB5   Humira (Adalimumab), Continue as Humira
STARTED   254   0   125   129 
COMPLETED   248   0   117   124 
NOT COMPLETED   6   0   8   5 
Adverse Event                2                0                2                3 
Withdrawal by Subject                2                0                4                1 
Lack of Efficacy                0                0                1                1 
Other                1                0                1                0 
Lost to Follow-up                1                0                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
SB5 (Proposed Biosimilar to Adalimumab)

SB5 40 mg every other week via subcutaneous injection

SB5 (proposed biosimilar to adalimumab)

Humira (Adalimumab)

Humira 40 mg every other week via subcutaneous injection

Humira (adalimumab)

SB5 (proposed biosimilar to adalimumab)

Total Total of all reporting groups

Baseline Measures
   SB5 (Proposed Biosimilar to Adalimumab)   Humira (Adalimumab)   Total 
Overall Participants Analyzed 
[Units: Participants]
 271   273   544 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.8  (12.67)   52.5  (11.91)   51.2  (12.36) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      217  80.1%      224  82.1%      441  81.1% 
Male      54  19.9%      49  17.9%      103  18.9% 


  Outcome Measures
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1.  Primary:   American College of Rheumatology 20% Response Criteria (ACR20)   [ Time Frame: Week 24 ]

2.  Secondary:   ACR20   [ Time Frame: Week 52 ]

3.  Secondary:   American College of Rheumatology 50% Response Criteria (ACR50)   [ Time Frame: Week 24, Week 52 ]

4.  Secondary:   Disease Activity Score Based on a 28 Joint Count (DAS28)   [ Time Frame: Week 24, Week 52 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
SB5 (Proposed Biosimilar to Adalimumab) SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
Humira (Adalimumab) Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.

Other Adverse Events
    SB5 (Proposed Biosimilar to Adalimumab)   Humira (Adalimumab)
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   35/268 (13.06%)   44/273 (16.12%) 
Infections and infestations     
Nasopharyngitis     
# participants affected / at risk   24/268 (8.96%)   30/273 (10.99%) 
# events   27   34 
Nervous system disorders     
Headache     
# participants affected / at risk   11/268 (4.10%)   14/273 (5.13%) 
# events   13   15 
1 Term from vocabulary, MedDRA (17.0)



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director, Clinical Development
Organization: Samsung Bioepis
phone: +82 31 8061 4534
e-mail: dh01.shin@samsung.com



Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT02167139     History of Changes
Other Study ID Numbers: SB5-G31-RA
First Submitted: June 16, 2014
First Posted: June 18, 2014
Results First Submitted: November 22, 2016
Results First Posted: January 19, 2017
Last Update Posted: August 17, 2017