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Trial record 1 of 1 for:    SARIL-RA-ASCERTAIN
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To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

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ClinicalTrials.gov Identifier: NCT01768572
Recruitment Status : Completed
First Posted : January 15, 2013
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

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: sarilumab SAR153191 (REGN88)
Drug: tocilizumab
Drug: hydroxychloroquine
Drug: methotrexate
Drug: sulfasalazine
Drug: leflunomide
Drug: subcutaneous placebo
Drug: intravenous placebo
Enrollment 202
Recruitment Details The study was conducted at 78 centers in 19 countries. A total of 389 participants were screened between 25 March 2013 and 02 April 2014, 187 of whom were screen failures. Screen failures were mainly due to failure to meet inclusion and exclusion criteria.
Pre-assignment Details Randomization of participants were stratified by region and screening value of absolute neutrophil count. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in 1:1:2 (sarilumab 150 mg q2w: sarilumab 200 mg q2w: tocilizumab q4w). 202 participants were randomized.
Arm/Group Title Sarilumab 150 mg q2w Sarilumab 200 mg q2w Tocilizumab q4w
Hide Arm/Group Description Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD) for 24 weeks. Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator's discretion.
Period Title: Overall Study
Started 49 51 102
Completed 40 39 96
Not Completed 9 12 6
Reason Not Completed
Adverse Event             7             8             4
Lack of Efficacy             1             3             1
Other, Not due to an adverse event             1             1             1
Arm/Group Title Sarilumab 150 mg q2w Sarilumab 200 mg q2w Tocilizumab q4w Total
Hide Arm/Group Description Sarilumab 150 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator's discretion. Total of all reporting groups
Overall Number of Baseline Participants 49 51 102 202
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 51 participants 102 participants 202 participants
54.8  (12.1) 51.7  (13.1) 50.4  (13.0) 51.8  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 51 participants 102 participants 202 participants
Female
41
  83.7%
39
  76.5%
82
  80.4%
162
  80.2%
Male
8
  16.3%
12
  23.5%
20
  19.6%
40
  19.8%
Duration of rheumatoid arthritis (RA) since diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 51 participants 102 participants 202 participants
13.59  (8.24) 10.45  (7.57) 10.84  (8.91) 11.41  (8.48)
RA functional class   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants 51 participants 102 participants 202 participants
I 10 4 16 30
II 25 33 62 120
III 14 14 24 52
IV 0 0 0 0
[1]
Measure Description: RA Class I participants: completely able to perform usual activities of daily living (self-care, vocational and avocational); Class II participants: able to perform usual self-care and vocational activities, but limited in avocational activities; Class III participants: able to perform usual self-care activities, but limited in vocational and avocational activities; Class IV participants: limited in ability to perform usual self-care, vocational and avocational activities.
Health Assessment Questionnaire Disability Index (HAQ-DI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 49 participants 51 participants 102 participants 202 participants
1.63  (0.66) 1.71  (0.60) 1.78  (0.63) 1.72  (0.63)
[1]
Measure Description: Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: HAQ-DI is consisted of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; activities are rated on a 4-point scale where 0=best and 3=worst. Overall score was computed as the sum of domain scores and divided by the number of domains answered, ranging from 0 to 3, where 0 = no disability and 3 = very severe, high-dependency disability.
Disease Activity Score for 28 Joints- C-reactive protein (DAS28-CRP)   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on scale
Number Analyzed 49 participants 51 participants 102 participants 202 participants
5.85  (0.92) 5.88  (0.97) 5.91  (1.01) 5.89  (0.97)
[1]
Measure Description: The DAS28-CRP is a composite score that contains 4 variables: Tender Joints Count (based on 28 joints), Swollen Joints Count (based on 28 joints), general health assessment and high sensitivity C-reactive protein (hs-CRP) in mg/L or erythrocyte sedimentation rate (ESR) in mm/hr. It ranges from 0-10 with a lower score indicating less disease activity. A DAS28-CRP above 5.1 indicates high disease activity, whereas a below 3.2 indicates low disease activity and below 2.6 as disease remission.
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Hide Description Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. All adverse events that occurred from the first dose of the study drug administration up to 60 days after the end of treatment visit were considered as TEAEs. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. A summary of SAEs, all other non-serious AEs, regardless of causality, are reported in AE section.
Time Frame Up to 211 days
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all randomized participants who received at least 1 dose or a partial dose of study drug analyzed according to the treatment actually received.
Arm/Group Title Sarilumab 150 mg q2w Sarilumab 200 mg q2w Tocilizumab q4w
Hide Arm/Group Description:
Sarilumab 150 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator's discretion.
Overall Number of Participants Analyzed 49 51 102
Measure Type: Number
Unit of Measure: participants
Any TEAE 33 36 68
Any treatment-emergent SAE 1 3 7
Any TEAE leading to death 0 0 1
Any TEAE leading to discontinuation 6 8 4
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.
 
Arm/Group Title Sarilumab 150 mg q2w Sarilumab 200 mg q2w Tocilizumab q4w
Hide Arm/Group Description Sarilumab 150 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator's discretion.
All-Cause Mortality
Sarilumab 150 mg q2w Sarilumab 200 mg q2w Tocilizumab q4w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Sarilumab 150 mg q2w Sarilumab 200 mg q2w Tocilizumab q4w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/49 (2.04%)   3/51 (5.88%)   7/102 (6.86%) 
Blood and lymphatic system disorders       
Neutropenia  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Cardiac disorders       
Atrial fibrillation  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Infections and infestations       
Erysipelas  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Septic shock  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Urinary tract infection  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Investigations       
Transaminases increased  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Musculoskeletal and connective tissue disorders       
Osteochondrosis  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Pseudarthrosis  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Nervous system disorders       
Tremor  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Renal and urinary disorders       
Renal failure acute  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Respiratory, thoracic and mediastinal disorders       
Idiopathic pulmonary fibrosis  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Pulmonary embolism  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Vascular disorders       
Deep vein thrombosis  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sarilumab 150 mg q2w Sarilumab 200 mg q2w Tocilizumab q4w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   33/49 (67.35%)   36/51 (70.59%)   66/102 (64.71%) 
Blood and lymphatic system disorders       
Anaemia of chronic disease  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Iron deficiency anaemia  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Leukocytosis  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Leukopenia  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Lymphadenopathy  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Lymphopenia  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Neutropenia  1  6/49 (12.24%)  8/51 (15.69%)  3/102 (2.94%) 
Neutrophilia  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Normochromic normocytic anaemia  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Thrombocytopenia  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Cardiac disorders       
Cardiac failure chronic  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Ear and labyrinth disorders       
Vertigo  1  1/49 (2.04%)  1/51 (1.96%)  0/102 (0.00%) 
Eye disorders       
Dark circles under eyes  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Ocular hyperaemia  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Ulcerative keratitis  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Abdominal pain upper  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Diarrhoea  1  2/49 (4.08%)  0/51 (0.00%)  1/102 (0.98%) 
Dyspepsia  1  0/49 (0.00%)  2/51 (3.92%)  0/102 (0.00%) 
Gastric ulcer  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Gastritis  1  1/49 (2.04%)  1/51 (1.96%)  0/102 (0.00%) 
Gastrointestinal disorder  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Gastrooesophageal reflux disease  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Haematochezia  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Irritable bowel syndrome  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Loose tooth  1  0/49 (0.00%)  1/51 (1.96%)  1/102 (0.98%) 
Mouth ulceration  1  0/49 (0.00%)  2/51 (3.92%)  3/102 (2.94%) 
Nausea  1  1/49 (2.04%)  1/51 (1.96%)  7/102 (6.86%) 
Stomatitis  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Vomiting  1  0/49 (0.00%)  2/51 (3.92%)  0/102 (0.00%) 
General disorders       
Chills  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Device dislocation  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Fatigue  1  1/49 (2.04%)  0/51 (0.00%)  1/102 (0.98%) 
Injection site erythema  1  4/49 (8.16%)  4/51 (7.84%)  1/102 (0.98%) 
Injection site macule  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Injection site nodule  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Injection site pain  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Injection site papule  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Injection site pruritus  1  2/49 (4.08%)  1/51 (1.96%)  1/102 (0.98%) 
Injection site rash  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Malaise  1  1/49 (2.04%)  0/51 (0.00%)  2/102 (1.96%) 
Nodule  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Non-cardiac chest pain  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Pain  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Hepatobiliary disorders       
Hypertransaminasaemia  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Immune system disorders       
Seasonal allergy  1  0/49 (0.00%)  0/51 (0.00%)  2/102 (1.96%) 
Infections and infestations       
Acute sinusitis  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Bronchitis  1  1/49 (2.04%)  0/51 (0.00%)  1/102 (0.98%) 
Bronchitis viral  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Cellulitis  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Conjunctivitis  1  2/49 (4.08%)  0/51 (0.00%)  0/102 (0.00%) 
Cystitis  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Gastroenteritis  1  3/49 (6.12%)  0/51 (0.00%)  1/102 (0.98%) 
Herpes simplex  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Influenza  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Lower respiratory tract infection  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Nasopharyngitis  1  6/49 (12.24%)  3/51 (5.88%)  4/102 (3.92%) 
Onychomycosis  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Oral herpes  1  2/49 (4.08%)  0/51 (0.00%)  2/102 (1.96%) 
Otitis media  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Paronychia  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Periodontitis  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Pharyngotonsillitis  1  1/49 (2.04%)  1/51 (1.96%)  1/102 (0.98%) 
Pneumonia  1  2/49 (4.08%)  0/51 (0.00%)  0/102 (0.00%) 
Pyuria  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Rhinitis  1  1/49 (2.04%)  0/51 (0.00%)  1/102 (0.98%) 
Sinusitis  1  0/49 (0.00%)  0/51 (0.00%)  2/102 (1.96%) 
Skin infection  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Tinea pedis  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Tinea versicolour  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Tooth infection  1  1/49 (2.04%)  0/51 (0.00%)  1/102 (0.98%) 
Tracheitis  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Upper respiratory tract infection  1  2/49 (4.08%)  1/51 (1.96%)  7/102 (6.86%) 
Urinary tract infection  1  4/49 (8.16%)  1/51 (1.96%)  6/102 (5.88%) 
Viral upper respiratory tract infection  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Vulvovaginitis trichomonal  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Injury, poisoning and procedural complications       
Accidental overdose  1  1/49 (2.04%)  3/51 (5.88%)  9/102 (8.82%) 
Ankle fracture  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Contusion  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Fall  1  1/49 (2.04%)  1/51 (1.96%)  2/102 (1.96%) 
Infusion related reaction  1  0/49 (0.00%)  1/51 (1.96%)  1/102 (0.98%) 
Joint injury  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Muscle strain  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Overdose  1  1/49 (2.04%)  0/51 (0.00%)  1/102 (0.98%) 
Post-traumatic pain  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Road traffic accident  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Traumatic haematoma  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Investigations       
Alanine aminotransferase increased  1  1/49 (2.04%)  2/51 (3.92%)  5/102 (4.90%) 
Blood cholesterol increased  1  0/49 (0.00%)  1/51 (1.96%)  1/102 (0.98%) 
Blood pressure increased  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Glomerular filtration rate increased  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Liver function test abnormal  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Neutrophil count decreased  1  0/49 (0.00%)  1/51 (1.96%)  3/102 (2.94%) 
Neutrophil count increased  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Transaminases increased  1  1/49 (2.04%)  0/51 (0.00%)  1/102 (0.98%) 
Metabolism and nutrition disorders       
Dyslipidaemia  1  0/49 (0.00%)  1/51 (1.96%)  4/102 (3.92%) 
Food craving  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Hypercholesterolaemia  1  2/49 (4.08%)  1/51 (1.96%)  6/102 (5.88%) 
Hypertriglyceridaemia  1  0/49 (0.00%)  0/51 (0.00%)  2/102 (1.96%) 
Hypoglycaemia  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Hypokalaemia  1  0/49 (0.00%)  1/51 (1.96%)  1/102 (0.98%) 
Vitamin D deficiency  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Back pain  1  0/49 (0.00%)  2/51 (3.92%)  3/102 (2.94%) 
Hand deformity  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Muscle haemorrhage  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Muscle spasms  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Musculoskeletal chest pain  1  1/49 (2.04%)  0/51 (0.00%)  1/102 (0.98%) 
Myalgia  1  0/49 (0.00%)  0/51 (0.00%)  2/102 (1.96%) 
Osteoarthritis  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Pain in extremity  1  0/49 (0.00%)  0/51 (0.00%)  2/102 (1.96%) 
Rheumatoid arthritis  1  1/49 (2.04%)  0/51 (0.00%)  6/102 (5.88%) 
Rheumatoid nodule  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Spinal osteoarthritis  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Spinal pain  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Synovial cyst  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Nervous system disorders       
Carpal tunnel syndrome  1  0/49 (0.00%)  1/51 (1.96%)  1/102 (0.98%) 
Cerebral ischaemia  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Dizziness  1  1/49 (2.04%)  3/51 (5.88%)  4/102 (3.92%) 
Dysgeusia  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Headache  1  1/49 (2.04%)  0/51 (0.00%)  5/102 (4.90%) 
Hypoaesthesia  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Paraesthesia  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Sciatica  1  1/49 (2.04%)  0/51 (0.00%)  1/102 (0.98%) 
Renal and urinary disorders       
Calculus urinary  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Haematuria  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Hydronephrosis  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Reproductive system and breast disorders       
Menstruation irregular  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Ovarian cyst  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Respiratory, thoracic and mediastinal disorders       
Bronchiectasis  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Cough  1  1/49 (2.04%)  0/51 (0.00%)  1/102 (0.98%) 
Dyspnoea  1  1/49 (2.04%)  0/51 (0.00%)  0/102 (0.00%) 
Nasal ulcer  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Oropharyngeal pain  1  0/49 (0.00%)  0/51 (0.00%)  3/102 (2.94%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Dermatitis allergic  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Erythema  1  1/49 (2.04%)  0/51 (0.00%)  1/102 (0.98%) 
Pruritus  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Pruritus generalised  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Rash  1  1/49 (2.04%)  0/51 (0.00%)  2/102 (1.96%) 
Rash pruritic  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Skin ulcer  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Urticaria  1  0/49 (0.00%)  0/51 (0.00%)  1/102 (0.98%) 
Vascular disorders       
Hypertension  1  0/49 (0.00%)  2/51 (3.92%)  4/102 (3.92%) 
Vascular fragility  1  0/49 (0.00%)  1/51 (1.96%)  0/102 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 17.1
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.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
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Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact-US@sanofi.com
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01768572    
Other Study ID Numbers: SFY13370
2012-003536-23
U1111-1133-7839 ( Other Identifier: UTN )
First Submitted: January 11, 2013
First Posted: January 15, 2013
Results First Submitted: May 23, 2017
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017