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To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis (SARIL-RA-EASY)

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ClinicalTrials.gov Identifier: NCT02057250
Recruitment Status : Completed
First Posted : February 7, 2014
Results First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition RA
Interventions Drug: Sarilumab
Device: Auto-Injector Device (AID)
Device: Pre-filled Syringe (PFS)
Drug: Methotrexate
Drug: Sulfasalazine
Drug: Leflunomide
Drug: Hydroxychloroquine
Enrollment 217
Recruitment Details The study was conducted at 53 centers in 6 countries. A total of 419 participants were screened between 18 March 2014 and 14 October 2014, out of which 217 participants were enrolled and treated.
Pre-assignment Details Participants were randomized in 1:1:1:1 ratio to Sarilumab 150 mg administered by auto-injector device (AID) or prefilled syringe (PFS) or Sarilumab 200 mg administered by AID or PFS. Participants who completed 12-week AID assessment phase, were treated in open-label extension phase for 52 weeks.
Arm/Group Title Sarilumab 150 mg by AID (AID Assessment Phase) Sarilumab 150 mg by PFS (AID Assessment Phase) Sarilumab 200 mg by AID (AID Assessment Phase) Sarilumab 200 mg by PFS (AID Assessment Phase) Sarilumab 150 mg by PFS (Extension Phase)
Hide Arm/Group Description Sarilumab 150 mg subcutaneous (SC) injection every 2 weeks (q2w) administered by AID with one or a combination of non-biologic disease-modifying anti-rheumatic drug (DMARD) for 12 weeks. Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks. Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks. Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks. Participants who completed 12 week AID assessment phase received Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
Period Title: AID Assessment Phase
Started 56 53 52 56 0
Completed 52 50 45 54 0
Not Completed 4 3 7 2 0
Reason Not Completed
Adverse Event             3             2             6             1             0
Other than specified above             1             1             1             1             0
Period Title: Extension Phase
Started 0 0 0 0 192 [1]
Treated 0 0 0 0 188
Completed 0 0 0 0 156
Not Completed 0 0 0 0 36
Reason Not Completed
Adverse Event             0             0             0             0             15
Lack of Efficacy             0             0             0             0             10
Entered in this period but not treated             0             0             0             0             4
Other than specified above             0             0             0             0             7
[1]
9 participants who completed AID Assessment phase did not enter extension phase.
Arm/Group Title Sarilumab 150 mg by AID (AID Assessment Phase) Sarilumab 150 mg by PFS (AID Assessment Phase) Sarilumab 200 mg by AID (AID Assessment Phase) Sarilumab 200 mg by PFS (AID Assessment Phase) Total
Hide Arm/Group Description Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks. Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks. Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks. Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 56 53 52 56 217
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 53 participants 52 participants 56 participants 217 participants
53.7  (13.8) 54.2  (14.2) 55.9  (12.3) 50.3  (12.8) 53.5  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 53 participants 52 participants 56 participants 217 participants
Female
45
  80.4%
43
  81.1%
44
  84.6%
49
  87.5%
181
  83.4%
Male
11
  19.6%
10
  18.9%
8
  15.4%
7
  12.5%
36
  16.6%
1.Primary Outcome
Title Number of Validated AID Associated Product Technical Failures (PTFs)
Hide Description A PTF was defined as any product technical complaint (PTC) related to the use of the AID that had a validated technical cause. Each participant was given a diary having questions related to participant's ability to remove the cap, to start the injection, to complete the injection and regarding confirmation of completing the injection. Participants were asked to answer the questions each time they self-inject the sarilumab. If the response was "no" to any of the first 3 questions, this was considered as a PTC. The used AID, for which PTC was reported, was sent to sponsor, examined and evaluated for the occurrence of a PTF.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of investigational medicinal product (IMP) with AID and attended at least 1 post-baseline visit during AID assessment phase of the study.
Arm/Group Title Sarilumab 150 mg by AID (AID Assessment Phase) Sarilumab 200 mg by AID (AID Assessment Phase)
Hide Arm/Group Description:
Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
Overall Number of Participants Analyzed 56 52
Overall Number of Units Analyzed
Type of Units Analyzed: Injections
312 288
Measure Type: Number
Unit of Measure: PTFs
0 0
2.Secondary Outcome
Title Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab
Hide Description AUC(0-tau) is defined as area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval, where dose interval was 2 weeks. Serum concentrations of sarilumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Time Frame Week 0-2: pre-dose on Day 1, anytime post-dose on Day 3, Day 5, Day 8, Day 12, Day 15; Week 10-12: pre-dose on Day 71, anytime post-dose on Day 73, Day 75, Day 78, Day 82, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic(PK) population included all randomized participants who received at least 1 dose of IMP and have least 1 PK parameter calculated using non compartmental methods following the first (Day 1) or sixth administration (Day 71). Here, Number Analyzed = participants with available data for specified category for each arm, respectively.
Arm/Group Title Sarilumab 150 mg by AID (AID Assessment Phase) Sarilumab 150 mg by PFS (AID Assessment Phase) Sarilumab 200 mg by AID (AID Assessment Phase) Sarilumab 200 mg by PFS (AID Assessment Phase)
Hide Arm/Group Description:
Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
Overall Number of Participants Analyzed 56 53 52 56
Mean (Standard Deviation)
Unit of Measure: mg*day/L
Week 0-2 Number Analyzed 39 participants 34 participants 34 participants 41 participants
131  (54.5) 152  (76.7) 235  (117) 227  (94.9)
Week 10-12 Number Analyzed 44 participants 40 participants 36 participants 38 participants
205  (126) 220  (130) 455  (294) 405  (244)
Time Frame All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (74 Weeks) regardless of seriousness or relationship to study drug.
Adverse Event Reporting Description Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (time from first dose of IMP in AID assessment phase up to last dose of IMP in extension phase + 6 weeks). Safety population of AID assessment phase included all randomized participants who received at least 1 dose or part of a dose of IMP and safety population of extension phase included all participants who continued in the extension phase and received at least 1 dose or part of a dose of IMP.
 
Arm/Group Title Sarilumab 150 mg by AID (AID Assessment Phase) Sarilumab 150 mg by PFS (AID Assessment Phase) Sarilumab 200 mg by AID (AID Assessment Phase) Sarilumab 200 mg by PFS (AID Assessment Phase) Sarilumab 150 mg by PFS (Extension Phase)
Hide Arm/Group Description Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks. Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks. Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks. Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks. Participants who completed 12 week AID assessment phase received Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
All-Cause Mortality
Sarilumab 150 mg by AID (AID Assessment Phase) Sarilumab 150 mg by PFS (AID Assessment Phase) Sarilumab 200 mg by AID (AID Assessment Phase) Sarilumab 200 mg by PFS (AID Assessment Phase) Sarilumab 150 mg by PFS (Extension Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Sarilumab 150 mg by AID (AID Assessment Phase) Sarilumab 150 mg by PFS (AID Assessment Phase) Sarilumab 200 mg by AID (AID Assessment Phase) Sarilumab 200 mg by PFS (AID Assessment Phase) Sarilumab 150 mg by PFS (Extension Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/56 (1.79%)   0/53 (0.00%)   3/52 (5.77%)   4/56 (7.14%)   19/188 (10.11%) 
Blood and lymphatic system disorders           
Anaemia  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Cardiac disorders           
Coronary artery occlusion  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Wolff-Parkinson-White syndrome  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Eye disorders           
Cataract  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Gastrointestinal disorders           
Small intestinal obstruction  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Vomiting  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Hepatobiliary disorders           
Bile duct stone  1  0/56 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  0/56 (0.00%)  0/188 (0.00%) 
Cholelithiasis  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  1/56 (1.79%)  0/188 (0.00%) 
Infections and infestations           
Bursitis infective staphylococcal  1  1/56 (1.79%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  0/188 (0.00%) 
Cellulitis  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  1/56 (1.79%)  0/188 (0.00%) 
Erysipelas  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  1/56 (1.79%)  0/188 (0.00%) 
Pneumonia  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Urinary tract infection  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Injury, poisoning and procedural complications           
Femoral neck fracture  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Traumatic arthritis  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Lumbar spinal stenosis  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Osteoarthritis  1  0/56 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  0/56 (0.00%)  1/188 (0.53%) 
Rheumatoid arthritis  1  0/56 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  0/56 (0.00%)  0/188 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Pancreatic carcinoma metastatic  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Squamous cell carcinoma of skin  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  1/56 (1.79%)  0/188 (0.00%) 
Nervous system disorders           
Transient ischaemic attack  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Vertebrobasilar insufficiency  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Renal and urinary disorders           
Nephrolithiasis  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Reproductive system and breast disorders           
Endometrial hyperplasia  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Rheumatoid lung  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Vascular disorders           
Deep vein thrombosis  1  0/56 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  0/56 (0.00%)  0/188 (0.00%) 
Thrombophlebitis superficial  1  0/56 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sarilumab 150 mg by AID (AID Assessment Phase) Sarilumab 150 mg by PFS (AID Assessment Phase) Sarilumab 200 mg by AID (AID Assessment Phase) Sarilumab 200 mg by PFS (AID Assessment Phase) Sarilumab 150 mg by PFS (Extension Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   29/56 (51.79%)   21/53 (39.62%)   24/52 (46.15%)   23/56 (41.07%)   83/188 (44.15%) 
Blood and lymphatic system disorders           
Leukopenia  1  3/56 (5.36%)  2/53 (3.77%)  0/52 (0.00%)  0/56 (0.00%)  1/188 (0.53%) 
Neutropenia  1  10/56 (17.86%)  9/53 (16.98%)  6/52 (11.54%)  4/56 (7.14%)  12/188 (6.38%) 
Thrombocytopenia  1  4/56 (7.14%)  1/53 (1.89%)  2/52 (3.85%)  1/56 (1.79%)  3/188 (1.60%) 
Gastrointestinal disorders           
Nausea  1  1/56 (1.79%)  0/53 (0.00%)  0/52 (0.00%)  3/56 (5.36%)  0/188 (0.00%) 
General disorders           
Injection site erythema  1  2/56 (3.57%)  2/53 (3.77%)  4/52 (7.69%)  4/56 (7.14%)  7/188 (3.72%) 
Injection site pruritus  1  1/56 (1.79%)  2/53 (3.77%)  0/52 (0.00%)  4/56 (7.14%)  5/188 (2.66%) 
Infections and infestations           
Bronchitis  1  4/56 (7.14%)  1/53 (1.89%)  1/52 (1.92%)  1/56 (1.79%)  8/188 (4.26%) 
Nasopharyngitis  1  4/56 (7.14%)  1/53 (1.89%)  1/52 (1.92%)  2/56 (3.57%)  4/188 (2.13%) 
Pharyngitis  1  5/56 (8.93%)  0/53 (0.00%)  1/52 (1.92%)  1/56 (1.79%)  2/188 (1.06%) 
Sinusitis  1  1/56 (1.79%)  3/53 (5.66%)  0/52 (0.00%)  1/56 (1.79%)  12/188 (6.38%) 
Upper respiratory tract infection  1  3/56 (5.36%)  2/53 (3.77%)  1/52 (1.92%)  3/56 (5.36%)  25/188 (13.30%) 
Urinary tract infection  1  2/56 (3.57%)  2/53 (3.77%)  2/52 (3.85%)  2/56 (3.57%)  10/188 (5.32%) 
Injury, poisoning and procedural complications           
Accidental overdose  1  0/56 (0.00%)  0/53 (0.00%)  2/52 (3.85%)  3/56 (5.36%)  8/188 (4.26%) 
Contusion  1  3/56 (5.36%)  0/53 (0.00%)  0/52 (0.00%)  0/56 (0.00%)  3/188 (1.60%) 
Investigations           
Alanine aminotransferase increased  1  1/56 (1.79%)  1/53 (1.89%)  5/52 (9.62%)  1/56 (1.79%)  9/188 (4.79%) 
Vascular disorders           
Hypertension  1  2/56 (3.57%)  1/53 (1.89%)  3/52 (5.77%)  2/56 (3.57%)  1/188 (0.53%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 18.1
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
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02057250    
Other Study ID Numbers: MSC12665
2012-004339-21
U1111-1130-9931 ( Other Identifier: UTN )
First Submitted: January 31, 2014
First Posted: February 7, 2014
Results First Submitted: May 23, 2017
Results First Posted: June 20, 2017
Last Update Posted: June 20, 2017