An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate (RA-COMPARE)

A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients With Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment With Adalimumab and MTX

Primary Objective:

To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28).

Secondary Objectives:

To assess the signs and symptoms of RA in participants taking sarilumab in combination with MTX.

To assess the quality of life of participants with RA taking sarilumab in combination with MTX.

To assess the safety and tolerability of sarilumab in combination with MTX in participants with RA.

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Methotrexate; Drug: Adalimumab; Drug: Etanercept; Drug: Placebo (for sarilumab); Drug: Sarilumab; Drug: Placebo (for etanercept)

Detailed Description

The maximum study duration per participant enrolled in the open label run-in phase and was eligible to enroll in the randomized phase of main study was 54 weeks:

• open label screening period of up to 4 weeks
• open-label treatment period of 16 weeks
• randomized screening period of 2 to 4 weeks
• randomized treatment post-treatment safety follow-up period of 6 weeks.

The maximum study duration per participant enrolled only in the open label run-in phase and was not eligible to enroll in the randomized phase of main study was 26 weeks:

• open label screening period of up to 4 weeks
• open-label treatment period of 16 weeks
• open label treatment post-treatment safety follow-up period of 6 weeks.

The maximum study duration per participant enrolled in the open label run-in phase and was eligible to enroll in the sarilumab sub-study was 82 weeks:

• open label screening period of up to 4 weeks
• open-label treatment period of 16 weeks
• screening period of 2 to 4 weeks
• sarilumab treatment period of 52 weeks
• sub-study post-treatment safety follow-up period of 6 weeks.

• Study Type: Interventional
• Enrollment (Actual): 776
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1015ABO
    • Investigational Site Number 032052
  • Buenos Aires, Argentina, C1426AAL
    • Investigational Site Number 032050
  • La Plata, Argentina
    • Investigational Site Number 032053
  • Rosario, Argentina, S200PBJ
    • Investigational Site Number 032013
  • San Miguel De Tucumán, Argentina
    • Investigational Site Number 032051
  • Tucuman, Argentina, 4000
    • Investigational Site Number 032005
  • Zarate, Argentina, B2800DGH
    • Investigational Site Number 032009
• Australia
  • Camperdown, Australia, 2050
    • Investigational Site Number 036020
  • Heidelberg West, Australia, 3081
    • Investigational Site Number 036004
  • Victoria Park, Australia, 6100
    • Investigational Site Number 036014
  • Woodville, Australia, 5011
    • Investigational Site Number 036007
• Brazil
  • Curitiba, Brazil, 80060-240
    • Investigational Site Number 076001
  • Curitiba, Brazil
    • Investigational Site Number 076016
  • Goiania, Brazil, 74110-120
    • Investigational Site Number 076006
  • Juiz De Fora, Brazil, 36010-570
    • Investigational Site Number 076010
  • Rio De Janeiro, Brazil, 20551-030
    • Investigational Site Number 076005
  • Vitoria, Brazil, 29055 450
    • Investigational Site Number 076013
• Chile
  • Osorno, Chile, 5311092
    • Investigational Site Number 152005
  • Santiago, Chile
    • Investigational Site Number 152001
  • Santiago, Chile
    • Investigational Site Number 152002
  • Santiago, Chile
    • Investigational Site Number 152011
  • Santiago, Chile, 7510047
    • Investigational Site Number 152018
  • Temuco, Chile
    • Investigational Site Number 152015
• Colombia
  • Bogota, Colombia
    • Investigational Site Number 170001
  • Bogota, Colombia
    • Investigational Site Number 170016
  • Bogotá, Colombia, NAP
    • Investigational Site Number 170040
  • Bucaramanga, Colombia
    • Investigational Site Number 170007
  • Bucaramanga, Colombia
    • Investigational Site Number 170009
  • Medellin, Colombia
    • Investigational Site Number 170041
• Czechia
  • Ostrava, Czechia, 702 00
    • Investigational Site Number 203004
  • Praha, Czechia, 11000
    • Investigational Site Number 203032
  • Praha 2, Czechia, 12850
    • Investigational Site Number 203001
  • Praha 4, Czechia
    • Investigational Site Number 203030
  • Praha 4, Czechia, 14059
    • Investigational Site Number 203031
  • Praha 4, Czechia, 14800
    • Investigational Site Number 203033
  • Uherske Hradiste, Czechia, 686 01
    • Investigational Site Number 203002
  • Zlin, Czechia, 76001
    • Investigational Site Number 203006
• Ecuador
  • Cuenca, Ecuador
    • Investigational Site Number 218003
  • Guayaquil, Ecuador, 0593
    • Investigational Site Number 218001
  • Quito, Ecuador, 0593
    • Investigational Site Number 218002
• Finland
  • Helsinki, Finland, 00290
    • Investigational Site Number 246001
  • Hyvinkää, Finland, 05800
    • Investigational Site Number 246002
  • Oulu, Finland, 90100
    • Investigational Site Number 246030
  • Pori, Finland, 28100
    • Investigational Site Number 246003
  • Tampere, Finland
    • Investigational Site Number 246032
• France
  • Amiens Cedex 1, France, 80054
    • Investigational Site Number 250003
  • Bobigny, France
    • Investigational Site Number 250007
  • La Roche Sur Yon Cedex 9, France, 85925
    • Investigational Site Number 250001
  • Montpellier, France, 34295
    • Investigational Site Number 250002
  • Paris, France, 74014
    • Investigational Site Number 250005
  • Paris Cedex 4, France, 75181
    • Investigational Site Number 250004
  • Strasbourg, France
    • Investigational Site Number 250006
  • Toulouse, France, 31000
    • Investigational Site Number 250008
• Germany
  • Berlin, Germany, 12161
    • Investigational Site Number 276007
  • Berlin, Germany, 12161
    • Investigational Site Number 276057
  • Dresden, Germany, 01109
    • Investigational Site Number 276056
  • Dresden, Germany, 01307
    • Investigational Site Number 276055
  • Erlangen, Germany, 91056
    • Investigational Site Number 276051
  • Hamburg, Germany, 22147
    • Investigational Site Number 276013
  • Herne, Germany, 44649
    • Investigational Site Number 276001
  • Koeln, Germany
    • Investigational Site Number 276058
  • Ludwigsfelde, Germany, 14974
    • Investigational Site Number 276053
  • Rostock, Germany
    • Investigational Site Number 276050
• Greece
  • Athens, Greece, 11527
    • Investigational Site Number 300010
  • Heraklion, Greece, 71110
    • Investigational Site Number 300002
  • N. Efkarpia, Greece, 56429
    • Investigational Site Number 300014
  • Patras, Greece
    • Investigational Site Number 300012
• Hungary
  • Budapest, Hungary, 1023
    • Investigational Site Number 348001
  • Debrecen, Hungary, 4031
    • Investigational Site Number 348010
  • Esztergom, Hungary, 2500
    • Investigational Site Number 348021
  • Gy?r, Hungary, 9025
    • Investigational Site Number 348013
  • Gyula, Hungary, 5700
    • Investigational Site Number 348008
• Israel
  • Ashkelon, Israel, 78278
    • Investigational Site Number 376032
  • Haifa, Israel, 31048
    • Investigational Site Number 376001
  • Haifa, Israel, 31096
    • Investigational Site Number 376010
  • Haifa, Israel, 34362
    • Investigational Site Number 376031
  • Jerusalem, Israel, 91120
    • Investigational Site Number 376035
  • Ramat Gan, Israel, 52621
    • Investigational Site Number 376030
  • Tel Aviv, Israel, 64239
    • Investigational Site Number 376011
  • Tel Hashomer, Israel, 52621
    • Investigational Site Number 376034
• Italy
  • Firenze, Italy, 50141
    • Investigational Site Number 380002
  • Genova, Italy, 16132
    • Investigational Site Number 380005
  • Genova, Italy, 16011
    • Investigational Site Number 380004
  • L'Aquila, Italy, 67010
    • Investigational Site Number 380041
  • Valeggio Sul Mincio, Italy, 37064
    • Investigational Site Number 380042
• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Investigational Site Number 410006
  • Busan, Korea, Republic of, 602-715
    • Investigational Site Number 410020
  • Daegu, Korea, Republic of, 561-712
    • Investigational Site Number 410013
  • Daejeon, Korea, Republic of, 301-721
    • Investigational Site Number 410005
  • Jeonju, Korea, Republic of, 561-712
    • Investigational Site Number 410011
  • Seoul, Korea, Republic of, 120-752
    • Investigational Site Number 410016
  • Seoul, Korea, Republic of, 133-792
    • Investigational Site Number 410015
  • Seoul, Korea, Republic of, 135-710
    • Investigational Site Number 410022
  • Seoul, Korea, Republic of, 138-736
    • Investigational Site Number 410023
  • Seoul, Korea, Republic of, 158-710
    • Investigational Site Number 410021
  • Suwon, Korea, Republic of, 443-721
    • Investigational Site Number 410008
• Latvia
  • Liepaja, Latvia, LV-3401
    • Investigational Site Number 428002
  • Riga, Latvia, LV-1038
    • Investigational Site Number 428001
  • Ventspils, Latvia, LV 3601
    • Investigational Site Number 428003
• Lithuania
  • Kaunas, Lithuania, LT-50009
    • Investigational Site Number 440005
  • Klaipeda, Lithuania, LT-92288
    • Investigational Site Number 440006
  • Panevezys, Lithuania, LT- 35144
    • Investigational Site Number 440010
  • Vilnius, Lithuania, 08661
    • Investigational Site Number 440011
• Malaysia
  • Batu Caves, Malaysia, 68100
    • Investigational Site Number 458012
  • Georgetown, Malaysia, 10990
    • Investigational Site Number 458014
  • Ipoh, Malaysia, 30990
    • Investigational Site Number 458001
  • Kota Bharu, Malaysia, 15586
    • Investigational Site Number 458013
  • Kuching, Malaysia, 93586
    • Investigational Site Number 458002
  • Melaka, Malaysia, 75400
    • Investigational Site Number 458010
  • Seremban, Malaysia, 70300
    • Investigational Site Number 458011
• Mexico
  • Cd. Obregon, Mexico
    • Investigational Site Number 484027
  • Chihuahua, Mexico, 31020
    • Investigational Site Number 484023
  • Deleg. Benito Juárez, Mexico, 3100
    • Investigational Site Number 484029
  • Guadalajara, Mexico, 44620
    • Investigational Site Number 484018
  • Guadalajara, Mexico, 44158
    • Investigational Site Number 484013
  • Merida, Mexico, 97000
    • Investigational Site Number 484004
  • Mexicali, Mexico, 21200
    • Investigational Site Number 484010
  • Mexicali, Mexico, 21200
    • Investigational Site Number 484026
  • Mexico City, Mexico, 6726
    • Investigational Site Number 484052
  • México, Mexico, 06700
    • Investigational Site Number 484017
  • San Luis, Mexico, 78220
    • Investigational Site Number 484025
  • Tijuana, Mexico, 22010
    • Investigational Site Number 484051
• New Zealand
  • Auckland, New Zealand, 1023
    • Investigational Site Number 554007
  • Dunedin, New Zealand, 9016
    • Investigational Site Number 554010
  • Hamilton, New Zealand, 3204
    • Investigational Site Number 554005
  • Nelson, New Zealand, 1023
    • Investigational Site Number 554011
• Peru
  • Lima, Peru, 021
    • Investigational Site Number 604001
  • Lima, Peru, 14
    • Investigational Site Number 604010
  • Lima, Peru, LIMA 01
    • Investigational Site Number 604009
  • Lima, Peru, LIMA 11
    • Investigational Site Number 604012
  • Lima, Peru, Lima 33
    • Investigational Site Number 604007
  • Lima, Peru, Lima 41
    • Investigational Site Number 604005
  • Lima, Peru, Lima36
    • Investigational Site Number 604020
• Poland
  • Bydgoszcz, Poland, 85-168
    • Investigational Site Number 616019
  • Bytom, Poland, 41-902
    • Investigational Site Number 616054
  • Dzialdowo, Poland, 13-200
    • Investigational Site Number 616052
  • Elblag, Poland
    • Investigational Site Number 616015
  • Krakow, Poland, 31-121
    • Investigational Site Number 616057
  • Krakow, Poland, 31-209
    • Investigational Site Number 616059
  • Krakow, Poland
    • Investigational Site Number 616061
  • Lublin, Poland, 20-607
    • Investigational Site Number 616005
  • Myslenice, Poland, 32-400
    • Investigational Site Number 616063
  • Poznan, Poland, 61-397
    • Investigational Site Number 616018
  • Sosnowiec, Poland, 41-200
    • Investigational Site Number 616013
  • Starachowice, Poland, 27-200
    • Investigational Site Number 616056
  • Szczecin, Poland, 71-252
    • Investigational Site Number 616016
  • Ustron, Poland, 43-450
    • Investigational Site Number 616058
  • Warszawa, Poland, 02-653
    • Investigational Site Number 616051
  • Zyrardow, Poland, 96-300
    • Investigational Site Number 616053
• Romania
  • Bacau, Romania
    • Investigational Site Number 642041
  • Bucharest, Romania
    • Investigational Site Number 642004
  • Bucharest, Romania, 400006
    • Investigational Site Number 642012
  • Bucharest, Romania
    • Investigational Site Number 642023
  • Bucuresti, Romania, 010976
    • Investigational Site Number 642001
  • Bucuresti, Romania, 020983
    • Investigational Site Number 642002
  • Bucuresti, Romania, 020125
    • Investigational Site Number 642040
  • Bucuresti, Romania
    • Investigational Site Number 642042
  • Galati, Romania, 800578
    • Investigational Site Number 642005
  • Iasi, Romania, 700127
    • Investigational Site Number 642013
  • Iasi, Romania, 700656
    • Investigational Site Number 642014
  • Targoviste, Romania, 130083
    • Investigational Site Number 642022
• Russian Federation
  • Kemerovo, Russian Federation, 650099
    • Investigational Site Number 643006
  • Krasnoyarsk, Russian Federation, 660022
    • Investigational Site Number 643056
  • Moscow, Russian Federation, 119049
    • Investigational Site Number 643021
  • Moscow, Russian Federation, 121374
    • Investigational Site Number 643031
  • Moscow, Russian Federation, 125284
    • Investigational Site Number 643030
  • Moscow, Russian Federation, 117556
    • Investigational Site Number 643052
  • Novosibirsk, Russian Federation, 630091
    • Investigational Site Number 643022
  • Samara, Russian Federation, 443095
    • Investigational Site Number 643010
  • Saratov, Russian Federation, 410012
    • Investigational Site Number 643011
  • Smolensk, Russian Federation, 214019
    • Investigational Site Number 643059
  • St-Petersburg, Russian Federation, 192242
    • Investigational Site Number 643008
  • St. Peterburg, Russian Federation
    • Investigational Site Number 643058
  • Ufa, Russian Federation, 450005
    • Investigational Site Number 643013
  • Voronezh, Russian Federation
    • Investigational Site Number 643050
  • Yaroslavl, Russian Federation, 150003
    • Investigational Site Number 643057
  • Yaroslavl, Russian Federation
    • Investigational Site Number 643051
• South Africa
  • Cape Town, South Africa, 7405
    • Investigational Site Number 710011
  • Cape Town, South Africa, 7500
    • Investigational Site Number 710007
  • Pretoria, South Africa, 0182
    • Investigational Site Number 710006
  • Pretoria, South Africa, 0002
    • Investigational Site Number 710008
  • Stellenbsoch, South Africa, 7600
    • Investigational Site Number 710010
• Spain
  • Córdoba, Spain, 14004
    • Investigational Site Number 724043
  • La Coruña, Spain, 15006
    • Investigational Site Number 724009
  • Madrid, Spain, 28034
    • Investigational Site Number 724042
  • Madrid, Spain, 28046
    • Investigational Site Number 724041
  • Madrid, Spain, 28850
    • Investigational Site Number 724040
  • Málaga, Spain, 29009
    • Investigational Site Number 724001
  • Sabadell, Spain, 08208
    • Investigational Site Number 724011
  • Santiago De Compostela, Spain, 15705
    • Investigational Site Number 724012
• Taiwan
  • Changhua, Taiwan, 500
    • Investigational Site Number 158010
  • Chia-Yi, Taiwan, 622
    • Investigational Site Number 158004
  • Kaohsiung, Taiwan, 807
    • Investigational Site Number 158012
  • Kaohsiung, Taiwan, 833
    • Investigational Site Number 158011
  • Taipei, Taiwan, 402
    • Investigational Site Number 158006
• Thailand
  • Bangkok, Thailand, 10330
    • Investigational Site Number 764002
  • Bangkok, Thailand, 10400
    • Investigational Site Number 764010
  • Bangkok-Noi, Thailand
    • Investigational Site Number 764003
  • Khon Kaen, Thailand, 40002
    • Investigational Site Number 764011
• Ukraine
  • Dnipropetrovsk, Ukraine, 49008
    • Investigational Site Number 804003
  • Donetsk, Ukraine, 83114
    • Investigational Site Number 804002
  • Donetsk, Ukraine
    • Investigational Site Number 804024
  • Ivano-Frankivsk, Ukraine, 76018
    • Investigational Site Number 804029
  • Kharkiv, Ukraine, 61022
    • Investigational Site Number 804010
  • Kharkov, Ukraine, 61057
    • Investigational Site Number 804001
  • Kiev, Ukraine, 04114
    • Investigational Site Number 804025
  • Kyiv, Ukraine, 01103
    • Investigational Site Number 804014
  • Kyiv, Ukraine, 03680
    • Investigational Site Number 804027
  • Kyiv, Ukraine, 01023
    • Investigational Site Number 804023
  • Kyiv, Ukraine
    • Investigational Site Number 804011
  • Lutsk, Ukraine, 43024
    • Investigational Site Number 804030
  • Lviv, Ukraine, 79005
    • Investigational Site Number 804005
  • Lviv, Ukraine, 79010
    • Investigational Site Number 804033
  • Lviv, Ukraine, 79013
    • Investigational Site Number 804020
  • Odesa, Ukraine, 65025
    • Investigational Site Number 804032
  • Odesa, Ukraine, 65026
    • Investigational Site Number 804022
  • Odessa, Ukraine, 65117
    • Investigational Site Number 804012
  • Simferopol, Ukraine, 95017
    • Investigational Site Number 804021
  • Zaporozhye, Ukraine, 69118
    • Investigational Site Number 804028
  • Zhytomyr, Ukraine
    • Investigational Site Number 804031
• United Kingdom
  • Barnsley, United Kingdom
    • Investigational Site Number 826023
  • Birmingham, United Kingdom, B15 2TH
    • Investigational Site Number 826022
  • Dudley, United Kingdom, DY1 2HQ
    • Investigational Site Number 826021
  • Durham, United Kingdom
    • Investigational Site Number 826026
  • Durham, United Kingdom
    • Investigational Site Number 826027
  • Harlow, United Kingdom, CM20 1QX
    • Investigational Site Number 826020
  • Wigan, United Kingdom, WN6 9EP
    • Investigational Site Number 826025
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Investigational Site Number 840004
  • California
    • Glendale, California, United States, 91205
      • Investigational Site Number 840212
    • Thousand Oaks, California, United States, 91360
      • Investigational Site Number 840211
    • Upland, California, United States, 91786
      • Investigational Site Number 840049
    • Victorville, California, United States, 92395
      • Investigational Site Number 840205
  • Colorado
    • Denver, Colorado, United States, 80230
      • Investigational Site Number 840201
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Investigational Site Number 840209
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20003
      • Investigational Site Number 840203
  • Florida
    • Clearwater, Florida, United States, 33756
      • Investigational Site Number 840210
    • Ormond Beach, Florida, United States, 32174
      • Investigational Site Number 840128
    • Palm Harbor, Florida, United States, 34684
      • Investigational Site Number 840063
    • Sarasota, Florida, United States, 34239
      • Investigational Site Number 840060
    • Tampa, Florida, United States, 33612
      • Investigational Site Number 840207
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Investigational Site Number 840018
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Investigational Site Number 840213
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Investigational Site Number 840109
  • Maryland
    • Cumberland, Maryland, United States, 21502
      • Investigational Site Number 840073
    • Hagerstown, Maryland, United States, 21740
      • Investigational Site Number 840202
  • Michigan
    • Battle Creek, Michigan, United States, 49015
      • Investigational Site Number 840204
    • Lansing, Michigan, United States, 48910
      • Investigational Site Number 840150
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Investigational Site Number 840200
    • Tupelo, Mississippi, United States, 38801
      • Investigational Site Number 840037
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Investigational Site Number 840112
  • New York
    • New York, New York, United States, 10016
      • Investigational Site Number 840056
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • Investigational Site Number 840117
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Investigational Site Number 840016
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Investigational Site Number 840025
  • Texas
    • Mesquite, Texas, United States, 75150
      • Investigational Site Number 840074
  • Washington
    • Tacoma, Washington, United States, 98405
      • Investigational Site Number 840061
  • West Virginia
    • Clarksburg, West Virginia, United States, 26301
      • Investigational Site Number 840124

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Diagnosis of RA >/= 3 months duration.
• Continuous treatment of MTX 10 - 25 mg/week (or per local labeling requirements if the dose range differs) for at least 12 weeks before screening visit and on a stable dose for 8 weeks before screening visit.
• Active disease defined as: at least 6/66 swollen and 8/68 tender joints and high sensitivity C-reactive protein > 10 mg/L.

Exclusion criteria:

• Age < 18 years.
• Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks of the screening visit.
• Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks of the screening visit.
• Prior treatment with a tumor necrosis factor (TNF)-alpha inhibitor, or other biological disease modifying anti-rheumatoid drug (DMARD) or Janus Kinase inhibitor.
• New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors within 4 weeks of the screening visit.
• Treatment with traditional oral DMARD /immunosuppressive agents other than MTX within 4 weeks or 12 weeks before the screening visit, depending on DMARD.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Adalimumab Open Label run-in; Adalimumab 40 mg every 2 weeks (Q2W) for 16 weeks added to stable dose of MTX.	Drug: Methotrexate; Dispensed according to local practice.; Drug: Adalimumab; Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
ACTIVE_COMPARATOR: Etanercept + MTX (Randomized); Etanercept 50 mg in combination with Placebo for sarilumab Q2W and etanercept 50 mg on alternating weeks for 24 weeks added to stable dose of MTX.	Drug: Methotrexate; Dispensed according to local practice.; Drug: Etanercept; Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous; Other Names: Enbrel; Drug: Placebo (for sarilumab)
EXPERIMENTAL: Sarilumab 150 mg + MTX (Randomized); Sarilumab 150 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.	Drug: Methotrexate; Dispensed according to local practice.; Drug: Sarilumab; Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous; Other Names: SAR153191; REGN88; Drug: Placebo (for etanercept)
EXPERIMENTAL: Sarilumab 200 mg + MTX (Randomized); Sarilumab 200 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.	Drug: Methotrexate; Dispensed according to local practice.; Drug: Sarilumab; Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous; Other Names: SAR153191; REGN88; Drug: Placebo (for etanercept)
EXPERIMENTAL: Sarilumab 150 mg + MTX Open Label Sub-study; Sarilumab 150 mg Q2W for 52 weeks added to stable dose of MTX.	Drug: Methotrexate; Dispensed according to local practice.; Drug: Sarilumab; Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous; Other Names: SAR153191; REGN88

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Disease Activity Score for 28 Joints - C-Reactive Protein (DAS28-CRP) Score at Week 24	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With at Least 20% Improvement in American College of Rheumatology (ACR20), at Least 50% Improvement in ACR (ACR50) and at Least 70% Improvement in ACR (ACR70) Efficacy Response Rates at Week 12 and Week 24	Week 12 and Week 24
Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 12 and Week 24	Week 12 and Week 24
Change From Baseline in DAS28-CRP Score at Week 12	Baseline, Week 12

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: January 8, 2013
• First Submitted That Met QC Criteria: January 9, 2013
• First Posted (ESTIMATE): January 10, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Etanercept; Adalimumab; Methotrexate
• Other Study ID Numbers: EFC11574; 2012-001984-66; U1111-1131-6653 (OTHER: UTN)