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

June 27, 2017 updated by: Sanofi

A Randomized, Double-blind, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

1675

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 4000
        • Investigational Site Number 032005
      • Buenos Aires, Argentina
        • Investigational Site Number 032007
      • Buenos Aires, Argentina
        • Investigational Site Number 032008
      • Caba, Argentina, C1015ABO
        • Investigational Site Number 032006
      • Cordoba, Argentina, X5004BAL
        • Investigational Site Number 032002
      • Córdoba, Argentina
        • Investigational Site Number 032003
      • Mar Del Plata, Argentina, B7600
        • Investigational Site Number 032012
      • Quilmes, Argentina, B1878DVB
        • Investigational Site Number 032011
      • Ramos Mejia, Argentina, 1704
        • Investigational Site Number 032010
      • Rosario, Argentina, 2000
        • Investigational Site Number 032001
      • Tucuman, Argentina, 4000
        • Investigational Site Number 032004
      • Zarate, Argentina, 2800
        • Investigational Site Number 032009
  • Australia
      • Camperdown, Australia, 2050
        • Investigational Site Number 036003
      • Clayton, Australia, 3168
        • Investigational Site Number 036005
      • East Malvern, Australia, 3145
        • Investigational Site Number 036002
      • Fitzroy, Australia, 3065
        • Investigational Site Number 036012
      • Garran, Australia, 2605
        • Investigational Site Number 036010
      • Heidelberg West, Australia, 3081
        • Investigational Site Number 036004
      • Herston, Australia, 4029
        • Investigational Site Number 036009
      • Maroochydore, Australia, 4558
        • Investigational Site Number 036001
      • St Leonards, Australia, 2065
        • Investigational Site Number 036006
      • Sydney, Australia, 2035
        • Investigational Site Number 036011
      • Victoria Park, Australia, 6100
        • Investigational Site Number 036014
      • Woodville, Australia, 5011
        • Investigational Site Number 036007
  • Austria
      • Graz, Austria, 8036
        • Investigational Site Number 040001
      • Wien, Austria, 1100
        • Investigational Site Number 040002
  • Belarus
      • Minsk, Belarus, 220037
        • Investigational Site Number 112002
      • Minsk, Belarus, 220116
        • Investigational Site Number 112001
  • Belgium
      • Genk, Belgium, 3600
        • Investigational Site Number 056003
      • Liège, Belgium, 4000
        • Investigational Site Number 056001
  • Brazil
      • Campinas, Brazil, 13015-001
        • Investigational Site Number 076008
      • Campinas, Brazil, 13083-970
        • Investigational Site Number 076012
      • Curitiba, Brazil, 80060-240
        • Investigational Site Number 076001
      • Goiania, Brazil, 74110-120
        • Investigational Site Number 076006
      • Juiz De Fora, Brazil, 36010-570
        • Investigational Site Number 076010
      • Porto Alegre, Brazil, 90610-000
        • Investigational Site Number 076004
      • Rio De Janeiro, Brazil, 20551-030
        • Investigational Site Number 076005
      • Salvador, Brazil, 40050-410
        • Investigational Site Number 076011
      • Sao Paulo, Brazil, 04039-901
        • Investigational Site Number 076002
      • Sao Paulo, Brazil, 04230 000
        • Investigational Site Number 076003
      • Vitoria, Brazil, 29055 450
        • Investigational Site Number 076013
  • Canada
      • Burlington, Canada, L7R 1E2
        • Investigational Site Number 124004
      • Mississauga, Canada, L5M 2V8
        • Investigational Site Number 124003
      • Newmarket, Canada, L3Y 3R7
        • Investigational Site Number 124008
      • St. Catharines, Canada, L2N 7E4
        • Investigational Site Number 124002
      • Toronto, Canada, M5T 2S8
        • Investigational Site Number 124005
      • Toronto, Canada, M9R 2Y8
        • Investigational Site Number 124001
      • Winnipeg, Canada, R3A 1M3
        • Investigational Site Number 124012
  • Chile
      • Osorno, Chile
        • Investigational Site Number 152005
      • Puerto Montt, Chile
        • Investigational Site Number 152010
      • Santiago, Chile, 7500922
        • Investigational Site Number 152012
      • Santiago, Chile
        • Investigational Site Number 152008
      • Santiago, Chile
        • Investigational Site Number 152001
      • Santiago, Chile
        • Investigational Site Number 152002
      • Santiago, Chile
        • Investigational Site Number 152009
      • Santiago, Chile
        • Investigational Site Number 152011
      • Santiago, Chile
        • Investigational Site Number 152013
      • Talca, Chile, 3460000
        • Investigational Site Number 152014
      • Valdivia, Chile
        • Investigational Site Number 152004
      • Vina Del Mar, Chile
        • Investigational Site Number 152006
      • Viña Del Mar, Chile, 2570017
        • Investigational Site Number 152007
  • Colombia
      • Barranquilla, Colombia
        • Investigational Site Number 170004
      • Bogota, Colombia
        • Investigational Site Number 170001
      • Bogota, Colombia
        • Investigational Site Number 170008
      • Bogotá, Colombia
        • Investigational Site Number 170006
      • Bogotá, Colombia
        • Investigational Site Number 170003
      • Bucaramanga, Colombia
        • Investigational Site Number 170007
      • Bucaramanga, Colombia
        • Investigational Site Number 170009
      • Medellin, Colombia
        • Investigational Site Number 170002
  • Czechia
      • Brno, Czechia, 63801
        • Investigational Site Number 203005
      • Hlucin, Czechia, 74801
        • Investigational Site Number 203004
      • Praha 2, Czechia, 12850
        • Investigational Site Number 203001
      • Uherske Hradiste, Czechia, 68601
        • Investigational Site Number 203002
  • Egypt
      • Cairo, Egypt
        • Investigational Site Number 818001
      • Cairo, Egypt
        • Investigational Site Number 818002
  • Estonia
      • Tallinn, Estonia, 10128
        • Investigational Site Number 233001
      • Tallinn, Estonia, 13419
        • Investigational Site Number 233002
  • Finland
      • Helsinki, Finland, 00290
        • Investigational Site Number 246001
      • Hyvinkää, Finland, 05800
        • Investigational Site Number 246002
      • Pori, Finland, 28100
        • Investigational Site Number 246003
  • Germany
      • Berlin, Germany, 12161
        • Investigational Site Number 276007
      • Berlin, Germany, 12161
        • Investigational Site Number 276008
      • Erlangen, Germany, 91054
        • Investigational Site Number 276004
      • Frankfurt Am Main, Germany, 60590
        • Investigational Site Number 276003
      • Halle/Saale, Germany, 06108
        • Investigational Site Number 276015
      • Hamburg, Germany, 22081
        • Investigational Site Number 276005
      • Hamburg, Germany, 22147
        • Investigational Site Number 276013
      • Heidelberg, Germany, 69120
        • Investigational Site Number 276012
      • Herne, Germany, 44652
        • Investigational Site Number 276001
      • Hildesheim, Germany, 31134
        • Investigational Site Number 276006
  • Greece
      • Athens, Greece, 11527
        • Investigational Site Number 300001
      • Heraklion, Greece, 71110
        • Investigational Site Number 300002
      • Thessaloniki, Greece, 546 36
        • Investigational Site Number 300003
  • Hungary
      • Budapest, Hungary, 1023
        • Investigational Site Number 348006
      • Budapest, Hungary, 1027
        • Investigational Site Number 348014
      • Debrecen, Hungary, 4032
        • Investigational Site Number 348003
      • Debrecen, Hungary, 4043
        • Investigational Site Number 348010
      • Eger, Hungary, 3300
        • Investigational Site Number 348011
      • Gy?r, Hungary, 9025
        • Investigational Site Number 348013
      • Szombathely, Hungary, H-9700
        • Investigational Site Number 348015
      • Sátoraljaújhely, Hungary, 3980
        • Investigational Site Number 348005
      • Veszprém, Hungary, 8200
        • Investigational Site Number 348004
  • India
      • Ahmedabad, India, 380009
        • Investigational Site Number 356015
      • Bangalore, India, 560079
        • Investigational Site Number 356007
      • Chennai, India, 600004
        • Investigational Site Number 356003
      • Hyderabad, India, 500003
        • Investigational Site Number 356012
      • Hyderabad, India, 500004
        • Investigational Site Number 356005
      • Lucknow, India, 226003
        • Investigational Site Number 356011
      • Lucknow, India, 226014
        • Investigational Site Number 356013
      • Maharashtra, India, 411 001
        • Investigational Site Number 356001
      • Mumbai, India, 400008
        • Investigational Site Number 356010
      • Mumbai, India, 400012
        • Investigational Site Number 356004
      • New Delhi, India, 122001
        • Investigational Site Number 356002
      • New Delhi, India, 76
        • Investigational Site Number 356008
  • Korea, Republic of
      • Anyang, Korea, Republic of, 431-070
        • Investigational Site Number 410014
      • Busan, Korea, Republic of, 602-739
        • Investigational Site Number 410006
      • Daegu, Korea, Republic of, 700-721
        • Investigational Site Number 410004
      • Daegu, Korea, Republic of, 705-718
        • Investigational Site Number 410013
      • Daejeon, Korea, Republic of, 302-799
        • Investigational Site Number 410005
      • Gwangju, Korea, Republic of, 501-757
        • Investigational Site Number 410010
      • Incheon, Korea, Republic of, 400-711
        • Investigational Site Number 410009
      • Incheon, Korea, Republic of
        • Investigational Site Number 410001
      • Jeonju, Korea, Republic of, 561-712
        • Investigational Site Number 410011
      • Seoul, Korea, Republic of, 150-713
        • Investigational Site Number 410003
      • Seoul, Korea, Republic of, 110-744
        • Investigational Site Number 410007
      • Seoul, Korea, Republic of, 133-792
        • Investigational Site Number 410012
      • Seoul, Korea, Republic of
        • Investigational Site Number 410002
      • Suwon, Korea, Republic of, 443-721
        • Investigational Site Number 410008
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • Investigational Site Number 440001
      • Vilnius, Lithuania, LT-08661
        • Investigational Site Number 440002
  • Malaysia
      • Ipoh, Malaysia, 30990
        • Investigational Site Number 458001
      • Kuching, Malaysia, 93586
        • Investigational Site Number 458002
      • Putrajaya, Malaysia
        • Investigational Site Number 458003
  • Mexico
      • Durango, Mexico, 34270
        • Investigational Site Number 484008
      • Guadalajara, Mexico, 44690
        • Investigational Site Number 484002
      • Merida, Mexico, 97000
        • Investigational Site Number 484009
      • Merida, Mexico, 97000
        • Investigational Site Number 484004
      • Metepec, Mexico, 52140
        • Investigational Site Number 484007
      • Mexico City, Mexico, 6726
        • Investigational Site Number 484003
      • Mexico, D.F., Mexico, 11850
        • Investigational Site Number 484001
      • Monterrey, Mexico, 64000
        • Investigational Site Number 484005
  • Netherlands
      • Heerlen, Netherlands, 6419 PC
        • Investigational Site Number 528002
  • New Zealand
      • Christchurch, New Zealand, 8002
        • Investigational Site Number 554004
      • Rotorua, New Zealand
        • Investigational Site Number 554002
      • Tauranga, New Zealand, 3001
        • Investigational Site Number 554003
      • Timaru, New Zealand
        • Investigational Site Number 554001
  • Norway
      • Kristiansand, Norway, 4604
        • Investigational Site Number 578004
      • Tønsberg, Norway, 3105
        • Investigational Site Number 578006
  • Philippines
      • Cebu City, Philippines, 6000
        • Investigational Site Number 608003
      • Manila, Philippines, 1008
        • Investigational Site Number 608001
      • Manila, Philippines
        • Investigational Site Number 608002
  • Poland
      • Bialystok, Poland, 15-354
        • Investigational Site Number 616002
      • Bialystok, Poland, 15-461
        • Investigational Site Number 616003
      • Krakow, Poland, 30-510
        • Investigational Site Number 616001
      • Lublin, Poland, 20-607
        • Investigational Site Number 616005
      • Torun, Poland, 87-100
        • Investigational Site Number 616006
      • Warszawa, Poland, 02-118
        • Investigational Site Number 616004
      • Wroclaw, Poland, 50-044
        • Investigational Site Number 616012
  • Portugal
      • Aveiro, Portugal, 3814-501
        • Investigational Site Number 620003
      • Lisboa, Portugal, 1649-035
        • Investigational Site Number 620001
      • Lisboa, Portugal
        • Investigational Site Number 620002
  • Romania
      • Braila, Romania, 810019
        • Investigational Site Number 642006
      • Bucharest, Romania
        • Investigational Site Number 642004
      • Bucharest, Romania
        • Investigational Site Number 642010
      • Bucuresti, Romania, 010976
        • Investigational Site Number 642001
      • Bucuresti, Romania, 020983
        • Investigational Site Number 642002
      • Bucuresti, Romania, 400347
        • Investigational Site Number 642003
      • Galati, Romania, 800578
        • Investigational Site Number 642005
      • Ploiesti, Romania
        • Investigational Site Number 642008
  • Russian Federation
      • Kemerovo, Russian Federation, 650066
        • Investigational Site Number 643017
      • Kemerovo, Russian Federation, 650099
        • Investigational Site Number 643006
      • Moscow, Russian Federation, 115404
        • Investigational Site Number 643020
      • Moscow, Russian Federation, 115522
        • Investigational Site Number 643001
      • Moscow, Russian Federation, 117997
        • Investigational Site Number 643002
      • Moscow, Russian Federation, 121359
        • Investigational Site Number 643012
      • Moscow, Russian Federation, 107014
        • Investigational Site Number 643004
      • Novosibirsk, Russian Federation, 630099
        • Investigational Site Number 643009
      • Ryazan, Russian Federation, 390026
        • Investigational Site Number 643016
      • Saint-Petersburg, Russian Federation, 196247
        • Investigational Site Number 643014
      • Samara, Russian Federation, 443095
        • Investigational Site Number 643010
      • Saratov, Russian Federation, 410053
        • Investigational Site Number 643011
      • St-Petersburg, Russian Federation, 190068
        • Investigational Site Number 643007
      • St-Petersburg, Russian Federation, 192242
        • Investigational Site Number 643008
      • Ufa, Russian Federation, 450005
        • Investigational Site Number 643013
  • South Africa
      • Cape Town, South Africa, 7405
        • Investigational Site Number 710011
      • Cape Town, South Africa, 8001
        • Investigational Site Number 710009
      • Cape Town, South Africa, 7530
        • Investigational Site Number 710007
      • Durban, South Africa, 4001
        • Investigational Site Number 710003
      • Durban, South Africa, 4091
        • Investigational Site Number 710002
      • Johannesburg, South Africa, 2013
        • Investigational Site Number 710001
      • Kempton Park, South Africa, 1619
        • Investigational Site Number 710004
      • Pretoria, South Africa, 0075
        • Investigational Site Number 710005
      • Pretoria, South Africa, 0182
        • Investigational Site Number 710006
      • Pretoria, South Africa
        • Investigational Site Number 710008
      • Stellenbosch, South Africa, 7600
        • Investigational Site Number 710010
  • Spain
      • Barcelona, Spain, 08025
        • Investigational Site Number 724010
      • La Coruña, Spain, 15006
        • Investigational Site Number 724009
      • Sabadell, Spain, 08208
        • Investigational Site Number 724011
      • Santiago De Compostela, Spain, 15705
        • Investigational Site Number 724012
      • Sevilla, Spain, 41008
        • Investigational Site Number 724007
  • Taiwan
      • Linkou, Taiwan, 333
        • Investigational Site Number 158002
      • Taipei, Taiwan, 100
        • Investigational Site Number 158001
  • Thailand
      • Bangkok, Thailand, 10400
        • Investigational Site Number 764001
      • Bangkok, Thailand, 10700
        • Investigational Site Number 764003
  • Turkey
      • Adana, Turkey, 01330
        • Investigational Site Number 792003
      • Ankara, Turkey, 06100
        • Investigational Site Number 792002
      • Ankara, Turkey
        • Investigational Site Number 792005
      • Antalya, Turkey, 07059
        • Investigational Site Number 792004
      • Izmir, Turkey, 35340
        • Investigational Site Number 792001
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49008
        • Investigational Site Number 804003
      • Donetsk, Ukraine, 83114
        • Investigational Site Number 804002
      • Kharkov, Ukraine, 61022
        • Investigational Site Number 804010
      • Kyiv, Ukraine, 01023
        • Investigational Site Number 804008
      • Kyiv, Ukraine, 03151
        • Investigational Site Number 804004
      • Lviv, Ukraine, 79005
        • Investigational Site Number 804005
      • Simferopol, Ukraine, 95017
        • Investigational Site Number 804006
      • Zaporizhzhia, Ukraine, 69600
        • Investigational Site Number 804009
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Investigational Site Number 840070
      • Birmingham, Alabama, United States, 35205
        • Investigational Site Number 840004
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Investigational Site Number 840072
    • California
      • Beverly Hills, California, United States, 90211
        • Investigational Site Number 840029
      • Palm Desert, California, United States, 92260
        • Investigational Site Number 840007
      • San Francisco, California, United States, 94143
        • Investigational Site Number 840008
      • Santa Maria, California, United States, 94354
        • Investigational Site Number 840021
      • Upland, California, United States, 91786
        • Investigational Site Number 840049
    • Florida
      • Dunedin, Florida, United States, 34698
        • Investigational Site Number 840050
      • Jacksonville, Florida, United States, 32209
        • Investigational Site Number 840041
      • Jupiter, Florida, United States, 33458
        • Investigational Site Number 840067
      • Miami, Florida, United States, 33155
        • Investigational Site Number 840048
      • Orlando, Florida, United States, 32806
        • Investigational Site Number 840006
      • Palm Harbor, Florida, United States, 34684
        • Investigational Site Number 840063
      • Sarasota, Florida, United States, 34239
        • Investigational Site Number 840060
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Investigational Site Number 840003
      • Decatur, Georgia, United States, 30033
        • Investigational Site Number 840028
      • Marietta, Georgia, United States, 30060
        • Investigational Site Number 840027
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Investigational Site Number 840018
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Investigational Site Number 840046
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Investigational Site Number 840015
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Investigational Site Number 840073
      • Frederick, Maryland, United States, 21702
        • Investigational Site Number 840055
      • Wheaton, Maryland, United States, 20902
        • Investigational Site Number 840013
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Investigational Site Number 840066
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Investigational Site Number 840071
    • New York
      • New York, New York, United States, 10016
        • Investigational Site Number 840056
    • North Carolina
      • Hickory, North Carolina, United States, 28601
        • Investigational Site Number 840068
    • Ohio
      • Toledo, Ohio, United States, 43606
        • Investigational Site Number 840044
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Investigational Site Number 840002
      • Tulsa, Oklahoma, United States, 74104
        • Investigational Site Number 840011
      • Tulsa, Oklahoma, United States, 74135
        • Investigational Site Number 840065
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Investigational Site Number 840010
      • Duncansville, Pennsylvania, United States, 16635
        • Investigational Site Number 840009
      • Reading, Pennsylvania, United States, 19611
        • Investigational Site Number 840062
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Investigational Site Number 840058
      • North Charleston, South Carolina, United States, 29406
        • Investigational Site Number 840016
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Investigational Site Number 840025
    • Texas
      • Dallas, Texas, United States, 75231
        • Investigational Site Number 840001
      • Dallas, Texas, United States, 75235
        • Investigational Site Number 840022
      • Dallas, Texas, United States, 75390
        • Investigational Site Number 840012
      • Houston, Texas, United States, 77034
        • Investigational Site Number 840020
      • Lubbock, Texas, United States, 79424
        • Investigational Site Number 840069
      • Mesquite, Texas, United States, 75150
        • Investigational Site Number 840074
    • Washington
      • Tacoma, Washington, United States, 98405
        • Investigational Site Number 840061

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: SAR 100 mg qw
Sarilumab 100 mg subcutaneous (SC) injection weekly (qw) on top of MTX for 12 weeks.
Drug: Sarilumab

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR153191
  • REGN88
Drug: Methotrexate
Same weekly dose as received prior to enrollment
Drug: Folic Acid
According to local standard
Experimental: Part A: SAR 150 mg qw
Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
Drug: Sarilumab

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR153191
  • REGN88
Drug: Methotrexate
Same weekly dose as received prior to enrollment
Drug: Folic Acid
According to local standard
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

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR153191
  • REGN88
Drug: Methotrexate
Same weekly dose as received prior to enrollment
Drug: Folic Acid
According to local standard
Drug: Placebo (for sarilumab)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous
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

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR153191
  • REGN88
Drug: Methotrexate
Same weekly dose as received prior to enrollment
Drug: Folic Acid
According to local standard
Drug: Placebo (for sarilumab)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous
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

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR153191
  • REGN88
Drug: Methotrexate
Same weekly dose as received prior to enrollment
Drug: Folic Acid
According to local standard
Drug: Placebo (for sarilumab)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous
Placebo Comparator: Part A: Placebo qw
Placebo (for sarilumab) qw on top of MTX for 12 weeks.
Drug: Methotrexate
Same weekly dose as received prior to enrollment
Drug: Folic Acid
According to local standard
Drug: Placebo (for sarilumab)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous
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

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR153191
  • REGN88
Drug: Methotrexate
Same weekly dose as received prior to enrollment
Drug: Folic Acid
According to local standard
Drug: Placebo (for sarilumab)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous
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

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR153191
  • REGN88
Drug: Methotrexate
Same weekly dose as received prior to enrollment
Drug: Folic Acid
According to local standard
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

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR153191
  • REGN88
Drug: Methotrexate
Same weekly dose as received prior to enrollment
Drug: Folic Acid
According to local standard
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: Methotrexate
Same weekly dose as received prior to enrollment
Drug: Folic Acid
According to local standard
Drug: Placebo (for sarilumab)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Time Frame: Baseline to 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).
Baseline to Week 12
Part B: Percentage of Participants Achieving ACR20 Response at Week 24
Time Frame: Baseline to 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.
Baseline to Week 24
Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16
Time Frame: Baseline, 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.
Baseline, Week 16
Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52
Time Frame: Baseline, 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.
Baseline, Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52
Time Frame: Baseline up to 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.
Baseline up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Principal Investigator: Mark C Genovese, MD, Professor of Medicine, Division of Immunology and Rheumatology - Stanford University - USA
  • Study Chair: TWJ Huizinga, Prof Dr, Dpt of Rheumatology - Leiden University Medical Center - The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

February 2, 2010

First Submitted That Met QC Criteria

February 2, 2010

First Posted (Estimate)

February 3, 2010

Study Record Updates

Last Update Posted (Actual)

June 28, 2017

Last Update Submitted That Met QC Criteria

June 27, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC11072
  • 2009-016266-90 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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