A Study Assessing the Efficacy and Safety of Sarilumab Ad... | NCT02293902 | Trialant
NCT02293902
Sponsor
Sanofi
Status
Completed
Last Update Posted
Jan 30, 2018Actual
Enrollment
243Actual
Phase
Phase 3
Conditions
Rheumatoid Arthritis
Interventions
Sarilumab SAR153191 (REGN88)
Placebo (for sarilumab)
Methotrexate
Folic acid
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT02293902
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
EFC14059
Secondary IDs
ID
Type
Description
Link
U1111-1155-7401
Other Identifier
UTN
Brief Title
A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)
Official Title
A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy
Acronym
Not provided
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Jan 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2014
Primary Completion Date
Oct 2016Actual
Completion Date
Oct 2016Actual
First Submitted Date
Nov 13, 2014
First Submission Date that Met QC Criteria
Nov 18, 2014
First Posted Date
Nov 19, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 23, 2017
Results First Submitted that Met QC Criteria
Jan 5, 2018
Results First Posted Date
Jan 30, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 5, 2018
Last Update Posted Date
Jan 30, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SanofiINDUSTRY
Collaborators
Name
Class
Regeneron Pharmaceuticals
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Primary Objective:
-To demonstrate that sarilumab added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Japanese RA participants with an inadequate response to MTX.
Secondary Objective:
-To assess the safety of sarilumab added to MTX in Japanese RA participants with an inadequate response to MTX.
Detailed Description
The total duration of study was expected up to 62 weeks (screening period of 4 weeks, treatment period of 52 weeks, and a 6-week post treatment observation).
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
243Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Sarilumab 150 mg/150 mg
Experimental
Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either tender joint count [TJC] or swollen joint count [SJC], or with any other clear lack of efficacy based on investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.
Drug: Sarilumab SAR153191 (REGN88)
Drug: Methotrexate
Drug: Folic acid
Sarilumab 200 mg/200 mg
Experimental
Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.
Drug: Sarilumab SAR153191 (REGN88)
Drug: Methotrexate
Drug: Folic acid
Placebo/Sarilumab 150 mg
Placebo Comparator
Placebo (for sarilumab) SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by a single-blind period in which participants were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Sarilumab SAR153191 (REGN88)
Drug
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Placebo/Sarilumab 150 mg
Placebo/Sarilumab 200 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24
American College of Rheumatology (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 questionnaire disability index [HAQ-DI], with scoring range of 0 [better health] - 3 [worst health]). ACR20 response was defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments.
Week 24
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AEs that developed or worsened or became serious during double-blind on-treatment period, single-blind on-treatment period up to 6-week post-treatment follow-up period (up to Week 58) were considered treatment-emergent.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Diagnosis of RA, according to the American College of Rheumatology/The European League Against Rheumatism (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria with >=3 months disease duration.
Moderately to severely active RA defined as:
At least 8 of 68 tender joints and 6 of 66 swollen joints at screening visit.
High sensitivity C-Reactive Protein (hs-CRP) >=6mg/L at screening visit.
Exclusion criteria:
Participants <20 or >75 years of age.
Treatment with any Disease-modifying antirheumatic drug (DMARD) other than MTX or biologic agent without the appropriate off-drug period prior to screening.
Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Tanaka Y, Takahashi T, Van Hoogstraten H, Praestgaard A, Kato N, Kameda H. Haemoglobin changes and disease activity in Japanese patients with rheumatoid arthritis treated with sarilumab. Clin Exp Rheumatol. 2023 May;41(5):1129-1139. doi: 10.55563/clinexprheumatol/jq9u8f. Epub 2022 Oct 28.
Participants were randomized to receive sarilumab 150 mg, 200 mg or placebo in a double-blind period up to Week 24 followed by single-blind period during which participants originally given placebo were switched to sarilumab 150 mg or 200 mg; those originally given 150 mg, 200 mg in double-blind period, continued with same treatment up to Week 52.
Recruitment Details
The study was conducted at 95 centers in Japan between 06 November 2014 and 28 October 2016. A total of 388 participants were screened, of whom 243 participants were randomized and 145 were screen failures.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Placebo (for sarilumab) subcutaneous (SC) injection once every 2 weeks (q2w) in combination with methotrexate (MTX) and folic acid in double-blind period up to Week 24. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
Placebo (for sarilumab) SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by a single-blind period in which participants were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.
Drug: Sarilumab SAR153191 (REGN88)
Other: Placebo (for sarilumab)
Drug: Methotrexate
Drug: Folic acid
Sarilumab 150 mg/150 mg
Sarilumab 200 mg/200 mg
Placebo (for sarilumab)
Other
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Placebo/Sarilumab 150 mg
Placebo/Sarilumab 200 mg
Methotrexate
Drug
Dispensed according to local practice.
Placebo/Sarilumab 150 mg
Placebo/Sarilumab 200 mg
Sarilumab 150 mg/150 mg
Sarilumab 200 mg/200 mg
Folic acid
Drug
Dispensed according to local practice.
Placebo/Sarilumab 150 mg
Placebo/Sarilumab 200 mg
Sarilumab 150 mg/150 mg
Sarilumab 200 mg/200 mg
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
Criteria for potentially clinically significant vital sign abnormalities:
Systolic blood pressure supine (SBP[S]): <=95 mmHg and decrease from baseline (DFB) >=20 mmHg; >=160 mmHg and increase from baseline (IFB) >=20 mmHg
Diastolic blood pressure supine (DBP[S]): <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg
Heart rate supine (HR[S]): <=50 beats per minute (bpm) and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm
Weight: >=5% DFB; >=5% IFB
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
Criteria for potentially clinically significant ECG abnormalities:
PR Interval: >200 millisecond (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
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
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)
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters
Criteria for potentially clinically significant abnormalities:
Glucose: <=3.9 mmol/L and <LLN; >=11.1 mmol/L unfasted or >=7 mmol/L fasted
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
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes
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
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
Criteria for potentially clinically significant abnormalities:
Creatinine: >=150 micromol/L; >=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
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
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; >2 ULN
Unconjugated bilirubin: >1.5 ULN; >2 ULN
ALT and TBILI: ALT >3 ULN and TBILI >2 ULN
CBILI and TBILI: CBILI >35% TBILI and TBILI >1.5 ULN
Albumin: <=25 g/L
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm : Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
Asahikawa-Shi
Japan
Investigational Site Number 392035
Asahikawa-Shi
Japan
Investigational Site Number 392070
Beppu-Shi
Japan
Investigational Site Number 392036
Chiba
Japan
Investigational Site Number 392083
Chūōku
Japan
Investigational Site Number 392047
Fuchu-Shi
Japan
Investigational Site Number 392004
Fukui-shi
Japan
Investigational Site Number 392007
Fukuoka
Japan
Investigational Site Number 392038
Fukuoka
Japan
Investigational Site Number 392039
Fukuoka
Japan
Investigational Site Number 392078
Fukushima
Japan
Investigational Site Number 392054
Funabashi-Shi
Japan
Investigational Site Number 392015
Hachioji-Shi
Japan
Investigational Site Number 392085
Hannan-Shi
Japan
Investigational Site Number 392091
Hiroshima
Japan
Investigational Site Number 392098
Hiroshima
Japan
Investigational Site Number 392009
Hitachi-Naka
Japan
Investigational Site Number 392011
Hitachi-Naka
Japan
Investigational Site Number 392030
Ichinomiya-Shi
Japan
Investigational Site Number 392002
Iizuka-Shi
Japan
Investigational Site Number 392019
Kagoshima
Japan
Investigational Site Number 392066
Kamakura-Shi
Japan
Investigational Site Number 392086
Kamogawa-Shi
Japan
Investigational Site Number 392050
Kato-Shi
Japan
Investigational Site Number 392037
Kawachi-Nagano-Shi
Japan
Investigational Site Number 392093
Kawagoe-Shi
Japan
Investigational Site Number 392099
Kawasaki-Shi
Japan
Investigational Site Number 392016
Kirishima-Shi
Japan
Investigational Site Number 392013
Kitakyushu-Shi
Japan
Investigational Site Number 392024
Kitakyushu-Shi
Japan
Investigational Site Number 392045
Kitakyushu-Shi
Japan
Investigational Site Number 392063
Kiyose-Shi
Japan
Investigational Site Number 392051
Kobe
Japan
Investigational Site Number 392097
Kochi
Japan
Investigational Site Number 392040
Koushi-Shi
Japan
Investigational Site Number 392069
Kumamoto
Japan
Investigational Site Number 392089
Kurashiki-Shi
Japan
Investigational Site Number 392065
Kushiro
Japan
Investigational Site Number 392026
Matsuyama
Japan
Investigational Site Number 392081
Matsuyama
Japan
Investigational Site Number 392094
Matsuyama
Japan
Investigational Site Number 392042
Meguro-Ku
Japan
Investigational Site Number 392082
Meguro-Ku
Japan
Investigational Site Number 392012
Mito
Japan
Investigational Site Number 392034
Miyagi-Gun
Japan
Investigational Site Number 392053
Morioka
Japan
Investigational Site Number 392032
Nagano
Japan
Investigational Site Number 392064
Nagasaki
Japan
Investigational Site Number 392043
Nagoya
Japan
Investigational Site Number 392056
Nagoya
Japan
Investigational Site Number 392076
Nagoya
Japan
Investigational Site Number 392080
Nagoya
Japan
Investigational Site Number 392031
Nakano
Japan
Investigational Site Number 392046
Narashino-Shi
Japan
Investigational Site Number 392067
Narashino-Shi
Japan
Investigational Site Number 392044
Nishinomiya-Shi
Japan
Investigational Site Number 392062
Okayama
Japan
Investigational Site Number 392008
Omura-Shi
Japan
Investigational Site Number 392057
Osaka
Japan
Investigational Site Number 392060
Osaka
Japan
Investigational Site Number 392061
Osaka
Japan
Investigational Site Number 392096
Osaka
Japan
Investigational Site Number 392027
Osaki-Shi
Japan
Investigational Site Number 392059
Ōita
Japan
Investigational Site Number 392049
Sagamihara-Shi
Japan
Investigational Site Number 392072
Saitama-Shi
Japan
Investigational Site Number 392075
Sakaishi
Japan
Investigational Site Number 392014
Sapporo
Japan
Investigational Site Number 392068
Sapporo
Japan
Investigational Site Number 392073
Sapporo
Japan
Investigational Site Number 392006
Sasebo-Shi
Japan
Investigational Site Number 392021
Sendai
Japan
Investigational Site Number 392022
Sendai
Japan
Investigational Site Number 392033
Sendai
Japan
Investigational Site Number 392071
Sendai
Japan
Investigational Site Number 392100
Sendai
Japan
Investigational Site Number 392029
Shizuoka
Japan
Investigational Site Number 392025
Sumida-Ku
Japan
Investigational Site Number 392092
Sumida-Ku
Japan
Investigational Site Number 392023
Takaoka-Shi
Japan
Investigational Site Number 392095
Takarazuka-Shi
Japan
Investigational Site Number 392020
Takasaki-Shi
Japan
Investigational Site Number 392088
Takatsuki-Shi
Japan
Investigational Site Number 392018
Tokorozawa-Shi
Japan
Investigational Site Number 392003
Tomakomai-Shi
Japan
Investigational Site Number 392005
Tomakomai-Shi
Japan
Investigational Site Number 392077
Tonami-Shi
Japan
Investigational Site Number 392052
Toshima-Ku
Japan
Investigational Site Number 392058
Toyama
Japan
Investigational Site Number 392055
Toyonaka-Shi
Japan
Investigational Site Number 392074
Urasoe-Shi
Japan
Investigational Site Number 392079
Urayasu-Shi
Japan
Investigational Site Number 392048
Yokohama
Japan
Investigational Site Number 392090
Yokohama
Japan
Investigational Site Number 392101
Yokohama
Japan
Tanaka Y, Wada K, Takahashi Y, Hagino O, van Hoogstraten H, Graham NMH, Kameda H. Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a randomized, placebo-controlled phase III trial in Japan. Arthritis Res Ther. 2019 Mar 20;21(1):79. doi: 10.1186/s13075-019-1856-4.
Sarilumab 150 mg/150 mg
Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
FG002
Sarilumab 200 mg/200 mg
Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
FG003
Placebo/Sarilumab 150 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
FG004
Placebo/Sarilumab 200 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
FG00082 subjects
FG00181 subjects
FG00280 subjects
FG0030 subjects
FG0040 subjects
Treated
FG00081 subjects
FG00181 subjects
FG00280 subjects
FG0030 subjects
FG0040 subjects
Rescued
Included both participants who completed and did not complete the study.
FG00044 subjects
FG0016 subjects
FG0028 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG00071 subjects42 rescued and 29 not rescued completed.
FG00174 subjects6 rescued and 68 not rescued completed.
FG00270 subjects8 rescued and 62 not rescued completed.
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG00011 subjects
FG0017 subjects
FG00210 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0016 subjects
FG0028 subjects
FG0030 subjects
FG0040 subjects
Lack of Efficacy
FG0005 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Randomized but not Treated
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Single-Blind Period (Week 25 to Week 52)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00174 subjects68 participants not rescued continued same treatment and 6 rescued continued open label treatment.
FG00270 subjects62 participants not rescued continued same treatment and 8 rescued continued open label treatment.
FG00334 subjects14 participants not rescued were switched and 20 rescued continued open label treatment.
FG00437 subjects15 participants not rescued were switched and 22 rescued continued open label treatment.
COMPLETED
FG0000 subjects
FG00166 subjects5 rescued and 61 not rescued completed.
FG00268 subjects8 rescued and 60 not rescued completed.
FG003
NOT COMPLETED
FG0000 subjects
FG0018 subjects
FG0022 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0017 subjects
FG0021 subjects
FG003
Analysis was performed on randomized population which included all participants who had been allocated to a randomized treatment regardless of whether the treatment was actually administered.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
BG001
Sarilumab 150 mg/150 mg
Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment .
BG002
Sarilumab 200 mg/200 mg
Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment .
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00082
BG00181
BG00280
BG003243
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00053.4± 11.5
BG00156.1± 9.5
BG00255.3± 11.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00065
BG00163
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24
American College of Rheumatology (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 questionnaire disability index [HAQ-DI], with scoring range of 0 [better health] - 3 [worst health]). ACR20 response was defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments.
Analysis was performed on modified intent-to-treat (mITT) population which included all randomized participants who received at least one dose of investigational medicinal product (IMP) and had an evaluable primary endpoint, irrespective of compliance with the study protocol and procedures.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Placebo
Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
OG001
Sarilumab 150 mg
Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
OG002
Sarilumab 200 mg
Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
Units
Counts
Participants
OG00081
OG00181
OG00280
Title
Denominators
Categories
Title
Measurements
OG00014.8
OG00167.9
OG00257.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis was performed using Cochran-Mantel-Haenszel (CMH) test stratified by prior biologic use (Yes, No) and weight at screening (<55 kg, >=55 kg).
Cochran-Mantel-Haenszel
<0.0001
Threshold for significance at 0.05 level.
Odds Ratio (OR)
12.185
2-Sided
95
5.583
26.594
Superiority
Placebo vs. Sarilumab 150 mg
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AEs that developed or worsened or became serious during double-blind on-treatment period, single-blind on-treatment period up to 6-week post-treatment follow-up period (up to Week 58) were considered treatment-emergent.
Analysis was performed on safety population which included all randomized participants who actually received at least one dose or a partial dose of IMP.
Posted
Number
participants
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
ID
Title
Description
OG000
Placebo
Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
OG001
Secondary
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
Criteria for potentially clinically significant vital sign abnormalities:
Systolic blood pressure supine (SBP[S]): <=95 mmHg and decrease from baseline (DFB) >=20 mmHg; >=160 mmHg and increase from baseline (IFB) >=20 mmHg
Diastolic blood pressure supine (DBP[S]): <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg
Heart rate supine (HR[S]): <=50 beats per minute (bpm) and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm
Weight: >=5% DFB; >=5% IFB
Analysis was performed on safety population.
Posted
Number
participants
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
ID
Title
Description
OG000
Placebo
Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
OG001
Sarilumab 150 mg/150 mg
Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
Secondary
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
Criteria for potentially clinically significant ECG abnormalities:
PR Interval: >200 millisecond (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
Analysis was performed on safety population.
Posted
Number
participants
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
ID
Title
Description
OG000
Placebo
Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
OG001
Sarilumab 150 mg/150 mg
Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
OG002
Sarilumab 200 mg/200 mg
Secondary
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
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)
Analysis was performed on safety population.
Posted
Number
participants
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
ID
Title
Description
OG000
Placebo
Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
OG001
Sarilumab 150 mg/150 mg
Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
Secondary
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters
Criteria for potentially clinically significant abnormalities:
Glucose: <=3.9 mmol/L and <LLN; >=11.1 mmol/L unfasted or >=7 mmol/L fasted
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
Analysis was performed on safety population.
Posted
Number
participants
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
ID
Title
Description
OG000
Placebo
Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
OG001
Sarilumab 150 mg/150 mg
Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
OG002
Sarilumab 200 mg/200 mg
Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
Secondary
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes
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
Analysis was performed on safety population.
Posted
Number
participants
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
ID
Title
Description
OG000
Placebo
Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
OG001
Sarilumab 150 mg/150 mg
Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
OG002
Sarilumab 200 mg/200 mg
Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
Secondary
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
Criteria for potentially clinically significant abnormalities:
Creatinine: >=150 micromol/L; >=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
Analysis was performed on safety population.
Posted
Number
participants
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
ID
Title
Description
OG000
Placebo
Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
OG001
Sarilumab 150 mg/150 mg
Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
OG002
Sarilumab 200 mg/200 mg
Secondary
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
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; >2 ULN
Unconjugated bilirubin: >1.5 ULN; >2 ULN
ALT and TBILI: ALT >3 ULN and TBILI >2 ULN
CBILI and TBILI: CBILI >35% TBILI and TBILI >1.5 ULN
Albumin: <=25 g/L
Analysis was performed on safety population.
Posted
Number
participants
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm : Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
ID
Title
Description
OG000
Placebo
Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
OG001
Sarilumab 150 mg/150 mg
Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
Time Frame
For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58.
Description
Reported AEs are treatment-emergent AEs that is AEs that developed or worsened or became serious during double-blind on-treatment period, single-blind on-treatment period up to 6-week post-treatment follow-up period (up to Week 58).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
6
81
35
81
EG001
Sarilumab 150 mg/150 mg
Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
8
81
67
81
EG002
Sarilumab 200 mg/200 mg
Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
5
80
59
80
EG003
Placebo/Sarilumab 150 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
0
14
12
14
EG004
Placebo/Sarilumab 200 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
2
15
13
15
EG005
Sarilumab Rescue
Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits (at least 4 weeks apart) in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
4
58
48
58
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG0030 affected14 at risk
EG0040 affected15 at risk
EG0051 affected58 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0011 affected81 at risk
EG0020 affected80 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0001 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Macular fibrosis
Eye disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0021 affected80 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0011 affected81 at risk
EG0020 affected80 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0001 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Gastroenteritis bacterial
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0011 affected81 at risk
EG0020 affected80 at risk
EG003
Infective myositis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0011 affected81 at risk
EG0020 affected80 at risk
EG003
Pharyngeal abscess
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0011 affected81 at risk
EG0020 affected80 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0011 affected81 at risk
EG0020 affected80 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Sepsis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0011 affected81 at risk
EG0020 affected80 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0001 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0021 affected80 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0011 affected81 at risk
EG0020 affected80 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0002 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Scoliosis
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0011 affected81 at risk
EG0020 affected80 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0001 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0021 affected80 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0021 affected80 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0021 affected80 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG0030 affected14 at risk
EG0041 affected15 at risk
EG0050 affected58 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0012 affected81 at risk
EG0021 affected80 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG00110 affected81 at risk
EG0029 affected80 at risk
EG003
Blepharitis
Eye disorders
MedDRA 17.1
Systematic Assessment
EG0001 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Anal erosion
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0002 affected81 at risk
EG0012 affected81 at risk
EG0023 affected80 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0012 affected81 at risk
EG0022 affected80 at risk
EG003
Gastric polyps
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Gastritis erosive
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0023 affected80 at risk
EG003
Lip erosion
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 affected81 at risk
EG0010 affected81 at risk
EG0024 affected80 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0003 affected81 at risk
EG0016 affected81 at risk
EG0028 affected80 at risk
EG003
Injection site erythema
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0018 affected81 at risk
EG0027 affected80 at risk
EG003
Injection site pruritus
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0015 affected81 at risk
EG0024 affected80 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0021 affected80 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 17.1
Systematic Assessment
EG0004 affected81 at risk
EG0018 affected81 at risk
EG0027 affected80 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0022 affected80 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0001 affected81 at risk
EG0014 affected81 at risk
EG0021 affected80 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Cystitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0001 affected81 at risk
EG0015 affected81 at risk
EG0021 affected80 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Furuncle
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0001 affected81 at risk
EG0012 affected81 at risk
EG0026 affected80 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0001 affected81 at risk
EG0012 affected81 at risk
EG0020 affected80 at risk
EG003
Influenza
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0001 affected81 at risk
EG0011 affected81 at risk
EG0022 affected80 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG00012 affected81 at risk
EG00127 affected81 at risk
EG00223 affected80 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0011 affected81 at risk
EG0020 affected80 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0002 affected81 at risk
EG0010 affected81 at risk
EG0022 affected80 at risk
EG003
Otitis media
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0014 affected81 at risk
EG0020 affected80 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0001 affected81 at risk
EG0014 affected81 at risk
EG0022 affected80 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0004 affected81 at risk
EG0018 affected81 at risk
EG0027 affected80 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0021 affected80 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0012 affected81 at risk
EG0021 affected80 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0004 affected81 at risk
EG0017 affected81 at risk
EG0024 affected80 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0012 affected81 at risk
EG0020 affected80 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0014 affected81 at risk
EG0022 affected80 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0021 affected80 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0012 affected81 at risk
EG0020 affected80 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0011 affected81 at risk
EG0021 affected80 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0021 affected80 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0002 affected81 at risk
EG0012 affected81 at risk
EG0024 affected80 at risk
EG003
Lymphangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0020 affected80 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected81 at risk
EG0021 affected80 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0001 affected81 at risk
EG0017 affected81 at risk
EG0024 affected80 at risk
EG003
Generalised erythema
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0011 affected81 at risk
EG0020 affected80 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0002 affected81 at risk
EG0012 affected81 at risk
EG0020 affected80 at risk
EG003
Hypertension
Vascular disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected81 at risk
EG0014 affected81 at risk
EG0025 affected80 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Trial Transparency Team
Sanofi
Contact-US@sanofi.com
ID
Term
D001172
Arthritis, Rheumatoid
Ancestor Terms
ID
Term
D001168
Arthritis
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D012216
Rheumatic Diseases
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000592401
sarilumab
D008727
Methotrexate
D005492
Folic Acid
Ancestor Terms
ID
Term
D000630
Aminopterin
D011622
Pterins
D011621
Pteridines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
0 subjects
33 subjects
20 rescued and 13 not rescued completed.
FG00431 subjects18 rescued and 13 not rescued completed.
6 subjects
1 subjects
FG0046 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
54.9
± 10.7
61
BG003189
Male
BG00017
BG00118
BG00219
BG00354
OG000
OG002
Analysis was performed using CMH test stratified by prior biologic use (Yes, No) and weight at screening (<55 kg, >=55 kg).
Cochran-Mantel-Haenszel
<0.0001
Threshold for significance at 0.05 level.
Odds Ratio (OR)
7.227
2-Sided
95
3.446
15.158
Superiority
Placebo vs. Sarilumab 200 mg
Sarilumab 150 mg/150 mg
Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
OG002
Sarilumab 200 mg/200 mg
Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
OG003
Placebo/Sarilumab 150 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
OG004
Placebo/Sarilumab 200 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
OG005
Sarilumab Rescue
Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
Units
Counts
Participants
OG00081
OG00181
OG00280
OG00314
OG00415
OG00558
Title
Denominators
Categories
Treatment Emergent AEs
Title
Measurements
OG00049
OG00176
OG00271
OG00312
OG00413
OG00554
Treatment Emergent SAEs
Title
Measurements
OG0006
OG0018
OG0025
OG003
OG002
Sarilumab 200 mg/200 mg
Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
OG003
Placebo/Sarilumab 150 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
OG004
Placebo/Sarilumab 200 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
OG005
Sarilumab Rescue
Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
Units
Counts
Participants
OG00081
OG00181
OG00280
OG00314
OG00415
OG00558
Title
Denominators
Categories
SBP(S) <=95 mmHg and DFB >=20 mmHg
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
ParticipantsOG00415
ParticipantsOG00558
Title
Measurements
OG0002
OG0014
OG0021
OG003
SBP(S) >=160 mmHg and IFB >=20 mmHg
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
DBP(S) <=45 mmHg and DFB >=10 mmHg
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
DBP(S)>=110 mmHg and IFB >=10 mmHg
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
SBP(O) <=-20 mmHg
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
DBP(O) <=-10 mmHg
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
HR(S) <=50 bpm and DFB >=20 bpm
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
HR(S) >=120 bpm and IFB >=20 bpm
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
Weight >=5% DFB
ParticipantsOG00080
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
Weight >=5% IFB
ParticipantsOG00080
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
OG003
Placebo/Sarilumab 150 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
OG004
Placebo/Sarilumab 200 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
OG005
Sarilumab Rescue
Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
Units
Counts
Participants
OG00081
OG00181
OG00280
OG00314
OG00415
OG00558
Title
Denominators
Categories
PR Interval >200 ms
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
ParticipantsOG00415
ParticipantsOG00558
Title
Measurements
OG0006
OG0019
OG0025
OG003
PR Interval >200 ms and IFB >=25%
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
PR Interval >220 ms
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
PR Interval >220 ms and IFB >=25%
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
PR Interval >240 ms
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
PR Interval >240 ms and IFB >=25%
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
QRS Interval >110 ms
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
QRS Interval >110 ms and IFB >=25%
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
QRS Interval >120 ms
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
QRS Interval >120 ms and IFB >=25%
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
QT Interval >500 ms
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
QTc B >450 ms
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
QTc B >480 ms
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
QTc B >500 ms
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
QTc B IFB >30 and <=60 ms
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
QTc B IFB >60 ms
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
QTc F>450 ms
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
QTc F>480 ms
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
QTc F>500 ms
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
QTc F IFB >30 and <=60 ms
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
QTc F IFB >60 ms
ParticipantsOG00077
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
OG002
Sarilumab 200 mg/200 mg
Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
OG003
Placebo/Sarilumab 150 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
OG004
Placebo/Sarilumab 200 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
OG005
Sarilumab Rescue
Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits (at least 4 weeks apart) in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
Units
Counts
Participants
OG00081
OG00181
OG00280
OG00314
OG00415
OG00558
Title
Denominators
Categories
Hemoglobin <=115 g/L (M) or <=95 g/L (F)
Title
Measurements
OG0009
OG0014
OG0025
OG0030
OG0041
OG0055
Hemoglobin >=185 g/L (M) or >=165 g/L (F)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin DFB >=20 g/L
Title
Measurements
OG0004
OG0010
OG0023
OG003
Hematocrit <=0.37 v/v (M) or <=0.32 v/v (F)
Title
Measurements
OG00017
OG00110
OG00214
OG003
Hematocrit >=0.55 v/v (M) or >=0.5 v/v (F)
Title
Measurements
OG0000
OG0010
OG0020
OG003
RBC >=6 Tera/L
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelets <50 Giga/L
Title
Measurements
OG0000
OG0011
OG0020
OG003
Platelets >=50 and <100 Giga/L
Title
Measurements
OG0000
OG0012
OG0024
OG003
Platelets >=700 Giga/L
Title
Measurements
OG0001
OG0010
OG0020
OG003
WBC <3.0 Giga/L (NB) or <2.0 Giga/L (B)
Title
Measurements
OG0000
OG00130
OG00223
OG003
WBC >=16.0 Giga/L
Title
Measurements
OG0000
OG0015
OG0025
OG003
Neutrophils <1.5 Giga/L (NB) or <1.0 Giga/L (B)
Title
Measurements
OG0000
OG00131
OG00224
OG003
Neutrophils <1.0 Giga/L
Title
Measurements
OG0000
OG00111
OG0026
OG003
Lymphocytes <0.5 Giga/L
Title
Measurements
OG0003
OG0016
OG0023
OG003
Lymphocytes >=0.5 Giga/L and <LLN
Title
Measurements
OG00023
OG00129
OG00232
OG003
Lymphocytes >4.0 Giga/L
Title
Measurements
OG0000
OG0010
OG0020
OG003
Monocytes >0.7 Giga/L
Title
Measurements
OG0009
OG00110
OG0027
OG003
Basophils >0.1 Giga/L
Title
Measurements
OG0006
OG00111
OG0029
OG003
Eosinophils>0.5 Giga/L or >ULN(if ULN>=0.5 Giga/L)
Title
Measurements
OG0001
OG0012
OG0021
OG003
OG003
Placebo/Sarilumab 150 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
OG004
Placebo/Sarilumab 200 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
OG005
Sarilumab Rescue
Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits (at least 4 weeks apart) in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
Units
Counts
Participants
OG00081
OG00181
OG00280
OG00314
OG00415
OG00558
Title
Denominators
Categories
Glucose <=3.9 mmol/L and <LLN
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
ParticipantsOG00415
ParticipantsOG00558
Title
Measurements
OG0000
OG0010
OG0022
OG003
Glucose>=11.1 mmol/L unfasted or >=7 mmol/L fasted
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG003
HbA1c >8%
ParticipantsOG00079
ParticipantsOG00181
ParticipantsOG00278
ParticipantsOG00314
Total cholesterol >=6.2 mmol/L
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
Total cholesterol >=7.74 mmol/L
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
LDL cholesterol >=4.1 mmol/L
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
LDL cholesterol >=4.9 mmol/L
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
Triglycerides >=4.6 mmol/L
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
Triglycerides >=5.6 mmol/L
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00314
OG003
Placebo/Sarilumab 150 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
OG004
Placebo/Sarilumab 200 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
OG005
Sarilumab Rescue
Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits (at least 4 weeks apart) in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
Units
Counts
Participants
OG00081
OG00181
OG00280
OG00314
OG00415
OG00558
Title
Denominators
Categories
Sodium <=129 mmol/L
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
Sodium >=160 mmol/L
Title
Measurements
OG0000
OG0010
OG0021
OG003
Potassium <3 mmol/L
Title
Measurements
OG0000
OG0010
OG0021
OG003
Potassium >=5.5 mmol/L
Title
Measurements
OG0000
OG0010
OG0022
OG003
Chloride <80 mmol/L
Title
Measurements
OG0000
OG0010
OG0020
OG003
Chloride >115 mmol/L
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
OG003
Placebo/Sarilumab 150 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
OG004
Placebo/Sarilumab 200 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
OG005
Sarilumab Rescue
Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits (at least 4 weeks apart) in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
Units
Counts
Participants
OG00081
OG00181
OG00280
OG00314
OG00415
OG00558
Title
Denominators
Categories
Creatinine >=150 micromol/L
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0041
OG0050
Creatinine >=30% change from baseline
Title
Measurements
OG0005
OG00118
OG00222
OG003
Creatinine >=100% change from baseline
Title
Measurements
OG0000
OG0011
OG0021
OG003
Creatinine clearance <15 mL/min
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine clearance >=15 to <30 mL/min
Title
Measurements
OG0000
OG0011
OG0020
OG003
Creatinine clearance >=30 to <60 mL/min
Title
Measurements
OG0006
OG00112
OG00214
OG003
Creatinine clearance >=60 to <90 mL/min
Title
Measurements
OG00041
OG00145
OG00242
OG003
Blood urea nitrogen >=17 mmol/L
Title
Measurements
OG0000
OG0010
OG0020
OG003
Uric acid <120 micromol/L
Title
Measurements
OG0000
OG0011
OG0022
OG003
Uric acid >408 micromol/L
Title
Measurements
OG0008
OG00113
OG00214
OG003
OG002
Sarilumab 200 mg/200 mg
Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
OG003
Placebo/Sarilumab 150 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
OG004
Placebo/Sarilumab 200 mg
Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
OG005
Sarilumab Rescue
Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits (at least 4 weeks apart) in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.