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CompletedNCT01061736RA-MOBILITYUpdated Jun 28, 2017Results posted

Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients

A Phase 2/3 interventional study of Sarilumab and Placebo (for sarilumab) in Rheumatoid Arthritis, sponsored by Sanofi. Completed at 262 sites in 36 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-06-28.

Sponsored by Sanofi · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
1,675
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Primary Objectives:

Part A (dose ranging study):

To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks.

Part B (pivotal study):

To demonstrate that sarilumab added to MTX was effective in:

  • reduction of signs and symptoms of rheumatoid arthritis at 24 weeks
  • inhibition of progression of structural damage at 52 weeks
  • improvement in physical function at 16 weeks

Secondary Objectives:

Part B:

To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks

To assess the safety of sarilumab added to MTX

To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.

Read the detailed description

The total study duration for a participant was 16-22 weeks (Part A) and 56-62 weeks (Part B) broken down as follows:

  • Screening: Up to 4 weeks
  • Treatment: 12 weeks (Part A) and 52 weeks (Part B)*
  • Follow-up: 6 weeks (for participants who would not continue in the long-term extension study).

'*' Participants successfully completing their treatment period would be offered the opportunity to enter the long term extension study LTS11210 (SARIL-RA-EXTEND) (NCT01146652).

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.

This study's enrollment of 1,675 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of rheumatoid arthritis ≥3 months duration

  • Active disease defined as:

    • at least 8/68 tender joints and 6/66 swollen joints,
    • high sensitivity C-reactive protein (hs-CRP) >6 mg/l,
    • continuous treatment with MTX for at least 12 weeks prior to baseline visit and on stable dose for at least 6 weeks prior to screening visit.

Part B only:

  • Bone erosion based on documented X-ray prior to first study drug intake, or
  • Cyclic Citrullinated Peptide (CCP) positive, or
  • Rheumatoid Factor (RF) positive.

Exclusion criteria

Exclusion criteria:

  • Age \<18 years or >75 years.
  • Treatment with disease-modifying antirheumatic drugs (DMARDs) other than MTX within 4 weeks or 12 weeks prior to screening (depending on DMARDs).
  • Past history of non-response to prior Tumor Necrosis Factor (TNF) or biologic treatment.
  • Any past or current biologic agents for the treatment of rheumatoid arthritis within 3 months.
  • Use of parenteral glucocorticoids or intraarticular glucocorticoids within 4 weeks prior to screening visit.
  • Use of oral glucocorticoid greater than 10mg/day or equivalent/day, or a change in dosage within 4 weeks prior to baseline visit.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
1,675 participants (actual)

Study arms

  • Experimental
    Part A: SAR 100 mg qw

    Sarilumab 100 mg subcutaneous (SC) injection weekly (qw) on top of MTX for 12 weeks.

    Drug: Sarilumab · Drug: Methotrexate · Drug: Folic Acid

  • Experimental
    Part A: SAR 150 mg qw

    Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.

    Drug: Sarilumab · Drug: Methotrexate · Drug: Folic Acid

  • Experimental
    Part A: SAR 100 mg q2w

    Sarilumab 100 mg SC injection every other week (q2w) alternating with placebo on top of MTX for 12 weeks.

    Drug: Sarilumab · Drug: Placebo (for sarilumab) · Drug: Methotrexate · Drug: Folic Acid

  • Experimental
    Part A: SAR 150 mg q2w

    Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.

    Drug: Sarilumab · Drug: Placebo (for sarilumab) · Drug: Methotrexate · Drug: Folic Acid

  • Experimental
    Part A: SAR 200 mg q2w

    Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.

    Drug: Sarilumab · Drug: Placebo (for sarilumab) · Drug: Methotrexate · Drug: Folic Acid

  • Placebo comparator
    Part A: Placebo qw

    Placebo (for sarilumab) qw on top of MTX for 12 weeks.

    Drug: Placebo (for sarilumab) · Drug: Methotrexate · Drug: Folic Acid

  • Experimental
    Part B Cohort 1: Non-selected Doses

    Sarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections as in Part A on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210).

    Drug: Sarilumab · Drug: Placebo (for sarilumab) · Drug: Methotrexate · Drug: Folic Acid

  • Experimental
    Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)

    Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with open-label highest dose of sarilumab.

    Drug: Sarilumab · Drug: Methotrexate · Drug: Folic Acid

  • Experimental
    Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)

    Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with open-label highest dose of sarilumab.

    Drug: Sarilumab · Drug: Methotrexate · Drug: Folic Acid

  • Experimental
    Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)

    Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with open-label highest dose of sarilumab.

    Drug: Placebo (for sarilumab) · Drug: Methotrexate · Drug: Folic Acid

Interventions

  • DrugSarilumab

    Pharmaceutical form: solution for injection Route of administration: subcutaneous

    Also known as: SAR153191, REGN88

  • DrugPlacebo (for sarilumab)

    Pharmaceutical form: solution for injection Route of administration: subcutaneous

  • DrugMethotrexate

    Same weekly dose as received prior to enrollment

  • DrugFolic Acid

    According to local standard

06

What researchers measure

Primary outcomes

  1. Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

    ACR20 response was defined, based on guidelines set forth by the American College of Rheumatology (ACR), as ≥20 % improvement in tender joint count and swollen joint count as well as ≥20% improvement in at least 3 of 5 following measures: C-Reactive Protein (CRP), Participant assessment of pain; Participant's global assessment of disease activity; Physician global assessment of disease activity; and Health Assessment Question-Disability Index (HAQ-DI). Missing data imputed by Last Observation Carried Forward (LOCF).

    Time frame: Baseline to Week 12

  2. Part B: Percentage of Participants Achieving ACR20 Response at Week 24

    ACR20 improvement responses were determined without imputation of missing post-baseline values. In addition data collected after treatment discontinuation or rescue was set to missing. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.

    Time frame: Baseline to Week 24

  3. Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16

    HAQ-DI was a participant-reported questionnaire that assesses the difficulty of performing daily activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Overall score range from 0=least difficulty to 3=extreme difficulty. An increase in the score indicates a worsening of physical function while a decrease in the score represents improvement. Data collected after treatment discontinuation was set to missing.

    Time frame: Baseline, Week 16

  4. Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52

    The Sharp method modified by D. van der Heijde involves separate scores for erosions and joint space narrowing based on radiographs to assess the degree of structural damage. Total score range from 0 (normal) to 448 (worst possible total score). An increase in total score represents progression of structural damage. Missing data were imputed by the linear extrapolation method.

    Time frame: Baseline, Week 52

Secondary outcomes

  1. Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52

    Major clinical response was defined as an ACR70 response maintained for at least 24 consecutive weeks. ACR70 response uses the same criteria as for ACR20 but requires 70% improvement. In the primary approach, data collected after treatment discontinuation or rescue was set to missing. No imputation of missing post-baseline values was performed. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.

    Time frame: Baseline up to Week 52

07

Results

Posted Jun 28, 2017

Participant flow

The study was conducted at 247 centers in 36 countries. Overall, 3715 participants were screened between March 2010 and July 2012, 2040 of whom were screen failures. Screen failures were mainly due to failure to meet the inclusion criterion for severity of the disease and/or due to meeting the exclusion criterion.

Participant flow — Overall Study
MilestonePart A: SAR 100 mg qwPart A: SAR 150 mg qwPart A: SAR 100 mg q2wPart A: SAR 150 mg q2wPart A: SAR 200 mg q2wPart A: Placebo qwPart B Cohort 1: Non-selected DosesPart B: SAR 150 mg q2w (Cohort 1 [Selected Dose]+Cohort 2)Part B: SAR 200 mg q2w (Cohort 1 [Selected Dose]+Cohort 2)Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)
Started50505151525284430427428
Treated50505151515284428426428
Rescued00000006155168
Completed3746454845490336330354
Not completed134637384949774
Withdrew: Dose regimen not selected00000079000
Withdrew: Adverse event13132414636734
Withdrew: Lack of efficacy02111219910
Withdrew: Poor compliance to protocol0000000259
Withdrew: Not treated0000100210
Withdrew: Other than specified above0120100181521

Outcome measures

PrimaryPart A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

ACR20 response was defined, based on guidelines set forth by the American College of Rheumatology (ACR), as ≥20 % improvement in tender joint count and swollen joint count as well as ≥20% improvement in at least 3 of 5 following measures: C-Reactive Protein (CRP), Participant assessment of pain; Participant's global assessment of disease activity; Physician global assessment of disease activity; and Health Assessment Question-Disability Index (HAQ-DI). Missing data imputed by Last Observation Carried Forward (LOCF).

Time frame:
Baseline to Week 12
Reported as:
Number · Percentage of participants
Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Percentage of participantsPart A: SAR 100 mg qwPart A: SAR 150 mg qwPart A: SAR 100 mg q2wPart A: SAR 150 mg q2wPart A: SAR 200 mg q2wPart A: Placebo qw
Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1262724966.765.446.2
Statistical analysis
  • Part A: SAR 100 mg qw vs Part A: Placebo qw · Cochran-Mantel-Haenszel · p = 0.1155 (Threshold for significance = 0.05.) · Odds ratio (or): 1.99 · 95% CI 0.85 to 4.64
  • Part A: SAR 150 mg qw vs Part A: Placebo qw · Cochran-Mantel-Haenszel · p = 0.0041 (Threshold for significance = 0.05.) · Odds ratio (or): 3.84 · 95% CI 1.53 to 9.63
  • Part A: SAR 100 mg q2w vs Part A: Placebo qw · Cochran-Mantel-Haenszel · p = 0.7119 (Threshold for significance = 0.05.) · Odds ratio (or): 1.17 · 95% CI 0.52 to 2.61
  • Part A: SAR 150 mg q2w vs Part A: Placebo qw · Cochran-Mantel-Haenszel · p = 0.0363 (Threshold for significance = 0.05.) · Odds ratio (or): 2.38 · 95% CI 1.06 to 5.35
  • Part A: SAR 200 mg q2w vs Part A: Placebo qw · Cochran-Mantel-Haenszel · p = 0.0426 (Threshold for significance = 0.05.) · Odds ratio (or): 2.34 · 95% CI 1.03 to 5.29
PrimaryPart B: Percentage of Participants Achieving ACR20 Response at Week 24

ACR20 improvement responses were determined without imputation of missing post-baseline values. In addition data collected after treatment discontinuation or rescue was set to missing. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.

Time frame:
Baseline to Week 24
Reported as:
Number · Percentage of participants
Part B: Percentage of Participants Achieving ACR20 Response at Week 24
Percentage of participantsPart B: SAR 150 mg q2wPart B: SAR 200 mg q2wPart B: Placebo q2w
Part B: Percentage of Participants Achieving ACR20 Response at Week 245866.433.4
Statistical analysis
  • Part B: SAR 150 mg q2w vs Part B: Placebo q2w · Cochran-Mantel-Haenszel · p = <0.0001 (Threshold for significance = 0.025.) · Odds ratio (or): 2.773 · 95% CI 2.077 to 3.703
  • Part B: SAR 200 mg q2w vs Part B: Placebo q2w · Cochran-Mantel-Haenszel · p = <0.0001 (Threshold for significance = 0.025.) · Odds ratio (or): 3.975 · 95% CI 2.957 to 5.344
PrimaryPart B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16

HAQ-DI was a participant-reported questionnaire that assesses the difficulty of performing daily activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Overall score range from 0=least difficulty to 3=extreme difficulty. An increase in the score indicates a worsening of physical function while a decrease in the score represents improvement. Data collected after treatment discontinuation was set to missing.

Time frame:
Baseline, Week 16
Reported as:
Mean · units on a scale
Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16
units on a scalePart B: SAR 150 mg q2wPart B: SAR 200 mg q2wPart B: Placebo q2w
Baseline1.63 ± 0.631.69 ± 0.631.61 ± 0.65
Week 161.08 ± 0.671.11 ± 0.71.31 ± 0.67
Change from baseline at Week 16-0.54 ± 0.55-0.58 ± 0.63-0.3 ± 0.58
Statistical analysis
  • Part B: SAR 150 mg q2w vs Part B: Placebo q2w · Mixed Models Analysis · p = <0.0001 (Threshold for significance = 0.025.) · Ls mean difference: -0.235 · 95% CI -0.312 to -0.157
  • Part B: SAR 200 mg q2w vs Part B: Placebo q2w · Mixed Models Analysis · p = <0.0001 (Threshold for significance = 0.025.) · Ls mean difference: -0.258 · 95% CI -0.336 to -0.181
PrimaryPart B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52

The Sharp method modified by D. van der Heijde involves separate scores for erosions and joint space narrowing based on radiographs to assess the degree of structural damage. Total score range from 0 (normal) to 448 (worst possible total score). An increase in total score represents progression of structural damage. Missing data were imputed by the linear extrapolation method.

Time frame:
Baseline, Week 52
Reported as:
Mean · units on a scale
Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52
units on a scalePart B: SAR 150 mg q2wPart B: SAR 200 mg q2wPart B: Placebo q2w
Baseline54.67 ± 63.4246.34 ± 57.4348.01 ± 65.23
Week 5255.57 ± 63.7346.59 ± 57.6350.79 ± 65.82
Change from baseline at Week 520.90 ± 4.660.25 ± 4.612.78 ± 7.73
Statistical analysis
  • Part B: SAR 150 mg q2w vs Part B: Placebo q2w · Rank ANCOVA · p = <0.0001 (Threshold for significance = 0.025.)
  • Part B: SAR 200 mg q2w vs Part B: Placebo q2w · Rank ANCOVA · p = <0.0001 (Threshold for significance = 0.025.)
SecondaryPart B: Percentage of Participants Achieving a Major Clinical Response at Week 52

Major clinical response was defined as an ACR70 response maintained for at least 24 consecutive weeks. ACR70 response uses the same criteria as for ACR20 but requires 70% improvement. In the primary approach, data collected after treatment discontinuation or rescue was set to missing. No imputation of missing post-baseline values was performed. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.

Time frame:
Baseline up to Week 52
Reported as:
Number · Percentage of participants
Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52
Percentage of participantsPart B: SAR 150 mg q2wPart B: SAR 200 mg q2wPart B: Placebo q2w
Part B: Percentage of Participants Achieving a Major Clinical Response at Week 5212.814.83
Statistical analysis
  • Part B: SAR 150 mg q2w vs Part B: Placebo q2w · Cochran-Mantel-Haenszel · p = <0.0001 (Threshold for significance = 0.025.) · Odds ratio (or): 4.661 · 95% CI 2.451 to 8.863
  • Part B: SAR 200 mg q2w vs Part B: Placebo q2w · Cochran-Mantel-Haenszel · p = <0.0001 (Threshold for significance = 0.025.) · Odds ratio (or): 5.565 · 95% CI 2.946 to 10.515

Adverse events

Collected over All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Part A: SAR 100 mg qw—3/50 (6%)16/50 (32%)
Part A: SAR 150 mg qw—0/50 (0%)16/50 (32%)
Part A: SAR 100 mg q2w—3/51 (5.9%)7/51 (13.7%)
Part A: SAR 150 mg q2w—0/52 (0%)12/52 (23.1%)
Part A: SAR 200 mg q2w—0/51 (0%)19/51 (37.3%)
Part A: Placebo qw—2/51 (3.9%)11/51 (21.6%)
Part B: SAR 100 mg qw Cohort 1 (Non-selected Dose)—2/29 (6.9%)6/29 (20.7%)
Part B: SAR 150 mg qw Cohort 1 (Non-selected Dose)—2/26 (7.7%)8/26 (30.8%)
Part B: SAR 100 mg q2w Cohort 1 (Non-selected Dose)—0/29 (0%)6/29 (20.7%)
Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)—35/370 (9.5%)163/370 (44.1%)
Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)—46/369 (12.5%)194/369 (52.6%)
Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)—21/259 (8.1%)95/259 (36.7%)
Part B Sarilumab Rescue: Cohort 1(Selected Doses)+Cohort2—7/284 (2.5%)83/284 (29.2%)
Most frequent serious events
Showing 10 of 131
Most frequent serious events
EventPart A: SAR 100 mg qwPart A: SAR 150 mg qwPart A: SAR 100 mg q2wPart A: SAR 150 mg q2wPart A: SAR 200 mg q2wPart A: Placebo qwPart B: SAR 100 mg qw Cohort 1 (Non-selected Dose)Part B: SAR 150 mg qw Cohort 1 (Non-selected Dose)Part B: SAR 100 mg q2w Cohort 1 (Non-selected Dose)Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)Part B Sarilumab Rescue: Cohort 1(Selected Doses)+Cohort2
Non-cardiac chest painGeneral disorders0/500/500/510/520/510/510/291/260/290/3700/3690/2590/284
Herpes zosterInfections and infestations0/500/500/510/520/510/510/291/260/290/3701/3690/2590/284
DizzinessNervous system disorders0/500/500/510/520/510/510/291/260/290/3700/3690/2590/284
NeutropeniaBlood and lymphatic system disorders1/500/500/510/520/510/511/290/260/293/3704/3690/2590/284
Hip fractureInjury, poisoning and procedural complications0/500/500/510/520/510/511/290/260/291/3700/3690/2590/284
Alcoholic pancreatitisGastrointestinal disorders1/500/500/510/520/510/510/290/260/290/3700/3690/2590/284
HypersensitivityImmune system disorders1/500/500/510/520/510/510/290/260/290/3700/3690/2590/284
ArthralgiaMusculoskeletal and connective tissue disorders0/500/500/510/520/511/510/290/260/290/3700/3690/2590/284
Rheumatoid arthritisMusculoskeletal and connective tissue disorders0/500/501/510/520/510/510/290/260/290/3702/3691/2591/284
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/500/500/510/520/511/510/290/260/290/3700/3690/2590/284
Most frequent other events
Showing 10 of 11
Most frequent other events
EventPart A: SAR 100 mg qwPart A: SAR 150 mg qwPart A: SAR 100 mg q2wPart A: SAR 150 mg q2wPart A: SAR 200 mg q2wPart A: Placebo qwPart B: SAR 100 mg qw Cohort 1 (Non-selected Dose)Part B: SAR 150 mg qw Cohort 1 (Non-selected Dose)Part B: SAR 100 mg q2w Cohort 1 (Non-selected Dose)Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)Part B Sarilumab Rescue: Cohort 1(Selected Doses)+Cohort2
NeutropeniaBlood and lymphatic system disorders6/505/500/511/5210/510/511/292/261/2936/37055/3690/2595/284
Injection site erythemaGeneral disorders1/501/501/510/521/510/511/293/260/2920/37024/3692/25912/284
Accidental overdoseInjury, poisoning and procedural complications2/503/501/513/522/515/512/291/263/2923/37026/36917/25915/284
Upper respiratory tract infectionInfections and infestations1/502/500/512/523/512/510/291/260/2931/37035/36916/25914/284
Alanine aminotransferase increasedInvestigations2/502/500/513/522/510/510/291/260/2931/37030/36911/2599/284
HypertensionVascular disorders0/500/502/510/520/511/511/292/262/2915/37014/36910/2595/284
Rheumatoid arthritisMusculoskeletal and connective tissue disorders0/503/501/510/520/511/512/290/260/292/37010/3699/25912/284
Urinary tract infectionInfections and infestations3/500/501/511/521/511/510/290/261/2920/37022/36910/2598/284
NasopharyngitisInfections and infestations2/501/502/512/522/513/510/291/260/2920/37020/36912/25913/284
BronchitisInfections and infestations1/502/500/511/520/510/510/291/260/2912/37021/36912/2597/284

Baseline characteristics

Age, Continuous
Age, Continuous(years)Part A: SAR 100 mg qwPart A: SAR 150 mg qwPart A: SAR 100 mg q2wPart A: SAR 150 mg q2wPart A: SAR 200 mg q2wPart A: Placebo qwPart B Cohort 1: Non-selected DosesPart B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)Total
Mean53.9 ± 12.350.9 ± 11.153.5 ± 11.851.2 ± 12.948.7 ± 12.455.2 ± 12.551.1 ± 11.550.3 ± 11.950.8 ± 12.051.1 ± 11.251.04 ± 11.79
Sex: Female, Male
Sex: Female, Male(Participants)Part A: SAR 100 mg qwPart A: SAR 150 mg qwPart A: SAR 100 mg q2wPart A: SAR 150 mg q2wPart A: SAR 200 mg q2wPart A: Placebo qwPart B Cohort 1: Non-selected DosesPart B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)Total
Female414238424238693453593461362
Male98139101415856882313
08

Study locations

262 sites
  • Investigational Site Number 840070
    Anniston, Alabama 36207, United States
  • Investigational Site Number 840004
    Birmingham, Alabama 35205, United States
  • Investigational Site Number 840072
    Gilbert, Arizona 85234, United States
  • Investigational Site Number 840029
    Beverly Hills, California 90211, United States
  • Investigational Site Number 840007
    Palm Desert, California 92260, United States
  • Investigational Site Number 840008
    San Francisco, California 94143, United States
  • Investigational Site Number 840021
    Santa Maria, California 94354, United States
  • Investigational Site Number 840049
    Upland, California 91786, United States
  • Investigational Site Number 840050
    Dunedin, Florida 34698, United States
  • Investigational Site Number 840041
    Jacksonville, Florida 32209, United States
  • Investigational Site Number 840067
    Jupiter, Florida 33458, United States
  • Investigational Site Number 840048
    Miami, Florida 33155, United States
  • Investigational Site Number 840006
    Orlando, Florida 32806, United States
  • Investigational Site Number 840063
    Palm Harbor, Florida 34684, United States
  • Investigational Site Number 840060
    Sarasota, Florida 34239, United States
  • Investigational Site Number 840003
    Atlanta, Georgia 30322, United States
  • Investigational Site Number 840028
    Decatur, Georgia 30033, United States
  • Investigational Site Number 840027
    Marietta, Georgia 30060, United States
  • Investigational Site Number 840018
    Idaho Falls, Idaho 83404, United States
  • Investigational Site Number 840046
    Chicago, Illinois 60612, United States
  • Investigational Site Number 840015
    Lexington, Kentucky 40504, United States
  • Investigational Site Number 840073
    Cumberland, Maryland 21502, United States
  • Investigational Site Number 840055
    Frederick, Maryland 21702, United States
  • Investigational Site Number 840013
    Wheaton, Maryland 20902, United States
  • Investigational Site Number 840066
    Saint Louis, Missouri 63117, United States
  • Investigational Site Number 840071
    Omaha, Nebraska 68114, United States
  • Investigational Site Number 840056
    New York, New York 10016, United States
  • Investigational Site Number 840068
    Hickory, North Carolina 28601, United States
  • Investigational Site Number 840044
    Toledo, Ohio 43606, United States
  • Investigational Site Number 840002
    Oklahoma City, Oklahoma 73103, United States
  • Investigational Site Number 840011
    Tulsa, Oklahoma 74104, United States
  • Investigational Site Number 840065
    Tulsa, Oklahoma 74135, United States
  • Investigational Site Number 840010
    Bethlehem, Pennsylvania 18015, United States
  • Investigational Site Number 840009
    Duncansville, Pennsylvania 16635, United States
  • Investigational Site Number 840062
    Reading, Pennsylvania 19611, United States
  • Investigational Site Number 840058
    Columbia, South Carolina 29204, United States
  • Investigational Site Number 840016
    North Charleston, South Carolina 29406, United States
  • Investigational Site Number 840025
    Jackson, Tennessee 38305, United States
  • Investigational Site Number 840001
    Dallas, Texas 75231, United States
  • Investigational Site Number 840022
    Dallas, Texas 75235, United States
  • Investigational Site Number 840012
    Dallas, Texas 75390, United States
  • Investigational Site Number 840020
    Houston, Texas 77034, United States
  • Investigational Site Number 840069
    Lubbock, Texas 79424, United States
  • Investigational Site Number 840074
    Mesquite, Texas 75150, United States
  • Investigational Site Number 840061
    Tacoma, Washington 98405, United States
  • Investigational Site Number 032005
    Buenos Aires, 4000, Argentina
  • Investigational Site Number 032007
    Buenos Aires, Argentina
  • Investigational Site Number 032008
    Buenos Aires, Argentina
  • Investigational Site Number 032006
    Caba, C1015ABO, Argentina
  • Investigational Site Number 032002
    Cordoba, X5004BAL, Argentina
  • Investigational Site Number 032003
    Córdoba, Argentina
  • Investigational Site Number 032012
    Mar Del Plata, B7600, Argentina
  • Investigational Site Number 032011
    Quilmes, B1878DVB, Argentina
  • Investigational Site Number 032010
    Ramos Mejia, 1704, Argentina
  • Investigational Site Number 032001
    Rosario, 2000, Argentina
  • Investigational Site Number 032004
    Tucuman, 4000, Argentina
  • Investigational Site Number 032009
    Zarate, 2800, Argentina
  • Investigational Site Number 036003
    Camperdown, 2050, Australia
  • Investigational Site Number 036005
    Clayton, 3168, Australia
  • Investigational Site Number 036002
    East Malvern, 3145, Australia
  • Investigational Site Number 036012
    Fitzroy, 3065, Australia
  • Investigational Site Number 036010
    Garran, 2605, Australia
  • Investigational Site Number 036004
    Heidelberg West, 3081, Australia
  • Investigational Site Number 036009
    Herston, 4029, Australia
  • Investigational Site Number 036001
    Maroochydore, 4558, Australia
  • Investigational Site Number 036006
    St Leonards, 2065, Australia
  • Investigational Site Number 036011
    Sydney, 2035, Australia
  • Investigational Site Number 036014
    Victoria Park, 6100, Australia
  • Investigational Site Number 036007
    Woodville, 5011, Australia
  • Investigational Site Number 040001
    Graz, 8036, Austria
  • Investigational Site Number 040002
    Wien, 1100, Austria
  • Investigational Site Number 112002
    Minsk, 220037, Belarus
  • Investigational Site Number 112001
    Minsk, 220116, Belarus
  • Investigational Site Number 056003
    Genk, 3600, Belgium
  • Investigational Site Number 056001
    Liège, 4000, Belgium
  • Investigational Site Number 076008
    Campinas, 13015-001, Brazil
  • Investigational Site Number 076012
    Campinas, 13083-970, Brazil
  • Investigational Site Number 076001
    Curitiba, 80060-240, Brazil
  • Investigational Site Number 076006
    Goiania, 74110-120, Brazil
  • Investigational Site Number 076010
    Juiz De Fora, 36010-570, Brazil
  • Investigational Site Number 076004
    Porto Alegre, 90610-000, Brazil
  • Investigational Site Number 076005
    Rio De Janeiro, 20551-030, Brazil
  • Investigational Site Number 076011
    Salvador, 40050-410, Brazil
  • Investigational Site Number 076002
    Sao Paulo, 04039-901, Brazil
  • Investigational Site Number 076003
    Sao Paulo, 04230 000, Brazil
  • Investigational Site Number 076013
    Vitoria, 29055 450, Brazil
  • Investigational Site Number 124004
    Burlington, L7R 1E2, Canada
  • Investigational Site Number 124003
    Mississauga, L5M 2V8, Canada
  • Investigational Site Number 124008
    Newmarket, L3Y 3R7, Canada
  • Investigational Site Number 124002
    St. Catharines, L2N 7E4, Canada
  • Investigational Site Number 124005
    Toronto, M5T 2S8, Canada
  • Investigational Site Number 124001
    Toronto, M9R 2Y8, Canada
  • Investigational Site Number 124012
    Winnipeg, R3A 1M3, Canada
  • Investigational Site Number 152005
    Osorno, Chile
  • Investigational Site Number 152010
    Puerto Montt, Chile
  • Investigational Site Number 152012
    Santiago, 7500922, Chile
  • Investigational Site Number 152001
    Santiago, Chile
  • Investigational Site Number 152002
    Santiago, Chile
  • Investigational Site Number 152008
    Santiago, Chile
  • Investigational Site Number 152009
    Santiago, Chile

Showing the first 100 of 262 sites across 36 countries.

09

References and documents

Publications

  • Strand V, Kosinski M, Chen CI, Joseph G, Rendas-Baum R, Graham NM, van Hoogstraten H, Bayliss M, Fan C, Huizinga T, Genovese MC. Sarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trial. Arthritis Res Ther. 2016 Sep 6;18(1):198. doi: 10.1186/s13075-016-1096-9. PubMed 27600829 ↗
  • Huizinga TW, Fleischmann RM, Jasson M, Radin AR, van Adelsberg J, Fiore S, Huang X, Yancopoulos GD, Stahl N, Genovese MC. Sarilumab, a fully human monoclonal antibody against IL-6Ralpha in patients with rheumatoid arthritis and an inadequate response to methotrexate: efficacy and safety results from the randomised SARIL-RA-MOBILITY Part A trial. Ann Rheum Dis. 2014 Sep;73(9):1626-34. doi: 10.1136/annrheumdis-2013-204405. Epub 2013 Dec 2. PubMed 24297381 ↗
  • Genovese MC, Fleischmann R, Kivitz AJ, Rell-Bakalarska M, Martincova R, Fiore S, Rohane P, van Hoogstraten H, Garg A, Fan C, van Adelsberg J, Weinstein SP, Graham NM, Stahl N, Yancopoulos GD, Huizinga TW, van der Heijde D. Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase III Study. Arthritis Rheumatol. 2015 Jun;67(6):1424-37. doi: 10.1002/art.39093. PubMed 25733246 ↗
  • Rubbert-Roth A, Furst DE, Fiore S, Praestgaard A, Bykerk V, Bingham CO, Charles-Schoeman C, Burmester G. Association between low hemoglobin, clinical measures, and patient-reported outcomes in patients with rheumatoid arthritis: results from post hoc analyses of three phase III trials of sarilumab. Arthritis Res Ther. 2022 Aug 25;24(1):207. doi: 10.1186/s13075-022-02891-x. PubMed 36008838 ↗
  • Rehberg M, Giegerich C, Praestgaard A, van Hoogstraten H, Iglesias-Rodriguez M, Curtis JR, Gottenberg JE, Schwarting A, Castaneda S, Rubbert-Roth A, Choy EHS; MOBILITY, MONARCH, TARGET, and ASCERTAIN investigators. Identification of a Rule to Predict Response to Sarilumab in Patients with Rheumatoid Arthritis Using Machine Learning and Clinical Trial Data. Rheumatol Ther. 2021 Dec;8(4):1661-1675. doi: 10.1007/s40744-021-00361-5. Epub 2021 Sep 14. Erratum In: Rheumatol Ther. 2021 Dec;8(4):1921-1922. doi: 10.1007/s40744-021-00389-7. PubMed 34519964 ↗
  • Genovese MC, Burmester GR, Hagino O, Thangavelu K, Iglesias-Rodriguez M, John GS, Gonzalez-Gay MA, Mandrup-Poulsen T, Fleischmann R. Interleukin-6 receptor blockade or TNFalpha inhibition for reducing glycaemia in patients with RA and diabetes: post hoc analyses of three randomised, controlled trials. Arthritis Res Ther. 2020 Sep 9;22(1):206. doi: 10.1186/s13075-020-02229-5. PubMed 32907617 ↗
  • Genovese MC, Fleischmann R, Kivitz A, Lee EB, van Hoogstraten H, Kimura T, St John G, Mangan EK, Burmester GR. Efficacy and safety of sarilumab in combination with csDMARDs or as monotherapy in subpopulations of patients with moderately to severely active rheumatoid arthritis in three phase III randomized, controlled studies. Arthritis Res Ther. 2020 Jun 10;22(1):139. doi: 10.1186/s13075-020-02194-z. PubMed 32522251 ↗
  • Boyapati A, Schwartzman S, Msihid J, Choy E, Genovese MC, Burmester GR, Lam G, Kimura T, Sadeh J, Weinreich DM, Yancopoulos GD, Graham NMH. Association of High Serum Interleukin-6 Levels With Severe Progression of Rheumatoid Arthritis and Increased Treatment Response Differentiating Sarilumab From Adalimumab or Methotrexate in a Post Hoc Analysis. Arthritis Rheumatol. 2020 Sep;72(9):1456-1466. doi: 10.1002/art.41299. Epub 2020 Aug 25. PubMed 32343882 ↗
  • Genovese MC, van der Heijde D, Lin Y, St John G, Wang S, van Hoogstraten H, Gomez-Reino JJ, Kivitz A, Maldonado-Cocco JA, Seriolo B, Stanislav M, Burmester GR. Long-term safety and efficacy of sarilumab plus methotrexate on disease activity, physical function and radiographic progression: 5 years of sarilumab plus methotrexate treatment. RMD Open. 2019 Aug 1;5(2):e000887. doi: 10.1136/rmdopen-2018-000887. eCollection 2019. PubMed 31452928 ↗
  • Muszbek N, Proudfoot C, Fournier M, Chen CI, Kuznik A, Kiss Z, Gal P, Michaud K. Economic Evaluation of Sarilumab in the Treatment of Adult Patients with Moderately-to-Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs. Adv Ther. 2019 Jun;36(6):1337-1357. doi: 10.1007/s12325-019-00946-1. Epub 2019 Apr 19. PubMed 31004324 ↗
  • Boyapati A, Msihid J, Fiore S, van Adelsberg J, Graham NM, Hamilton JD. Sarilumab plus methotrexate suppresses circulating biomarkers of bone resorption and synovial damage in patients with rheumatoid arthritis and inadequate response to methotrexate: a biomarker study of MOBILITY. Arthritis Res Ther. 2016 Oct 6;18(1):225. doi: 10.1186/s13075-016-1132-9. PubMed 27716324 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01061736
Lead sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Feb 3, 2010
Start date
Mar 2010
Primary completion
Oct 2013
Completion
Oct 2013
Results posted
Jun 28, 2017
Last update
Jun 28, 2017

Study contacts

Mark C Genovese, MD, Professor of Medicine
principal investigator · Division of Immunology and Rheumatology - Stanford University - USA
TWJ Huizinga, Prof Dr
study chair · Dpt of Rheumatology - Leiden University Medical Center - The Netherlands

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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