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A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

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ClinicalTrials.gov Identifier: NCT01895309
Recruitment Status : Completed
First Posted : July 10, 2013
Results First Posted : August 29, 2016
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: Enbrel (etanercept)
Drug: SB4 (proposed biosimilar to etanercept)
Enrollment 596
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SB4 (Proposed Biosimilar to Etanercept) Enbrel (Etanercept)
Hide Arm/Group Description SB4 50 mg/week via subcutaneous injection Enbrel 50 mg/week via subcutaneous injection
Period Title: Overall Study
Started 299 297
Completed 259 246
Not Completed 40 51
Reason Not Completed
Adverse Event             13             17
Protocol Violation             1             0
Lack of Efficacy             1             3
Lost to Follow-up             1             3
Physician Decision             15             10
Withdrawal by Subject             9             18
Arm/Group Title SB4 (Proposed Biosimilar to Etanercept) Enbrel (Etanercept) Total
Hide Arm/Group Description SB4 50 mg/week via subcutaneous injection Enbrel 50 mg/week via subcutaneous injection Total of all reporting groups
Overall Number of Baseline Participants 299 297 596
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 299 participants 297 participants 596 participants
52.1  (11.72) 51.6  (11.63) 51.8  (11.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 299 participants 297 participants 596 participants
Female
249
  83.3%
253
  85.2%
502
  84.2%
Male
50
  16.7%
44
  14.8%
94
  15.8%
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 SB4 (Proposed Biosimilar to Etanercept) Enbrel (Etanercept)
Hide Arm/Group Description:
SB4 50 mg/week via subcutaneous injection
Enbrel 50 mg/week via subcutaneous injection
Overall Number of Participants Analyzed 247 236
Measure Type: Number
Unit of Measure: percentage of participants
78.1 80.5
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 SB4 (Proposed Biosimilar to Etanercept) Enbrel (Etanercept)
Hide Arm/Group Description:
SB4 50 mg/week via subcutaneous injection
Enbrel 50 mg/week via subcutaneous injection
Overall Number of Participants Analyzed 224 216
Measure Type: Number
Unit of Measure: percentage of participants
80.8 81.5
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 SB4 (Proposed Biosimilar to Etanercept) at Week 24 Enbrel (Etanercept) at Week 24 SB4 (Proposed Biosimilar to Etanercept) at Week 52 Enbrel (Etanercept) at Week 52
Hide Arm/Group Description:

SB4 50 mg/week via subcutaneous injection

SB4 (proposed biosimilar to etanercept)

Enbrel 50 mg/week via subcutaneous injection

Enbrel (etanercept)

SB4 50 mg/week via subcutaneous injection

SB4 (proposed biosimilar to etanercept)

Enbrel 50 mg/week via subcutaneous injection

Enbrel (etanercept)

Overall Number of Participants Analyzed 247 236 224 216
Measure Type: Number
Unit of Measure: percentage of participants
46.2 42.4 58.5 53.2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SB4 (Proposed Biosimilar to Etanercept) Enbrel (Etanercept)
Hide Arm/Group Description

SB4 50 mg/week via subcutaneous injection

SB4 (proposed biosimilar to etanercept)

Enbrel 50 mg/week via subcutaneous injection

Enbrel (etanercept)

All-Cause Mortality
SB4 (Proposed Biosimilar to Etanercept) Enbrel (Etanercept)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SB4 (Proposed Biosimilar to Etanercept) Enbrel (Etanercept)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/299 (6.02%)      15/297 (5.05%)    
Blood and lymphatic system disorders     
Neutropenia  0/299 (0.00%)  0 1/297 (0.34%)  1
Cardiac disorders     
Acute Myocardial Infarction  1/299 (0.33%)  1 0/297 (0.00%)  0
Atrial Fibrillation  1/299 (0.33%)  1 0/297 (0.00%)  0
Cardiopulmonary Failure  1/299 (0.33%)  1 0/297 (0.00%)  0
Coronary Artery Disease  0/299 (0.00%)  0 1/297 (0.34%)  1
Eye disorders     
Chorioretinopathy  0/299 (0.00%)  0 1/297 (0.34%)  1
Gastrointestinal disorders     
Enterocolitis  0/299 (0.00%)  0 1/297 (0.34%)  1
Gastritis  0/299 (0.00%)  0 1/297 (0.34%)  1
Gastrooesophageal Reflux Disease  0/299 (0.00%)  0 1/297 (0.34%)  1
General disorders     
Device Failure  1/299 (0.33%)  1 0/297 (0.00%)  0
Hepatobiliary disorders     
Bile Duct Stone  1/299 (0.33%)  2 0/297 (0.00%)  0
Cholangitis  1/299 (0.33%)  1 0/297 (0.00%)  0
Cholecystitis  1/299 (0.33%)  1 0/297 (0.00%)  0
Cholelithiasis  1/299 (0.33%)  1 0/297 (0.00%)  0
Gallbladder Perforation  1/299 (0.33%)  1 0/297 (0.00%)  0
Infections and infestations     
Liver Abscess  1/299 (0.33%)  1 0/297 (0.00%)  0
Peritonitis  1/299 (0.33%)  1 0/297 (0.00%)  0
Appendicitis  0/299 (0.00%)  0 1/297 (0.34%)  1
Cellulitis  0/299 (0.00%)  0 2/297 (0.67%)  2
Erysipelas  0/299 (0.00%)  0 1/297 (0.34%)  1
Pneumonia  0/299 (0.00%)  0 1/297 (0.34%)  1
Injury, poisoning and procedural complications     
Femoral Neck Fracture  0/299 (0.00%)  0 1/297 (0.34%)  1
Musculoskeletal and connective tissue disorders     
Rheumatoid Arthritis  1/299 (0.33%)  1 1/297 (0.34%)  1
Still'S Disease Adult Onset  1/299 (0.33%)  2 0/297 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma Gastric  1/299 (0.33%)  1 0/297 (0.00%)  0
Breast Cancer  1/299 (0.33%)  1 0/297 (0.00%)  0
Lung Cancer Metastatic  1/299 (0.33%)  1 0/297 (0.00%)  0
Invasive Ductal Breast Carcinoma  0/299 (0.00%)  0 1/297 (0.34%)  1
Nervous system disorders     
Syncope  1/299 (0.33%)  1 0/297 (0.00%)  0
Reproductive system and breast disorders     
Ovarian Cyst  1/299 (0.33%)  1 0/297 (0.00%)  0
Uterine Polyp  1/299 (0.33%)  1 0/297 (0.00%)  0
Vaginal Prolapse  1/299 (0.33%)  1 0/297 (0.00%)  0
Skin and subcutaneous tissue disorders     
Psoriasis  1/299 (0.33%)  1 0/297 (0.00%)  0
Vascular disorders     
Hypertensive Crisis  0/299 (0.00%)  0 1/297 (0.34%)  1
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SB4 (Proposed Biosimilar to Etanercept) Enbrel (Etanercept)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   175/299 (58.53%)      179/297 (60.27%)    
Blood and lymphatic system disorders     
Leukopenia  6/299 (2.01%)  7 3/297 (1.01%)  4
Anaemia  5/299 (1.67%)  5 3/297 (1.01%)  4
Neutropenia  4/299 (1.34%)  4 5/297 (1.68%)  7
Thrombocytopenia  3/299 (1.00%)  3 0/297 (0.00%)  0
Lymphopenia  2/299 (0.67%)  2 4/297 (1.35%)  4
Anaemia Of Chronic Disease  1/299 (0.33%)  1 0/297 (0.00%)  0
Lymphadenopathy  0/299 (0.00%)  0 3/297 (1.01%)  4
Cardiac disorders     
Tachycardia  2/299 (0.67%)  2 1/297 (0.34%)  1
Acute Myocardial Infarction  1/299 (0.33%)  1 0/297 (0.00%)  0
Atrial Fibrillation  1/299 (0.33%)  1 0/297 (0.00%)  0
Cardiopulmonary Failure  1/299 (0.33%)  1 0/297 (0.00%)  0
Cardiac Failure Congestive  0/299 (0.00%)  0 1/297 (0.34%)  1
Cardiovascular Insufficiency  0/299 (0.00%)  0 1/297 (0.34%)  1
Coronary Artery Disease  0/299 (0.00%)  0 1/297 (0.34%)  1
Mitral Valve Prolapse  0/299 (0.00%)  0 1/297 (0.34%)  1
Palpitations  0/299 (0.00%)  0 2/297 (0.67%)  2
Ear and labyrinth disorders     
Vertigo  3/299 (1.00%)  3 1/297 (0.34%)  1
Hypoacusis  1/299 (0.33%)  1 0/297 (0.00%)  0
Ear Pain  0/299 (0.00%)  0 1/297 (0.34%)  1
External Ear Inflammation  0/299 (0.00%)  0 2/297 (0.67%)  2
Tinnitus  0/299 (0.00%)  0 1/297 (0.34%)  1
Endocrine disorders     
Goitre  1/299 (0.33%)  1 1/297 (0.34%)  1
Thyroid Cyst  0/299 (0.00%)  0 1/297 (0.34%)  1
Eye disorders     
Eyelid Oedema  2/299 (0.67%)  3 0/297 (0.00%)  0
Conjunctival Haemorrhage  1/299 (0.33%)  1 1/297 (0.34%)  1
Conjunctivitis  1/299 (0.33%)  1 0/297 (0.00%)  0
Dry Eye  1/299 (0.33%)  1 1/297 (0.34%)  1
Eye Irritation  1/299 (0.33%)  1 0/297 (0.00%)  0
Eyelid Ptosis  1/299 (0.33%)  1 0/297 (0.00%)  0
Vision Blurred  1/299 (0.33%)  1 0/297 (0.00%)  0
Cataract  0/299 (0.00%)  0 1/297 (0.34%)  1
Chorioretinopathy  0/299 (0.00%)  0 1/297 (0.34%)  1
Presbyopia  0/299 (0.00%)  0 1/297 (0.34%)  1
Gastrointestinal disorders     
Diarrhoea  5/299 (1.67%)  5 7/297 (2.36%)  8
Abdominal Pain Upper  4/299 (1.34%)  5 4/297 (1.35%)  4
Nausea  4/299 (1.34%)  8 1/297 (0.34%)  2
Abdominal Pain  2/299 (0.67%)  2 3/297 (1.01%)  4
Dyspepsia  2/299 (0.67%)  2 4/297 (1.35%)  4
Abdominal Pain Lower  1/299 (0.33%)  1 0/297 (0.00%)  0
Constipation  1/299 (0.33%)  1 0/297 (0.00%)  0
Diverticulum Intestinal  1/299 (0.33%)  1 1/297 (0.34%)  1
Enterocele  1/299 (0.33%)  1 0/297 (0.00%)  0
Gastrooesophageal Reflux Disease  1/299 (0.33%)  1 2/297 (0.67%)  2
Irritable Bowel Syndrome  1/299 (0.33%)  1 0/297 (0.00%)  0
Parotid Gland Inflammation  1/299 (0.33%)  1 0/297 (0.00%)  0
Colitis  0/299 (0.00%)  0 1/297 (0.34%)  1
Dry Mouth  0/299 (0.00%)  0 1/297 (0.34%)  1
Enterocolitis  0/299 (0.00%)  0 1/297 (0.34%)  1
Flatulence  0/299 (0.00%)  0 2/297 (0.67%)  2
Gastric Ulcer  0/299 (0.00%)  0 1/297 (0.34%)  1
Gastritis  0/299 (0.00%)  0 4/297 (1.35%)  5
Gastrointestinal Disorder  0/299 (0.00%)  0 1/297 (0.34%)  1
Haemorrhoids  0/299 (0.00%)  0 2/297 (0.67%)  2
Portal Hypertensive Gastropathy  0/299 (0.00%)  0 1/297 (0.34%)  1
Reflux Gastritis  0/299 (0.00%)  0 1/297 (0.34%)  1
Retching  0/299 (0.00%)  0 1/297 (0.34%)  1
Stomatitis  0/299 (0.00%)  0 1/297 (0.34%)  1
Vomiting  0/299 (0.00%)  0 3/297 (1.01%)  3
General disorders     
Injection Site Erythema  6/299 (2.01%)  16 33/297 (11.11%)  85
Influenza Like Illness  3/299 (1.00%)  5 1/297 (0.34%)  1
Oedema Peripheral  3/299 (1.00%)  3 3/297 (1.01%)  4
Asthenia  2/299 (0.67%)  2 5/297 (1.68%)  5
Chest Pain  2/299 (0.67%)  3 2/297 (0.67%)  3
Chills  2/299 (0.67%)  2 0/297 (0.00%)  0
Fatigue  2/299 (0.67%)  2 4/297 (1.35%)  4
Injection Site Rash  2/299 (0.67%)  2 6/297 (2.02%)  11
Pain  2/299 (0.67%)  2 1/297 (0.34%)  1
Spinal Pain  2/299 (0.67%)  3 1/297 (0.34%)  1
Device Failure  1/299 (0.33%)  1 0/297 (0.00%)  0
Injection Site Haematoma  1/299 (0.33%)  1 0/297 (0.00%)  0
Injection Site Hypersensitivity  1/299 (0.33%)  1 2/297 (0.67%)  10
Injection Site Pruritus  1/299 (0.33%)  1 4/297 (1.35%)  6
Injection Site Reaction  1/299 (0.33%)  1 8/297 (2.69%)  13
Pyrexia  1/299 (0.33%)  1 2/297 (0.67%)  3
Application Site Erythema  0/299 (0.00%)  0 3/297 (1.01%)  18
Application Site Reaction  0/299 (0.00%)  0 1/297 (0.34%)  1
Face Oedema  0/299 (0.00%)  0 1/297 (0.34%)  1
Feeling Hot  0/299 (0.00%)  0 1/297 (0.34%)  1
Injection Site Bruising  0/299 (0.00%)  0 1/297 (0.34%)  1
Injection Site Dermatitis  0/299 (0.00%)  0 1/297 (0.34%)  2
Injection Site Inflammation  0/299 (0.00%)  0 2/297 (0.67%)  2
Injection Site Oedema  0/299 (0.00%)  0 3/297 (1.01%)  6
Injection Site Pain  0/299 (0.00%)  0 1/297 (0.34%)  1
Injection Site Swelling  0/299 (0.00%)  0 1/297 (0.34%)  1
Malaise  0/299 (0.00%)  0 2/297 (0.67%)  3
Soft Tissue Inflammation  0/299 (0.00%)  0 1/297 (0.34%)  1
Hepatobiliary disorders     
Cholelithiasis  4/299 (1.34%)  4 0/297 (0.00%)  0
Liver Disorder  3/299 (1.00%)  3 0/297 (0.00%)  0
Cholecystitis Chronic  2/299 (0.67%)  3 0/297 (0.00%)  0
Bile Duct Stone  1/299 (0.33%)  2 0/297 (0.00%)  0
Biliary Colic  1/299 (0.33%)  1 0/297 (0.00%)  0
Cholangitis  1/299 (0.33%)  1 0/297 (0.00%)  0
Cholecystitis  1/299 (0.33%)  1 0/297 (0.00%)  0
Gallbladder Perforation  1/299 (0.33%)  1 0/297 (0.00%)  0
Hypertransaminasaemia  1/299 (0.33%)  1 0/297 (0.00%)  0
Immune system disorders     
Allergy To Arthropod Bite  1/299 (0.33%)  1 0/297 (0.00%)  0
Hypersensitivity  0/299 (0.00%)  0 1/297 (0.34%)  1
Infections and infestations     
Upper Respiratory Tract Infection  24/299 (8.03%)  28 16/297 (5.39%)  18
Nasopharyngitis  15/299 (5.02%)  17 16/297 (5.39%)  17
Viral Infection  7/299 (2.34%)  7 5/297 (1.68%)  5
Bronchitis  6/299 (2.01%)  6 6/297 (2.02%)  6
Rhinitis  6/299 (2.01%)  6 4/297 (1.35%)  5
Pharyngitis  5/299 (1.67%)  5 8/297 (2.69%)  9
Urinary Tract Infection  5/299 (1.67%)  5 7/297 (2.36%)  9
Oral Herpes  4/299 (1.34%)  7 5/297 (1.68%)  6
Herpes Zoster  3/299 (1.00%)  5 1/297 (0.34%)  1
Asymptomatic Bacteriuria  2/299 (0.67%)  3 0/297 (0.00%)  0
Ear Infection  2/299 (0.67%)  2 0/297 (0.00%)  0
Otitis Externa  2/299 (0.67%)  2 0/297 (0.00%)  0
Pharyngotonsillitis  2/299 (0.67%)  2 1/297 (0.34%)  1
Pneumonia  2/299 (0.67%)  2 1/297 (0.34%)  1
Sinusitis  2/299 (0.67%)  2 1/297 (0.34%)  1
Viral Upper Respiratory Tract Infection  2/299 (0.67%)  2 3/297 (1.01%)  3
Acute Tonsillitis  1/299 (0.33%)  1 0/297 (0.00%)  0
Bacteriuria  1/299 (0.33%)  1 0/297 (0.00%)  0
Cellulitis  1/299 (0.33%)  1 2/297 (0.67%)  2
Chronic Tonsillitis  1/299 (0.33%)  1 0/297 (0.00%)  0
Diverticulitis  1/299 (0.33%)  1 0/297 (0.00%)  0
Erysipelas  1/299 (0.33%)  1 1/297 (0.34%)  1
Fungal Infection  1/299 (0.33%)  1 0/297 (0.00%)  0
Furuncle  1/299 (0.33%)  1 0/297 (0.00%)  0
Gastroenteritis  1/299 (0.33%)  1 2/297 (0.67%)  2
Herpes Simplex  1/299 (0.33%)  1 2/297 (0.67%)  2
Liver Abscess  1/299 (0.33%)  1 0/297 (0.00%)  0
Localised Infection  1/299 (0.33%)  1 0/297 (0.00%)  0
Lyme Disease  1/299 (0.33%)  1 0/297 (0.00%)  0
Otitis Media  1/299 (0.33%)  1 1/297 (0.34%)  1
Peritonitis  1/299 (0.33%)  1 0/297 (0.00%)  0
Pharyngitis Bacterial  1/299 (0.33%)  1 0/297 (0.00%)  0
Pyelonephritis  1/299 (0.33%)  1 1/297 (0.34%)  1
Rash Pustular  1/299 (0.33%)  1 0/297 (0.00%)  0
Respiratory Tract Infection  1/299 (0.33%)  1 1/297 (0.34%)  1
Tinea Pedis  1/299 (0.33%)  1 1/297 (0.34%)  1
Tinea Versicolour  1/299 (0.33%)  1 1/297 (0.34%)  1
Tonsillitis  1/299 (0.33%)  1 2/297 (0.67%)  2
Tooth Infection  1/299 (0.33%)  1 0/297 (0.00%)  0
Tracheobronchitis  1/299 (0.33%)  1 0/297 (0.00%)  0
Acute Sinusitis  0/299 (0.00%)  0 1/297 (0.34%)  1
Appendicitis  0/299 (0.00%)  0 1/297 (0.34%)  1
Eczema Infected  0/299 (0.00%)  0 1/297 (0.34%)  1
Gingivitis  0/299 (0.00%)  0 1/297 (0.34%)  2
Herpes Virus Infection  0/299 (0.00%)  0 1/297 (0.34%)  2
Influenza  0/299 (0.00%)  0 1/297 (0.34%)  1
Laryngitis  0/299 (0.00%)  0 1/297 (0.34%)  1
Lobar Pneumonia  0/299 (0.00%)  0 1/297 (0.34%)  1
Nail Candida  0/299 (0.00%)  0 1/297 (0.34%)  1
Onychomycosis  0/299 (0.00%)  0 1/297 (0.34%)  1
Periodontitis  0/299 (0.00%)  0 1/297 (0.34%)  1
Peritonitis Bacterial  0/299 (0.00%)  0 1/297 (0.34%)  1
Pulpitis Dental  0/299 (0.00%)  0 1/297 (0.34%)  1
Sialoadenitis  0/299 (0.00%)  0 1/297 (0.34%)  1
Viral Rhinitis  0/299 (0.00%)  0 1/297 (0.34%)  2
Vulvovaginal Candidiasis  0/299 (0.00%)  0 1/297 (0.34%)  1
Injury, poisoning and procedural complications     
Contusion  2/299 (0.67%)  3 1/297 (0.34%)  1
Head Injury  2/299 (0.67%)  2 0/297 (0.00%)  0
Arthropod Bite  1/299 (0.33%)  1 0/297 (0.00%)  0
Hand Fracture  1/299 (0.33%)  1 0/297 (0.00%)  0
Joint Dislocation  1/299 (0.33%)  1 0/297 (0.00%)  0
Joint Injury  1/299 (0.33%)  1 0/297 (0.00%)  0
Ligament Sprain  1/299 (0.33%)  1 1/297 (0.34%)  1
Muscle Strain  1/299 (0.33%)  1 0/297 (0.00%)  0
Traumatic Fracture  1/299 (0.33%)  1 0/297 (0.00%)  0
Fall  0/299 (0.00%)  0 1/297 (0.34%)  1
Femoral Neck Fracture  0/299 (0.00%)  0 1/297 (0.34%)  1
Fibula Fracture  0/299 (0.00%)  0 1/297 (0.34%)  1
Injection Related Reaction  0/299 (0.00%)  0 1/297 (0.34%)  2
Injury  0/299 (0.00%)  0 1/297 (0.34%)  2
Limb Injury  0/299 (0.00%)  0 1/297 (0.34%)  2
Lumbar Vertebral Fracture  0/299 (0.00%)  0 2/297 (0.67%)  2
Thermal Burn  0/299 (0.00%)  0 1/297 (0.34%)  1
Investigations     
Alanine Aminotransferase Increased  18/299 (6.02%)  25 17/297 (5.72%)  26
Aspartate Aminotransferase Increased  8/299 (2.68%)  13 9/297 (3.03%)  10
Gamma-Glutamyltransferase Increased  5/299 (1.67%)  11 5/297 (1.68%)  6
Lymphocyte Count Decreased  4/299 (1.34%)  4 6/297 (2.02%)  8
Transaminases Increased  4/299 (1.34%)  5 4/297 (1.35%)  4
Blood Pressure Increased  3/299 (1.00%)  4 3/297 (1.01%)  3
Liver Function Test Abnormal  3/299 (1.00%)  4 2/297 (0.67%)  2
Blood Alkaline Phosphatase Increased  2/299 (0.67%)  4 0/297 (0.00%)  0
Blood Glucose Increased  2/299 (0.67%)  2 0/297 (0.00%)  0
Hepatic Enzyme Increased  2/299 (0.67%)  4 0/297 (0.00%)  0
Neutrophil Count Decreased  2/299 (0.67%)  2 1/297 (0.34%)  1
White Blood Cell Count Decreased  2/299 (0.67%)  2 1/297 (0.34%)  1
Blood Urine Present  1/299 (0.33%)  1 0/297 (0.00%)  0
Haemoglobin Decreased  1/299 (0.33%)  1 0/297 (0.00%)  0
Neutrophil Count Increased  1/299 (0.33%)  1 0/297 (0.00%)  0
Nitrite Urine Present  1/299 (0.33%)  1 0/297 (0.00%)  0
Urine Analysis Abnormal  1/299 (0.33%)  1 0/297 (0.00%)  0
Weight Increased  1/299 (0.33%)  1 0/297 (0.00%)  0
Blood Calcium Decreased  0/299 (0.00%)  0 1/297 (0.34%)  2
Blood Phosphorus Decreased  0/299 (0.00%)  0 2/297 (0.67%)  3
Lymphocyte Count Abnormal  0/299 (0.00%)  0 1/297 (0.34%)  1
Lymphocyte Count Increased  0/299 (0.00%)  0 1/297 (0.34%)  1
Platelet Count Decreased  0/299 (0.00%)  0 1/297 (0.34%)  3
Platelet Count Increased  0/299 (0.00%)  0 1/297 (0.34%)  1
Metabolism and nutrition disorders     
Hypokalaemia  1/299 (0.33%)  1 0/297 (0.00%)  0
Dyslipidaemia  0/299 (0.00%)  0 1/297 (0.34%)  1
Hypercholesterolaemia  0/299 (0.00%)  0 2/297 (0.67%)  2
Hypoglycaemia  0/299 (0.00%)  0 1/297 (0.34%)  1
Metabolic Syndrome  0/299 (0.00%)  0 1/297 (0.34%)  1
Type 2 Diabetes Mellitus  0/299 (0.00%)  0 1/297 (0.34%)  1
Musculoskeletal and connective tissue disorders     
Rheumatoid Arthritis  9/299 (3.01%)  10 10/297 (3.37%)  11
Arthralgia  4/299 (1.34%)  5 5/297 (1.68%)  10
Back Pain  4/299 (1.34%)  5 4/297 (1.35%)  4
Arthritis  2/299 (0.67%)  2 1/297 (0.34%)  1
Musculoskeletal Pain  2/299 (0.67%)  2 1/297 (0.34%)  1
Pain In Extremity  2/299 (0.67%)  2 2/297 (0.67%)  2
Periarthritis  2/299 (0.67%)  2 0/297 (0.00%)  0
Bursitis  1/299 (0.33%)  1 0/297 (0.00%)  0
Fracture Delayed Union  1/299 (0.33%)  1 0/297 (0.00%)  0
Groin Pain  1/299 (0.33%)  2 0/297 (0.00%)  0
Musculoskeletal Chest Pain  1/299 (0.33%)  1 0/297 (0.00%)  0
Myalgia  1/299 (0.33%)  1 0/297 (0.00%)  0
Neck Pain  1/299 (0.33%)  1 1/297 (0.34%)  1
Osteoarthritis  1/299 (0.33%)  1 2/297 (0.67%)  2
Sjogren'S Syndrome  1/299 (0.33%)  1 0/297 (0.00%)  0
Still'S Disease Adult Onset  1/299 (0.33%)  2 0/297 (0.00%)  0
Synovitis  1/299 (0.33%)  1 0/297 (0.00%)  0
Tenosynovitis  1/299 (0.33%)  1 0/297 (0.00%)  0
Bone Pain  0/299 (0.00%)  0 1/297 (0.34%)  1
Enthesopathy  0/299 (0.00%)  0 1/297 (0.34%)  2
Fibromyalgia  0/299 (0.00%)  0 1/297 (0.34%)  1
Intervertebral Disc Disorder  0/299 (0.00%)  0 1/297 (0.34%)  1
Joint Swelling  0/299 (0.00%)  0 1/297 (0.34%)  1
Lumbar Spinal Stenosis  0/299 (0.00%)  0 1/297 (0.34%)  1
Muscle Spasms  0/299 (0.00%)  0 1/297 (0.34%)  1
Nuchal Rigidity  0/299 (0.00%)  0 1/297 (0.34%)  1
Osteopenia  0/299 (0.00%)  0 1/297 (0.34%)  1
Osteoporosis  0/299 (0.00%)  0 2/297 (0.67%)  2
Osteoporotic Fracture  0/299 (0.00%)  0 1/297 (0.34%)  1
Periostitis  0/299 (0.00%)  0 1/297 (0.34%)  1
Spinal Deformity  0/299 (0.00%)  0 1/297 (0.34%)  1
Spondylolisthesis  0/299 (0.00%)  0 1/297 (0.34%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine Leiomyoma  2/299 (0.67%)  2 1/297 (0.34%)  1
Adenocarcinoma Gastric  1/299 (0.33%)  1 0/297 (0.00%)  0
Basal Cell Carcinoma  1/299 (0.33%)  1 0/297 (0.00%)  0
Breast Cancer  1/299 (0.33%)  1 0/297 (0.00%)  0
Haemangioma Of Liver  1/299 (0.33%)  1 0/297 (0.00%)  0
Lung Cancer Metastatic  1/299 (0.33%)  1 0/297 (0.00%)  0
Melanocytic Naevus  1/299 (0.33%)  1 0/297 (0.00%)  0
Breast Fibroma  0/299 (0.00%)  0 1/297 (0.34%)  1
Invasive Ductal Breast Carcinoma  0/299 (0.00%)  0 1/297 (0.34%)  1
Neoplasm  0/299 (0.00%)  0 1/297 (0.34%)  1
Pyogenic Granuloma  0/299 (0.00%)  0 1/297 (0.34%)  1
Nervous system disorders     
Headache  13/299 (4.35%)  15 8/297 (2.69%)  16
Dizziness  2/299 (0.67%)  3 7/297 (2.36%)  7
Syncope  2/299 (0.67%)  2 1/297 (0.34%)  1
Anosmia  1/299 (0.33%)  1 0/297 (0.00%)  0
Disturbance In Attention  1/299 (0.33%)  1 0/297 (0.00%)  0
Dystonia  1/299 (0.33%)  1 0/297 (0.00%)  0
Hypoaesthesia  1/299 (0.33%)  2 1/297 (0.34%)  1
Migraine  1/299 (0.33%)  1 0/297 (0.00%)  0
Parosmia  1/299 (0.33%)  1 0/297 (0.00%)  0
Radiculopathy  1/299 (0.33%)  1 0/297 (0.00%)  0
Sciatica  1/299 (0.33%)  1 2/297 (0.67%)  3
Stupor  1/299 (0.33%)  1 0/297 (0.00%)  0
Aphasia  0/299 (0.00%)  0 1/297 (0.34%)  1
Balance Disorder  0/299 (0.00%)  0 1/297 (0.34%)  1
Hypertensive Encephalopathy  0/299 (0.00%)  0 1/297 (0.34%)  1
Loss Of Consciousness  0/299 (0.00%)  0 1/297 (0.34%)  1
Lumbar Radiculopathy  0/299 (0.00%)  0 1/297 (0.34%)  1
Paraesthesia  0/299 (0.00%)  0 1/297 (0.34%)  1
Somnolence  0/299 (0.00%)  0 2/297 (0.67%)  2
Tremor  0/299 (0.00%)  0 1/297 (0.34%)  1
Psychiatric disorders     
Insomnia  2/299 (0.67%)  2 1/297 (0.34%)  1
Sleep Disorder  2/299 (0.67%)  2 0/297 (0.00%)  0
Anxiety  1/299 (0.33%)  1 0/297 (0.00%)  0
Anxiety Disorder  1/299 (0.33%)  1 0/297 (0.00%)  0
Initial Insomnia  1/299 (0.33%)  1 0/297 (0.00%)  0
Tachyphrenia  1/299 (0.33%)  1 0/297 (0.00%)  0
Neurosis  0/299 (0.00%)  0 1/297 (0.34%)  1
Renal and urinary disorders     
Haematuria  2/299 (0.67%)  3 2/297 (0.67%)  3
Calculus Bladder  1/299 (0.33%)  1 0/297 (0.00%)  0
Renal Cyst  1/299 (0.33%)  1 0/297 (0.00%)  0
Urinary Tract Inflammation  1/299 (0.33%)  1 0/297 (0.00%)  0
Reproductive system and breast disorders     
Amenorrhoea  1/299 (0.33%)  1 0/297 (0.00%)  0
Breast Mass  1/299 (0.33%)  1 0/297 (0.00%)  0
Breast Pain  1/299 (0.33%)  1 0/297 (0.00%)  0
Breast Swelling  1/299 (0.33%)  1 0/297 (0.00%)  0
Cervical Polyp  1/299 (0.33%)  1 0/297 (0.00%)  0
Dysmenorrhoea  1/299 (0.33%)  1 0/297 (0.00%)  0
Ovarian Cyst  1/299 (0.33%)  1 0/297 (0.00%)  0
Uterine Polyp  1/299 (0.33%)  1 0/297 (0.00%)  0
Vaginal Prolapse  1/299 (0.33%)  1 0/297 (0.00%)  0
Vulvovaginal Pruritus  1/299 (0.33%)  1 0/297 (0.00%)  0
Breast Induration  0/299 (0.00%)  0 1/297 (0.34%)  1
Menopausal Symptoms  0/299 (0.00%)  0 1/297 (0.34%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  4/299 (1.34%)  4 10/297 (3.37%)  11
Oropharyngeal Pain  4/299 (1.34%)  5 1/297 (0.34%)  1
Upper Respiratory Tract Inflammation  2/299 (0.67%)  2 1/297 (0.34%)  1
Chronic Obstructive Pulmonary Disease  1/299 (0.33%)  1 0/297 (0.00%)  0
Nasal Congestion  1/299 (0.33%)  1 0/297 (0.00%)  0
Productive Cough  1/299 (0.33%)  1 0/297 (0.00%)  0
Rhinitis Allergic  1/299 (0.33%)  1 0/297 (0.00%)  0
Rhinorrhoea  1/299 (0.33%)  1 0/297 (0.00%)  0
Sneezing  1/299 (0.33%)  1 0/297 (0.00%)  0
Tonsillar Hypertrophy  1/299 (0.33%)  1 0/297 (0.00%)  0
Asthma  0/299 (0.00%)  0 2/297 (0.67%)  2
Dyspnoea  0/299 (0.00%)  0 1/297 (0.34%)  1
Nasal Inflammation  0/299 (0.00%)  0 1/297 (0.34%)  1
Rhinitis Atrophic  0/299 (0.00%)  0 1/297 (0.34%)  1
Skin and subcutaneous tissue disorders     
Rash  6/299 (2.01%)  6 4/297 (1.35%)  4
Dry Skin  3/299 (1.00%)  3 1/297 (0.34%)  1
Rash Papular  3/299 (1.00%)  4 1/297 (0.34%)  2
Alopecia  2/299 (0.67%)  2 3/297 (1.01%)  4
Erythema  2/299 (0.67%)  4 10/297 (3.37%)  10
Hyperhidrosis  2/299 (0.67%)  2 3/297 (1.01%)  3
Pruritus  2/299 (0.67%)  2 4/297 (1.35%)  4
Urticaria  2/299 (0.67%)  2 0/297 (0.00%)  0
Acne  1/299 (0.33%)  1 0/297 (0.00%)  0
Dermatitis Allergic  1/299 (0.33%)  1 0/297 (0.00%)  0
Erythema Annulare  1/299 (0.33%)  1 0/297 (0.00%)  0
Onychoclasis  1/299 (0.33%)  1 0/297 (0.00%)  0
Psoriasis  1/299 (0.33%)  1 1/297 (0.34%)  1
Rash Pruritic  1/299 (0.33%)  1 0/297 (0.00%)  0
Rosacea  1/299 (0.33%)  2 0/297 (0.00%)  0
Skin Mass  1/299 (0.33%)  1 0/297 (0.00%)  0
Dermatitis  0/299 (0.00%)  0 1/297 (0.34%)  1
Dermatitis Contact  0/299 (0.00%)  0 1/297 (0.34%)  1
Prurigo  0/299 (0.00%)  0 1/297 (0.34%)  1
Umbilical Erythema  0/299 (0.00%)  0 1/297 (0.34%)  1
Social circumstances     
Menopause  0/299 (0.00%)  0 1/297 (0.34%)  1
Surgical and medical procedures     
Tooth Extraction  0/299 (0.00%)  0 2/297 (0.67%)  2
Vascular disorders     
Hypertension  11/299 (3.68%)  16 11/297 (3.70%)  12
Hypotension  2/299 (0.67%)  2 0/297 (0.00%)  0
Hypertensive Crisis  1/299 (0.33%)  1 1/297 (0.34%)  1
Vasculitis  1/299 (0.33%)  1 0/297 (0.00%)  0
Pallor  0/299 (0.00%)  0 1/297 (0.34%)  1
1
Term from vocabulary, MedDRA 16.0
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. If the Sponsor requests, the Site shall remove any Confidential Information (other than Study results) prior to submitting or presenting the materials.
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: NCT01895309     History of Changes
Other Study ID Numbers: SB4-G31-RA
First Submitted: July 3, 2013
First Posted: July 10, 2013
Results First Submitted: July 13, 2016
Results First Posted: August 29, 2016
Last Update Posted: August 17, 2017