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A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)

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ClinicalTrials.gov Identifier: NCT02373202
Recruitment Status : Completed
First Posted : February 26, 2015
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
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
Drug: Sulfasalazine
Drug: Leflunomide
Drug: Bucillamine
Drug: Tacrolimus
Drug: Mizoribine
Enrollment 91
Recruitment Details This study was conducted at 40 centers in Japan. A total of 117 participants were screened between 23 February 2015 and 9 September 2015, 26 of whom were screen failures.
Pre-assignment Details A total of 91 participants were randomized to receive monotherapy stratum (in a ratio of 1:1 to sarilumab 150 mg, once in every two weeks [q2w] or sarilumab 200 mg, q2w) or combination stratum (background non-methotrexate disease modifying anti-rheumatic drugs [Non-MTX DMARDs] along with sarilumab 150/ 200 mg q2w in 1:1 ratio).
Arm/Group Title Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description Participants received sarilumab 150 mg, subcutaneous (SC) injection, q2w along with non-MTX DMARDs for up to 52 weeks. Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks. Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks. Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
Period Title: Overall Study
Started 15 15 30 31
Completed 13 9 27 30
Not Completed 2 6 3 1
Reason Not Completed
Adverse Event             2             5             2             1
Lack of Efficacy             0             0             1             0
Not specified             0             1             0             0
Arm/Group Title Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Sarilumab 200 mg q2w Total
Hide Arm/Group Description Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks. Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks. Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks. Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks. Total of all reporting groups
Overall Number of Baseline Participants 15 15 30 31 91
Hide Baseline Analysis Population Description
Modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of investigational medicinal product (IMP), irrespective of compliance with the study protocol and procedures.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants 31 participants 91 participants
56.3  (10.9) 63.3  (10.6) 54.4  (13.8) 52.5  (10.3) 55.6  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants 31 participants 91 participants
Female
12
  80.0%
13
  86.7%
27
  90.0%
26
  83.9%
78
  85.7%
Male
3
  20.0%
2
  13.3%
3
  10.0%
5
  16.1%
13
  14.3%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description Adverse event (AE) was defined as any untoward medical occurrence in a participant who received IMP and did not necessary have to had a causal relationship with treatment. All AEs that occurred from the first dose of the IMP administration up to 6 weeks after last dose of treatment (up to Week 58) were considered as TEAEs. SAEs were AEs 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. TEAEs included both SAEs and non-SAEs.
Time Frame Baseline up to Week 58
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
Arm/Group Title Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
Overall Number of Participants Analyzed 15 15 30 31
Measure Type: Number
Unit of Measure: participants
Any TEAE 14 13 25 28
SAE 0 3 1 2
2.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
Hide Description

Criteria for potentially clinically significant vital sign abnormalities:

  • Systolic blood pressure (SBP) supine: <=95 mmHg and decrease from baseline (DFB) >=20 mmHg; >=160 mmHg and increase from baseline (IFB) >=20 mmHg
  • Diastolic blood pressure (DBP) supine: <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB ≥10 mmHg
  • SBP (Orthostatic): <=-20 mmHg
  • DBP (Orthostatic): <=-10 mmHg
  • Heart rate (HR) supine: <=50 beats per minute (bpm) and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm
  • Weight: >=5% DFB; >=5% IFB
Time Frame Baseline up to Week 58
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
Arm/Group Title Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
Overall Number of Participants Analyzed 15 15 30 31
Measure Type: Number
Unit of Measure: participants
SBP (supine) <=95 mmHg and DFB >=20 mmHg 0 0 0 0
SBP (supine) >=160 mmHg and IFB >=20 mmHg 1 1 1 1
DBP (supine) <=45 mmHg and DFB >=10 mmHg 0 0 0 0
DBP (supine) >=110 mmHg and IFB >=10 mmHg 0 0 0 0
SBP (orthostatic) <=-20 mmHg 8 5 5 9
DBP (orthostatic) <=-10 mmHg 3 3 5 10
HR (supine) <=50 bpm and DFB >= 20 bpm 0 0 1 1
HR (supine) >=120 bpm and IFB >=20 bpm 0 0 0 0
Weight >=5% DFB 1 1 2 0
Weight >=5% IFB 3 2 12 7
3.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
Hide Description

Criteria for potentially clinically significant ECG abnormalities:

  • PR Interval: >200 milliseconds (ms); >200 ms and IFB >=25%; >220 ms; >220 ms and IFB >=25%; >240 ms; >240 ms and IFB >=25%
  • QRS Interval: >110 ms; >110 ms and IFB >=25%; >120 ms; >120 ms and IFB >=25%
  • QT Interval: >500 ms
  • QTc Bazett (QTc B): >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms, IFB >60 ms
  • QTc Fridericia (QTc F): >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms; IFB >60 ms
Time Frame Baseline up to Week 58
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
Arm/Group Title Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
Overall Number of Participants Analyzed 15 15 30 31
Measure Type: Number
Unit of Measure: participants
PR >200 ms Number Analyzed 15 participants 15 participants 30 participants 31 participants
0 0 0 1
PR >200 ms and IFB >=25% Number Analyzed 15 participants 15 participants 30 participants 30 participants
0 0 0 0
PR >220 ms Number Analyzed 15 participants 15 participants 30 participants 31 participants
0 0 0 1
PR >220 ms and IFB >=25% Number Analyzed 15 participants 15 participants 30 participants 30 participants
0 0 0 0
PR >240 ms Number Analyzed 15 participants 15 participants 30 participants 31 participants
0 0 0 0
PR >240 ms and IFB >=25% Number Analyzed 15 participants 15 participants 30 participants 30 participants
0 0 0 0
QRS >110 ms Number Analyzed 15 participants 15 participants 30 participants 31 participants
0 2 0 1
QRS >110 ms and IFB >=25% Number Analyzed 15 participants 15 participants 30 participants 30 participants
0 0 0 0
QRS >120 ms Number Analyzed 15 participants 15 participants 30 participants 31 participants
0 2 0 0
QRS >120 ms and IFB >=25% Number Analyzed 15 participants 15 participants 30 participants 30 participants
0 0 0 0
QT >500 ms Number Analyzed 15 participants 15 participants 30 participants 31 participants
0 0 0 1
QTc B >450 ms Number Analyzed 15 participants 15 participants 30 participants 31 participants
2 1 6 10
QTc B >480 ms Number Analyzed 15 participants 15 participants 30 participants 31 participants
0 1 0 1
QTc B >500 ms Number Analyzed 15 participants 15 participants 30 participants 31 participants
0 0 0 0
QTc B IFB >30 and <=60 ms Number Analyzed 15 participants 15 participants 30 participants 30 participants
0 1 2 1
QTc B IFB >60 ms Number Analyzed 15 participants 15 participants 30 participants 30 participants
0 0 0 0
QTc F >450 ms Number Analyzed 15 participants 15 participants 30 participants 31 participants
2 1 2 6
QTc F >480 ms Number Analyzed 15 participants 15 participants 30 participants 31 participants
0 0 0 1
QTc F >500 ms Number Analyzed 15 participants 15 participants 30 participants 31 participants
0 0 0 0
QTc F IFB >30 and <=60 ms Number Analyzed 15 participants 15 participants 30 participants 30 participants
0 0 0 0
QTc F IFB >60 ms Number Analyzed 15 participants 15 participants 30 participants 30 participants
0 0 0 0
4.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Hide Description

Criteria for potentially clinically significant abnormalities:

  • Hemoglobin: <=115 g/L (Male[M]) or <=95 g/L (Female[F]); >=185 g/L (M) or >=165 g/L (F); DFB >=20 g/L
  • Hematocrit: <=0.37 v/v (M) or <=0.32 v/v (F); >=0.55 v/v (M) or >=0.5 v/v (F)
  • Red blood cells (RBC): >=6 Tera/L
  • Platelets: <50 Giga/L; >=50 and <100 Giga/L; >=700 Giga/L
  • White blood cells (WBC): <3.0 Giga/L (Non-Black [NB]) or <2.0 Giga/L (Black [B]); >=16.0 Giga/L
  • Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B); <1.0 Giga/L
  • Lymphocytes: <0.5 Giga/L; >=0.5 Giga/L and <lower limit of normal (LLN); >4.0 Giga/L
  • Monocytes: >0.7 Giga/L
  • Basophils: >0.1 Giga/L
  • Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L)
Time Frame Baseline up to Week 58
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
Arm/Group Title Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
Overall Number of Participants Analyzed 15 15 30 31
Measure Type: Number
Unit of Measure: participants
Hemoglobin <=115 g/L (M) or <=95 g/L (F) 0 1 1 3
Hemoglobin >=185 g/L (M) or >=165 g/L (F) 0 0 0 0
Hemoglobin DFB >=20 g/L 0 0 0 2
Hematocrit <=0.37 v/v (M) or <=0.32 v/v (F) 0 3 2 6
Hematocrit >0.55 v/v (M) or >=0.5 v/v (F) 0 0 0 0
RBC >=6 Tera/L 0 0 0 0
Platelets <50 Giga/L 0 0 0 0
Platelets >=50 and <100 Giga/L 1 1 1 0
Platelets >=700 Giga/L 0 0 0 0
WBC <3.0 Giga/L (NB) or <2.0 Giga/L (B) 6 9 7 9
WBC >=16.0 Giga/L 0 0 0 0
Neutrophils <1.5 Giga/L (NB) or <1.0 Giga/L (B) 8 11 8 13
Neutrophils <1.0 Giga/L 5 3 2 4
Lymphocytes <0.5 Giga/L 0 0 0 1
Lymphocytes >=0.5 Giga/L and <LLN 3 4 3 8
Lymphocytes >4.0 Giga/L 0 1 0 0
Monocytes >0.7 Giga/L 1 0 3 2
Basophils >0.1 Giga/L 1 0 0 5
Eosinophils >0.5 Giga/L or >ULN (ULN >=0.5 Giga/L) 0 0 2 2
5.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters
Hide Description

Criteria for potentially clinically significant abnormalities:

  • Glucose: <=3.9 mmol/L and <LLN; >=11.1 mmol/L (unfasted [unfas]) or >=7 mmol/L (fasted [fas])
  • Hemoglobin A1c (HbA1c): >8%
  • Total cholesterol: >=6.2 mmol/L; >=7.74 mmol/L
  • LDL cholesterol: >=4.1 mmol/L; >=4.9 mmol/L
  • Triglycerides: >=4.6 mmol/L; >=5.6 mmol/L
Time Frame Baseline up to Week 58
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
Arm/Group Title Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
Overall Number of Participants Analyzed 15 15 30 31
Measure Type: Number
Unit of Measure: participants
Glucose <=3.9 mmol/L and <LLN 0 0 1 1
Glucose >=11.1 mmol/L (unfas) or >=7 mmol/L (fas) 0 1 0 2
HbA1c >8% 0 0 0 1
Total Cholesterol >=6.2 mmol/L 6 7 12 13
Total Cholesterol >=7.74 mmol/L 1 1 1 2
LDL Cholesterol >=4.1 mmol/L 1 3 6 3
LDL Cholesterol >=4.9 mmol/L 0 1 2 1
Triglycerides >=4.6 mmol/L 0 0 0 1
Triglycerides >=5.6 mmol/L 0 0 0 1
6.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes
Hide Description

Criteria for potentially clinically significant abnormalities:

  • Sodium: <=129 mmol/L; >=160 mmol/L
  • Potassium: <3 mmol/L; >=5.5 mmol/L
  • Chloride: <80 mmol/L; >115 mmol/L
Time Frame Baseline up to Week 58
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
Arm/Group Title Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
Overall Number of Participants Analyzed 15 15 30 31
Measure Type: Number
Unit of Measure: participants
Sodium <=129 mmol/L 0 0 0 0
Sodium >=160 mmol/L 0 0 0 0
Potassium <3 mmol/L 0 0 0 0
Potassium >=5.5 mmol/L 0 0 0 0
Chloride <80 mmol/L 0 0 0 0
Chloride >115 mmol/L 0 0 0 0
7.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
Hide Description

Criteria for potentially clinically significant abnormalities:

  • Creatinine: >=150 micromol/L (adults); >=30% change from baseline, >=100% change from baseline
  • Creatinine clearance: <15 mL/min; >=15 to <30 mL/min; >=30 to <60 mL/min; >=60 to <90 mL/min
  • Blood urea nitrogen: >=17 mmol/L
  • Uric acid: <120 micromol/L; >408 micromol/L
Time Frame Baseline up to Week 58
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
Arm/Group Title Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
Overall Number of Participants Analyzed 15 15 30 31
Measure Type: Number
Unit of Measure: participants
Creatinine >=150 micromol/L (Adults) 0 0 0 1
Creatinine >=30% change from baseline 3 3 6 5
Creatinine >=100% change from baseline 0 0 0 0
Creatinine Clearance <15 mL/min 0 0 0 0
Creatinine clearance >=15 to <30 mL/min 0 0 0 0
Creatinine clearance >=30 to <60 mL/min 6 6 6 5
Creatinine clearance >=60 to <90 mL/min 8 7 15 17
Blood Urea Nitrogen >=17 mmol/L 0 0 0 0
Uric acid <120 micromol/L 0 1 0 0
Uric acid >408 micromol/L 1 1 2 4
8.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
Hide Description

Criteria for potentially clinically significant abnormalities:

  • Alanine Aminotransferase (ALT): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN
  • Aspartate aminotransferase (AST): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN
  • Alkaline phosphatase: >1.5 ULN
  • Total bilirubin (TBILI): >1.5 ULN; >2 ULN
  • Conjugated bilirubin(CBILI): >1.5 ULN
  • Unconjugated bilirubin: >1.5 ULN
  • ALT >3 ULN and TBILI >2 ULN
  • CBILI >35% TBILI and TBILI >1.5 ULN
  • Albumin: <=25 g/L
Time Frame Baseline up to Week 58
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
Arm/Group Title Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
Overall Number of Participants Analyzed 15 15 30 31
Measure Type: Number
Unit of Measure: participants
ALT >1 ULN and <=1.5 ULN 3 4 7 6
ALT >1.5 ULN and <=3 ULN 2 1 3 2
ALT >3 ULN and <=5 ULN 1 0 1 4
ALT >5 ULN and <=10 ULN 1 0 0 0
ALT >10 ULN and <=20 ULN 0 0 0 0
ALT >20 ULN 0 0 0 0
AST >1 ULN and <=1.5 ULN 6 5 8 4
AST >1.5 ULN and <=3 ULN 1 0 2 3
AST >3 ULN and <=5 ULN 1 0 0 1
AST >5 ULN and <=10 ULN 0 0 0 0
AST >10 ULN and <=20 ULN 0 0 0 0
AST >20 ULN 0 0 0 0
Alkaline Phosphatase >1.5 ULN 0 0 0 0
TBILI >1.5 ULN 1 1 0 0
TBILI >2 ULN 0 0 0 0
CBILI >1.5 ULN 0 0 0 0
Unconjugated Bilirubin >1.5 ULN 0 0 0 0
ALT> 3 ULN and TBILI >2ULN 0 0 0 0
CBILI >35% TBILI and TBILI >1.5 ULN 0 0 0 0
Albumin <=25 g/L 0 0 0 0
9.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology (ACR) 20, 50 and 70 Responses at Week 52
Hide Description ACR response is a composite rating scale that includes 7 variables: tender joints count (TJC [68 joints]); swollen joints count (SJC [66 joints]); levels of an acute phase reactant (high sensitivity C-reactive protein [hs-CRP level]); participant’s assessment of pain (measured on 0 [no pain]-100 mm [worst pain] visual analog scale [VAS]); participant’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant’s assessment of physical function (measured by Health Assessment Question-Disability Index [HAQ-DI], with scoring range of 0 [better health] - 3 [worst health]). ACR20/50/70 response is defined as at least 20/50/70% improvement in both TJC and SJC, and at least 20/50/70% improvement in at least 3 of the 5 other assessments, respectively.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures.
Arm/Group Title Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
Overall Number of Participants Analyzed 15 15 30 31
Measure Type: Number
Unit of Measure: percentage of participants
ACR20 73.3 40.0 76.7 74.2
ACR50 60.0 33.3 56.7 54.8
ACR70 53.3 26.7 26.7 25.8
10.Secondary Outcome
Title Change From Baseline at Week 52 in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP)
Hide Description DAS28-CRP is a composite score that contains 4 variables: TJC (based on 28 joints), SJC (based on 28 joints), participant’s assessment of general health on VAS (range 0 [very well] to 100 mm [extremely bad]) and CRP (mg/L). DAS28-CRP total score ranges from 2-10 with a lower score indicating less disease activity. A DAS28-CRP above 5.1 indicates high disease activity, whereas below 3.2 indicates low disease activity and below 2.6 as disease remission.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures. Here ‘Overall Number of Participants Analyzed’ signifies participants evaluable for this outcome measure.
Arm/Group Title Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
Overall Number of Participants Analyzed 14 10 28 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.90  (1.06) -2.47  (0.84) -2.62  (1.12) -2.64  (1.35)
11.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52
Hide Description HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each items’s difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
Overall Number of Participants Analyzed 14 10 28 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.52  (0.45) -0.34  (0.60) -0.48  (0.58) -0.38  (0.34)
Time Frame All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Adverse Event Reporting Description Reported AEs are treatment-emergent AEs that developed/worsened during the ‘on treatment period’ (from the first IMP administration up to the 6 week after last IMP administration [up to Week 58]).
 
Arm/Group Title Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Monotherapy Sarilumab 200 mg q2w Monotherapy
Hide Arm/Group Description Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks. Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks. Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks. Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
All-Cause Mortality
Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Monotherapy Sarilumab 200 mg q2w Monotherapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/30 (0.00%)   0/31 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Monotherapy Sarilumab 200 mg q2w Monotherapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   3/15 (20.00%)   1/30 (3.33%)   2/31 (6.45%) 
Infections and infestations         
Chronic sinusitis  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Herpes zoster oticus  1  0/15 (0.00%)  0/15 (0.00%)  1/30 (3.33%)  0/31 (0.00%) 
Periorbital abscess  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Pneumonia bacterial  1  0/15 (0.00%)  0/15 (0.00%)  0/30 (0.00%)  1/31 (3.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer female  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Gastric cancer  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Surgical and medical procedures         
Abortion induced  1  0/15 (0.00%)  0/15 (0.00%)  0/30 (0.00%)  1/31 (3.23%) 
1
Term from vocabulary, MedDRA 17.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sarilumab 150 mg q2w + DMARDs Sarilumab 200 mg q2w + DMARDs Sarilumab 150 mg q2w Monotherapy Sarilumab 200 mg q2w Monotherapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/15 (93.33%)   13/15 (86.67%)   22/30 (73.33%)   23/31 (74.19%) 
Blood and lymphatic system disorders         
Neutropenia  1  5/15 (33.33%)  3/15 (20.00%)  1/30 (3.33%)  3/31 (9.68%) 
Thrombocytopenia  1  1/15 (6.67%)  1/15 (6.67%)  0/30 (0.00%)  1/31 (3.23%) 
Eye disorders         
Conjunctivitis allergic  1  0/15 (0.00%)  0/15 (0.00%)  0/30 (0.00%)  2/31 (6.45%) 
Gastrointestinal disorders         
Abdominal pain upper  1  0/15 (0.00%)  0/15 (0.00%)  0/30 (0.00%)  2/31 (6.45%) 
Constipation  1  0/15 (0.00%)  1/15 (6.67%)  1/30 (3.33%)  1/31 (3.23%) 
Gastritis  1  0/15 (0.00%)  0/15 (0.00%)  2/30 (6.67%)  0/31 (0.00%) 
Glossodynia  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Stomatitis  1  3/15 (20.00%)  4/15 (26.67%)  3/30 (10.00%)  4/31 (12.90%) 
General disorders         
Injection site erythema  1  0/15 (0.00%)  1/15 (6.67%)  1/30 (3.33%)  6/31 (19.35%) 
Injection site haemorrhage  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Injection site pruritus  1  0/15 (0.00%)  1/15 (6.67%)  1/30 (3.33%)  1/31 (3.23%) 
Injection site rash  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Injection site swelling  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  2/31 (6.45%) 
Oedema peripheral  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Hepatobiliary disorders         
Hepatic function abnormal  1  1/15 (6.67%)  0/15 (0.00%)  1/30 (3.33%)  4/31 (12.90%) 
Infections and infestations         
Bronchitis  1  0/15 (0.00%)  1/15 (6.67%)  1/30 (3.33%)  0/31 (0.00%) 
Chronic sinusitis  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Conjunctivitis  1  1/15 (6.67%)  0/15 (0.00%)  1/30 (3.33%)  0/31 (0.00%) 
Enteritis infectious  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Gastroenteritis  1  2/15 (13.33%)  0/15 (0.00%)  1/30 (3.33%)  1/31 (3.23%) 
Gingivitis  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Nasopharyngitis  1  4/15 (26.67%)  5/15 (33.33%)  13/30 (43.33%)  14/31 (45.16%) 
Periodontitis  1  0/15 (0.00%)  1/15 (6.67%)  2/30 (6.67%)  0/31 (0.00%) 
Pharyngitis  1  0/15 (0.00%)  1/15 (6.67%)  1/30 (3.33%)  0/31 (0.00%) 
Injury, poisoning and procedural complications         
Accidental overdose  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Contusion  1  3/15 (20.00%)  0/15 (0.00%)  2/30 (6.67%)  0/31 (0.00%) 
Foot fracture  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Heat stroke  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Scratch  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Investigations         
Alanine aminotransferase increased  1  1/15 (6.67%)  0/15 (0.00%)  1/30 (3.33%)  1/31 (3.23%) 
Neutrophil count decreased  1  1/15 (6.67%)  1/15 (6.67%)  2/30 (6.67%)  1/31 (3.23%) 
Protein urine  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Weight increased  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
White blood cell count decreased  1  1/15 (6.67%)  1/15 (6.67%)  0/30 (0.00%)  1/31 (3.23%) 
Metabolism and nutrition disorders         
Hypercholesterolaemia  1  0/15 (0.00%)  0/15 (0.00%)  1/30 (3.33%)  2/31 (6.45%) 
Hyperlipidaemia  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle spasms  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Musculoskeletal stiffness  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Myalgia  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Neck pain  1  1/15 (6.67%)  0/15 (0.00%)  1/30 (3.33%)  0/31 (0.00%) 
Osteoarthritis  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Osteoporosis  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Rheumatoid arthritis  1  1/15 (6.67%)  0/15 (0.00%)  4/30 (13.33%)  2/31 (6.45%) 
Synovitis  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer female  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Gastric cancer  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Nervous system disorders         
Dizziness  1  0/15 (0.00%)  2/15 (13.33%)  2/30 (6.67%)  1/31 (3.23%) 
Dysarthria  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Sciatica  1  1/15 (6.67%)  0/15 (0.00%)  1/30 (3.33%)  0/31 (0.00%) 
Psychiatric disorders         
Insomnia  1  1/15 (6.67%)  1/15 (6.67%)  0/30 (0.00%)  1/31 (3.23%) 
Renal and urinary disorders         
Haematuria  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Renal impairment  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  0/15 (0.00%)  1/15 (6.67%)  1/30 (3.33%)  0/31 (0.00%) 
Cough  1  0/15 (0.00%)  1/15 (6.67%)  1/30 (3.33%)  1/31 (3.23%) 
Epistaxis  1  0/15 (0.00%)  0/15 (0.00%)  2/30 (6.67%)  0/31 (0.00%) 
Oropharyngeal pain  1  0/15 (0.00%)  0/15 (0.00%)  3/30 (10.00%)  2/31 (6.45%) 
Rhinitis allergic  1  0/15 (0.00%)  0/15 (0.00%)  0/30 (0.00%)  2/31 (6.45%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Dermatitis contact  1  0/15 (0.00%)  0/15 (0.00%)  2/30 (6.67%)  1/31 (3.23%) 
Eczema  1  0/15 (0.00%)  1/15 (6.67%)  1/30 (3.33%)  2/31 (6.45%) 
Eczema nummular  1  1/15 (6.67%)  0/15 (0.00%)  1/30 (3.33%)  0/31 (0.00%) 
Haemorrhage subcutaneous  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  1/31 (3.23%) 
Onycholysis  1  1/15 (6.67%)  0/15 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Pruritus  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Psoriasis  1  0/15 (0.00%)  1/15 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Rash  1  1/15 (6.67%)  1/15 (6.67%)  1/30 (3.33%)  0/31 (0.00%) 
Vascular disorders         
Hypertension  1  0/15 (0.00%)  1/15 (6.67%)  1/30 (3.33%)  1/31 (3.23%) 
1
Term from vocabulary, MedDRA 17.1
Indicates events were collected by systematic assessment
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
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02373202     History of Changes
Other Study ID Numbers: LTS13618
U1111-1160-6525 ( Other Identifier: UTN )
First Submitted: February 12, 2015
First Posted: February 26, 2015
Results First Submitted: November 2, 2017
Results First Posted: January 30, 2018
Last Update Posted: January 30, 2018