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

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ClinicalTrials.gov Identifier: NCT02167139
Recruitment Status : Completed
First Posted : June 18, 2014
Results First Posted : January 19, 2017
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

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)
Enrollment 544
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SB5 (Proposed Biosimilar to Adalimumab) Humira (Adalimumab) Humira (Adalimumab), Switch to SB5 Humira (Adalimumab), Continue as Humira
Hide Arm/Group Description SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to 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. From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50. From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
Period Title: Randomised, Double-blind
Started 271 273 0 0
Completed 254 254 0 0
Not Completed 17 19 0 0
Reason Not Completed
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 Title: Transition-extension
Started 254 0 125 129
Completed 248 0 117 124
Not Completed 6 0 8 5
Reason Not Completed
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
Arm/Group Title SB5 (Proposed Biosimilar to Adalimumab) Humira (Adalimumab) Total
Hide Arm/Group Description

SB5 40 mg every other week via subcutaneous injection

SB5 (proposed biosimilar to adalimumab)

Humira 40 mg every other week via subcutaneous injection

Humira (adalimumab)

SB5 (proposed biosimilar to adalimumab)

Total of all reporting groups
Overall Number of Baseline Participants 271 273 544
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 271 participants 273 participants 544 participants
49.8  (12.67) 52.5  (11.91) 51.2  (12.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 271 participants 273 participants 544 participants
Female
217
  80.1%
224
  82.1%
441
  81.1%
Male
54
  19.9%
49
  17.9%
103
  18.9%
1.Primary Outcome
Title American College of Rheumatology 20% Response Criteria (ACR20)
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SB5 (Proposed Biosimilar to Adalimumab) Humira (Adalimumab)
Hide Arm/Group Description:
SB5 40 mg every other week via subcutaneous injection up to Week 24
Humira 40 mg every other week via subcutaneous injection up to Week 24
Overall Number of Participants Analyzed 239 237
Measure Type: Number
Unit of Measure: percentage of participants
72.4 72.2
2.Secondary Outcome
Title ACR20
Hide Description [Not Specified]
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SB5 (Proposed Biosimilar to Adalimumab) Humira (Adalimumab), Switch to SB5 Humira (Adalimumab), Continue as Humira
Hide Arm/Group Description:
SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
Overall Number of Participants Analyzed 212 106 111
Measure Type: Number
Unit of Measure: percentage of participants
76.9 81.1 71.2
3.Secondary Outcome
Title American College of Rheumatology 50% Response Criteria (ACR50)
Hide Description [Not Specified]
Time Frame Week 24, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SB5 (Proposed Biosimilar to Adalimumab) at Week 24 Humira (Adalimumab) at Week 24 SB5 (Proposed Biosimilar to Adalimumab) at Week 52 Humira (Adalimumab), Switch to SB5 at Week 52 Humira (Adalimumab), Continue as Humira at Week 52
Hide Arm/Group Description:
SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to 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.
SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
Overall Number of Participants Analyzed 239 237 212 106 111
Measure Type: Number
Unit of Measure: percentage of participants
38.1 39.7 49.1 53.8 51.4
4.Secondary Outcome
Title Disease Activity Score Based on a 28 Joint Count (DAS28)
Hide Description [Not Specified]
Time Frame Week 24, Week 52
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SB5 (Proposed Biosimilar to Adalimumab) Humira (Adalimumab)
Hide Arm/Group Description SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to 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.
All-Cause Mortality
SB5 (Proposed Biosimilar to Adalimumab) Humira (Adalimumab)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/268 (0.00%)      0/273 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
SB5 (Proposed Biosimilar to Adalimumab) Humira (Adalimumab)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/268 (3.36%)      16/273 (5.86%)    
Blood and lymphatic system disorders     
Eosinophilia  0/268 (0.00%)  0 1/273 (0.37%)  1
Cardiac disorders     
Acute myocardial infarction  1/268 (0.37%)  1 0/273 (0.00%)  0
Cardiac arrest  0/268 (0.00%)  0 1/273 (0.37%)  1
Eye disorders     
Retinal oedema  1/268 (0.37%)  1 0/273 (0.00%)  0
Gastrointestinal disorders     
Femoral hernia, obstructive  1/268 (0.37%)  1 0/273 (0.00%)  0
Infections and infestations     
Escherichia urinary tract infection  1/268 (0.37%)  1 0/273 (0.00%)  0
Viral infection  1/268 (0.37%)  1 0/273 (0.00%)  0
Bronchitis  0/268 (0.00%)  0 1/273 (0.37%)  1
Bronchopneumonia  0/268 (0.00%)  0 1/273 (0.37%)  1
Pneumonia  0/268 (0.00%)  0 2/273 (0.73%)  2
Staphylococcal sepsis  0/268 (0.00%)  0 1/273 (0.37%)  1
Urinary tract infection  0/268 (0.00%)  0 1/273 (0.37%)  1
Injury, poisoning and procedural complications     
Craniocerebral injury  0/268 (0.00%)  0 1/273 (0.37%)  1
Ulna fracture  0/268 (0.00%)  0 1/273 (0.37%)  1
Vascular pseudoaneurysm  0/268 (0.00%)  0 1/273 (0.37%)  1
Musculoskeletal and connective tissue disorders     
Rheumatoid arthritis  1/268 (0.37%)  1 1/273 (0.37%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Small cell lung cancer  1/268 (0.37%)  1 0/273 (0.00%)  0
Glioblastoma multiforme  0/268 (0.00%)  0 1/273 (0.37%)  1
Lymphoma  0/268 (0.00%)  0 1/273 (0.37%)  1
Metastases to spine  0/268 (0.00%)  0 1/273 (0.37%)  1
Papillary thyroid cancer  0/268 (0.00%)  0 1/273 (0.37%)  1
Seminoma  0/268 (0.00%)  0 1/273 (0.37%)  1
Nervous system disorders     
Lumber radiculopathy  1/268 (0.37%)  1 0/273 (0.00%)  0
Multiple sclerosis  0/268 (0.00%)  0 1/273 (0.37%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1/268 (0.37%)  1 0/273 (0.00%)  0
Nasal inflammation  0/268 (0.00%)  0 1/273 (0.37%)  1
Pulmonary embolism  0/268 (0.00%)  0 1/273 (0.37%)  1
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SB5 (Proposed Biosimilar to Adalimumab) Humira (Adalimumab)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/268 (13.06%)      44/273 (16.12%)    
Infections and infestations     
Nasopharyngitis  24/268 (8.96%)  27 30/273 (10.99%)  34
Nervous system disorders     
Headache  11/268 (4.10%)  13 14/273 (5.13%)  15
1
Term from vocabulary, MedDRA (17.0)
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.
At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy of all such manuscripts and materials, and allow Sponsor sixty (60) days to review and comment on them.
Results Point of Contact
Name/Title: Director, Clinical Development
Organization: Samsung Bioepis
Phone: +82 31 8061 4534
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