An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate
NCT ID: NCT01764997
Last Updated: 2017-07-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
776 participants
INTERVENTIONAL
2013-04-30
2015-01-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Adalimumab Open Label run-in
Adalimumab 40 mg every 2 weeks (Q2W) for 16 weeks added to stable dose of MTX.
Methotrexate
Dispensed according to local practice.
Adalimumab
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
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.
Etanercept
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Methotrexate
Dispensed according to local practice.
Placebo (for sarilumab)
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.
Sarilumab
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Methotrexate
Dispensed according to local practice.
Placebo (for etanercept)
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.
Sarilumab
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Methotrexate
Dispensed according to local practice.
Placebo (for etanercept)
Sarilumab 150 mg + MTX Open Label Sub-study
Sarilumab 150 mg Q2W for 52 weeks added to stable dose of MTX.
Sarilumab
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Methotrexate
Dispensed according to local practice.
Interventions
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Sarilumab
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Etanercept
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Methotrexate
Dispensed according to local practice.
Placebo (for sarilumab)
Placebo (for etanercept)
Adalimumab
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 840004
Birmingham, Alabama, United States
Investigational Site Number 840212
Glendale, California, United States
Investigational Site Number 840211
Thousand Oaks, California, United States
Investigational Site Number 840049
Upland, California, United States
Investigational Site Number 840205
Victorville, California, United States
Investigational Site Number 840201
Denver, Colorado, United States
Investigational Site Number 840209
Danbury, Connecticut, United States
Investigational Site Number 840203
Washington D.C., District of Columbia, United States
Investigational Site Number 840210
Clearwater, Florida, United States
Investigational Site Number 840128
Ormond Beach, Florida, United States
Investigational Site Number 840063
Palm Harbor, Florida, United States
Investigational Site Number 840060
Sarasota, Florida, United States
Investigational Site Number 840207
Tampa, Florida, United States
Investigational Site Number 840018
Idaho Falls, Idaho, United States
Investigational Site Number 840213
Indianapolis, Indiana, United States
Investigational Site Number 840109
Lake Charles, Louisiana, United States
Investigational Site Number 840073
Cumberland, Maryland, United States
Investigational Site Number 840202
Hagerstown, Maryland, United States
Investigational Site Number 840204
Battle Creek, Michigan, United States
Investigational Site Number 840150
Lansing, Michigan, United States
Investigational Site Number 840200
Jackson, Mississippi, United States
Investigational Site Number 840037
Tupelo, Mississippi, United States
Investigational Site Number 840112
Lincoln, Nebraska, United States
Investigational Site Number 840056
New York, New York, United States
Investigational Site Number 840117
Pittsburgh, Pennsylvania, United States
Investigational Site Number 840016
North Charleston, South Carolina, United States
Investigational Site Number 840025
Jackson, Tennessee, United States
Investigational Site Number 840074
Mesquite, Texas, United States
Investigational Site Number 840061
Tacoma, Washington, United States
Investigational Site Number 840124
Clarksburg, West Virginia, United States
Investigational Site Number 032052
Buenos Aires, , Argentina
Investigational Site Number 032050
Buenos Aires, , Argentina
Investigational Site Number 032053
La Plata, , Argentina
Investigational Site Number 032013
Rosario, , Argentina
Investigational Site Number 032005
San Miguel de Tucumán, , Argentina
Investigational Site Number 032051
San Miguel de Tucumán, , Argentina
Investigational Site Number 032009
Zárate, , Argentina
Investigational Site Number 036020
Camperdown, , Australia
Investigational Site Number 036004
Heidelberg West, , Australia
Investigational Site Number 036014
Victoria Park, , Australia
Investigational Site Number 036007
Woodville, , Australia
Investigational Site Number 076001
Curitiba, , Brazil
Investigational Site Number 076016
Curitiba, , Brazil
Investigational Site Number 076006
Goiânia, , Brazil
Investigational Site Number 076010
Juiz de Fora, , Brazil
Investigational Site Number 076005
Rio de Janeiro, , Brazil
Investigational Site Number 076013
Vitória, , Brazil
Investigational Site Number 152005
Osorno, , Chile
Investigational Site Number 152018
Santiago, , Chile
Investigational Site Number 152001
Santiago, , Chile
Investigational Site Number 152002
Santiago, , Chile
Investigational Site Number 152011
Santiago, , Chile
Investigational Site Number 152015
Temuco, , Chile
Investigational Site Number 170016
Bogotá, , Colombia
Investigational Site Number 170040
Bogotá, , Colombia
Investigational Site Number 170001
Bogotá, , Colombia
Investigational Site Number 170007
Bucaramanga, , Colombia
Investigational Site Number 170009
Bucaramanga, , Colombia
Investigational Site Number 170041
Medellín, , Colombia
Investigational Site Number 203004
Ostrava, , Czechia
Investigational Site Number 203032
Prague, , Czechia
Investigational Site Number 203001
Prague, , Czechia
Investigational Site Number 203031
Prague, , Czechia
Investigational Site Number 203033
Prague, , Czechia
Investigational Site Number 203030
Prague, , Czechia
Investigational Site Number 203002
Uherské Hradiště, , Czechia
Investigational Site Number 203006
Zlín, , Czechia
Investigational Site Number 218003
Cuenca, , Ecuador
Investigational Site Number 218001
Guayaquil, , Ecuador
Investigational Site Number 218002
Quito, , Ecuador
Investigational Site Number 246001
Helsinki, , Finland
Investigational Site Number 246002
Hyvinkää, , Finland
Investigational Site Number 246030
Oulu, , Finland
Investigational Site Number 246003
Pori, , Finland
Investigational Site Number 246032
Tampere, , Finland
Investigational Site Number 250003
Amiens, , France
Investigational Site Number 250007
Bobigny, , France
Investigational Site Number 250001
La Roche-sur-Yon, , France
Investigational Site Number 250002
Montpellier, , France
Investigational Site Number 250005
Paris, , France
Investigational Site Number 250004
Paris, , France
Investigational Site Number 250006
Strasbourg, , France
Investigational Site Number 250008
Toulouse, , France
Investigational Site Number 276007
Berlin, , Germany
Investigational Site Number 276057
Berlin, , Germany
Investigational Site Number 276058
Cologne, , Germany
Investigational Site Number 276056
Dresden, , Germany
Investigational Site Number 276055
Dresden, , Germany
Investigational Site Number 276051
Erlangen, , Germany
Investigational Site Number 276013
Hamburg, , Germany
Investigational Site Number 276001
Herne, , Germany
Investigational Site Number 276053
Ludwigsfelde, , Germany
Investigational Site Number 276050
Rostock, , Germany
Investigational Site Number 300010
Athens, , Greece
Investigational Site Number 300002
Heraklion, , Greece
Investigational Site Number 300014
N. Efkarpia, , Greece
Investigational Site Number 300012
Pátrai, , Greece
Investigational Site Number 348001
Budapest, , Hungary
Investigational Site Number 348010
Debrecen, , Hungary
Investigational Site Number 348021
Esztergom, , Hungary
Investigational Site Number 348013
Gy?r, , Hungary
Investigational Site Number 348008
Gyula, , Hungary
Investigational Site Number 376032
Ashkelon, , Israel
Investigational Site Number 376001
Haifa, , Israel
Investigational Site Number 376010
Haifa, , Israel
Investigational Site Number 376031
Haifa, , Israel
Investigational Site Number 376035
Jerusalem, , Israel
Investigational Site Number 376030
Ramat Gan, , Israel
Investigational Site Number 376011
Tel Aviv, , Israel
Investigational Site Number 376034
Tel Litwinsky, , Israel
Investigational Site Number 380002
Florence, , Italy
Investigational Site Number 380004
Genova, , Italy
Investigational Site Number 380005
Genova, , Italy
Investigational Site Number 380041
L’Aquila, , Italy
Investigational Site Number 380042
Valeggio sul Mincio, , Italy
Investigational Site Number 428002
Liepāja, , Latvia
Investigational Site Number 428001
Riga, , Latvia
Investigational Site Number 428003
Ventspils, , Latvia
Investigational Site Number 440005
Kaunas, , Lithuania
Investigational Site Number 440006
Klaipėda, , Lithuania
Investigational Site Number 440010
Panevezys, , Lithuania
Investigational Site Number 440011
Vilnius, , Lithuania
Investigational Site Number 458012
Batu Caves, , Malaysia
Investigational Site Number 458014
George Town, , Malaysia
Investigational Site Number 458001
Ipoh, , Malaysia
Investigational Site Number 458013
Kota Bharu, , Malaysia
Investigational Site Number 458002
Kuching, , Malaysia
Investigational Site Number 458010
Malacca, , Malaysia
Investigational Site Number 458011
Seremban, , Malaysia
Investigational Site Number 484023
Chihuahua City, , Mexico
Investigational Site Number 484027
Ciudad Obregón, , Mexico
Investigational Site Number 484029
Deleg. Benito Juárez, , Mexico
Investigational Site Number 484013
Guadalajara, , Mexico
Investigational Site Number 484018
Guadalajara, , Mexico
Investigational Site Number 484010
Mexicali, , Mexico
Investigational Site Number 484026
Mexicali, , Mexico
Investigational Site Number 484052
Mexico City, , Mexico
Investigational Site Number 484004
Mérida, , Mexico
Investigational Site Number 484017
México, , Mexico
Investigational Site Number 484025
San Luis, , Mexico
Investigational Site Number 484051
Tijuana, , Mexico
Investigational Site Number 554007
Auckland, , New Zealand
Investigational Site Number 554010
Dunedin, , New Zealand
Investigational Site Number 554005
Hamilton, , New Zealand
Investigational Site Number 554011
Nelson, , New Zealand
Investigational Site Number 604001
Lima, , Peru
Investigational Site Number 604010
Lima, , Peru
Investigational Site Number 604009
Lima, , Peru
Investigational Site Number 604012
Lima, , Peru
Investigational Site Number 604007
Lima, , Peru
Investigational Site Number 604005
Lima, , Peru
Investigational Site Number 604020
Lima, , Peru
Investigational Site Number 616019
Bydgoszcz, , Poland
Investigational Site Number 616054
Bytom, , Poland
Investigational Site Number 616052
Działdowo, , Poland
Investigational Site Number 616015
Elblag, , Poland
Investigational Site Number 616057
Krakow, , Poland
Investigational Site Number 616059
Krakow, , Poland
Investigational Site Number 616061
Krakow, , Poland
Investigational Site Number 616005
Lublin, , Poland
Investigational Site Number 616063
Myślenice, , Poland
Investigational Site Number 616018
Poznan, , Poland
Investigational Site Number 616013
Sosnowiec, , Poland
Investigational Site Number 616056
Starachowice, , Poland
Investigational Site Number 616016
Szczecin, , Poland
Investigational Site Number 616058
Ustroń, , Poland
Investigational Site Number 616051
Warsaw, , Poland
Investigational Site Number 616053
Żyrardów, , Poland
Investigational Site Number 642041
Bacau, , Romania
Investigational Site Number 642001
Bucharest, , Romania
Investigational Site Number 642040
Bucharest, , Romania
Investigational Site Number 642002
Bucharest, , Romania
Investigational Site Number 642012
Bucharest, , Romania
Investigational Site Number 642004
Bucharest, , Romania
Investigational Site Number 642023
Bucharest, , Romania
Investigational Site Number 642042
Bucharest, , Romania
Investigational Site Number 642005
Galati, , Romania
Investigational Site Number 642013
Iași, , Romania
Investigational Site Number 642014
Iași, , Romania
Investigational Site Number 642022
Târgovişte, , Romania
Investigational Site Number 643006
Kemerovo, , Russia
Investigational Site Number 643056
Krasnoyarsk, , Russia
Investigational Site Number 643052
Moscow, , Russia
Investigational Site Number 643021
Moscow, , Russia
Investigational Site Number 643031
Moscow, , Russia
Investigational Site Number 643030
Moscow, , Russia
Investigational Site Number 643022
Novosibirsk, , Russia
Investigational Site Number 643058
Saint Peterburg, , Russia
Investigational Site Number 643008
Saint Petersburg, , Russia
Investigational Site Number 643010
Samara, , Russia
Investigational Site Number 643011
Saratov, , Russia
Investigational Site Number 643059
Smolensk, , Russia
Investigational Site Number 643013
Ufa, , Russia
Investigational Site Number 643050
Voronezh, , Russia
Investigational Site Number 643057
Yaroslavl, , Russia
Investigational Site Number 643051
Yaroslavl, , Russia
Investigational Site Number 710011
Cape Town, , South Africa
Investigational Site Number 710007
Cape Town, , South Africa
Investigational Site Number 710008
Pretoria, , South Africa
Investigational Site Number 710006
Pretoria, , South Africa
Investigational Site Number 710010
Stellenbsoch, , South Africa
Investigational Site Number 410020
Busan, , South Korea
Investigational Site Number 410006
Busan, , South Korea
Investigational Site Number 410013
Daegu, , South Korea
Investigational Site Number 410005
Daejeon, , South Korea
Investigational Site Number 410011
Jeonju, , South Korea
Investigational Site Number 410016
Seoul, , South Korea
Investigational Site Number 410015
Seoul, , South Korea
Investigational Site Number 410022
Seoul, , South Korea
Investigational Site Number 410023
Seoul, , South Korea
Investigational Site Number 410021
Seoul, , South Korea
Investigational Site Number 410008
Suwon, , South Korea
Investigational Site Number 724009
A Coruña, , Spain
Investigational Site Number 724043
Córdoba, , Spain
Investigational Site Number 724042
Madrid, , Spain
Investigational Site Number 724041
Madrid, , Spain
Investigational Site Number 724040
Madrid, , Spain
Investigational Site Number 724001
Málaga, , Spain
Investigational Site Number 724011
Sabadell, , Spain
Investigational Site Number 724012
Santiago de Compostela, , Spain
Investigational Site Number 158010
Changhua, , Taiwan
Investigational Site Number 158004
Chiayi City, , Taiwan
Investigational Site Number 158012
Kaohsiung City, , Taiwan
Investigational Site Number 158011
Kaohsiung City, , Taiwan
Investigational Site Number 158006
Taipei, , Taiwan
Investigational Site Number 764002
Bangkok, , Thailand
Investigational Site Number 764010
Bangkok, , Thailand
Investigational Site Number 764003
Bangkok Noi, , Thailand
Investigational Site Number 764011
Khon Kaen, , Thailand
Investigational Site Number 804003
Dnipropetrovsk, , Ukraine
Investigational Site Number 804002
Donetsk, , Ukraine
Investigational Site Number 804024
Donetsk, , Ukraine
Investigational Site Number 804029
Ivano-Frankivsk, , Ukraine
Investigational Site Number 804010
Kharkiv, , Ukraine
Investigational Site Number 804001
Kharkiv, , Ukraine
Investigational Site Number 804025
Kiev, , Ukraine
Investigational Site Number 804023
Kyiv, , Ukraine
Investigational Site Number 804014
Kyiv, , Ukraine
Investigational Site Number 804027
Kyiv, , Ukraine
Investigational Site Number 804011
Kyiv, , Ukraine
Investigational Site Number 804030
Lutsk, , Ukraine
Investigational Site Number 804005
Lviv, , Ukraine
Investigational Site Number 804033
Lviv, , Ukraine
Investigational Site Number 804020
Lviv, , Ukraine
Investigational Site Number 804032
Odesa, , Ukraine
Investigational Site Number 804022
Odesa, , Ukraine
Investigational Site Number 804012
Odesa, , Ukraine
Investigational Site Number 804021
Simferopol, , Ukraine
Investigational Site Number 804028
Zaporizhzhya, , Ukraine
Investigational Site Number 804031
Zhytomyr, , Ukraine
Investigational Site Number 826023
Barnsley, , United Kingdom
Investigational Site Number 826022
Birmingham, , United Kingdom
Investigational Site Number 826021
Dudley, , United Kingdom
Investigational Site Number 826026
Durham, , United Kingdom
Investigational Site Number 826027
Durham, , United Kingdom
Investigational Site Number 826020
Harlow, , United Kingdom
Investigational Site Number 826025
Wigan, , United Kingdom
Countries
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Other Identifiers
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2012-001984-66
Identifier Type: -
Identifier Source: secondary_id
U1111-1131-6653
Identifier Type: OTHER
Identifier Source: secondary_id
EFC11574
Identifier Type: -
Identifier Source: org_study_id
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