An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: Placebo (for etanercept)Drug: Placebo (for sarilumab)
- Registration Number
- NCT01764997
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 776
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sarilumab 150 mg + MTX (Randomized) Sarilumab 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. Adalimumab Open Label run-in Adalimumab Adalimumab 40 mg every 2 weeks (Q2W) for 16 weeks added to stable dose of MTX. Sarilumab 150 mg + MTX (Randomized) Methotrexate 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 150 mg + MTX (Randomized) Placebo (for etanercept) 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. Etanercept + MTX (Randomized) Etanercept 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 + MTX (Randomized) Methotrexate 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 + MTX (Randomized) Placebo (for sarilumab) 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. Sarilumab 200 mg + MTX (Randomized) Placebo (for etanercept) 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 150 mg + MTX Open Label Sub-study Sarilumab Sarilumab 150 mg Q2W for 52 weeks added to stable dose of MTX. Adalimumab Open Label run-in Methotrexate Adalimumab 40 mg every 2 weeks (Q2W) for 16 weeks added to stable dose of MTX. Sarilumab 200 mg + MTX (Randomized) Sarilumab 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 200 mg + MTX (Randomized) Methotrexate 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 150 mg + MTX Open Label Sub-study Methotrexate Sarilumab 150 mg Q2W for 52 weeks added to stable dose of MTX.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (257)
Investigational Site Number 840203
🇺🇸Washington, D.C., District of Columbia, United States
Investigational Site Number 032009
🇦🇷Zarate, Argentina
Investigational Site Number 152018
🇨🇱Santiago, Chile
Investigational Site Number 170041
🇨🇴Medellin, Colombia
Investigational Site Number 840150
🇺🇸Lansing, Michigan, United States
Investigational Site Number 840200
🇺🇸Jackson, Mississippi, United States
Investigational Site Number 032053
🇦🇷La Plata, Argentina
Investigational Site Number 076006
🇧🇷Goiania, Brazil
Investigational Site Number 840210
🇺🇸Clearwater, Florida, United States
Investigational Site Number 152015
🇨🇱Temuco, Chile
Investigational Site Number 170040
🇨🇴Bogotá, Colombia
Investigational Site Number 218001
🇪🇨Guayaquil, Ecuador
Investigational Site Number 250006
🇫🇷Strasbourg, France
Investigational Site Number 840060
🇺🇸Sarasota, Florida, United States
Investigational Site Number 032050
🇦🇷Buenos Aires, Argentina
Investigational Site Number 032013
🇦🇷Rosario, Argentina
Investigational Site Number 032005
🇦🇷Tucuman, Argentina
Investigational Site Number 840073
🇺🇸Cumberland, Maryland, United States
Investigational Site Number 840025
🇺🇸Jackson, Tennessee, United States
Investigational Site Number 840202
🇺🇸Hagerstown, Maryland, United States
Investigational Site Number 840016
🇺🇸North Charleston, South Carolina, United States
Investigational Site Number 076010
🇧🇷Juiz De Fora, Brazil
Investigational Site Number 152001
🇨🇱Santiago, Chile
Investigational Site Number 170007
🇨🇴Bucaramanga, Colombia
Investigational Site Number 246001
🇫🇮Helsinki, Finland
Investigational Site Number 250003
🇫🇷Amiens Cedex 1, France
Investigational Site Number 840204
🇺🇸Battle Creek, Michigan, United States
Investigational Site Number 032051
🇦🇷San Miguel De Tucumán, Argentina
Investigational Site Number 076001
🇧🇷Curitiba, Brazil
Investigational Site Number 152005
🇨🇱Osorno, Chile
Investigational Site Number 152002
🇨🇱Santiago, Chile
Investigational Site Number 170001
🇨🇴Bogota, Colombia
Investigational Site Number 246030
🇫🇮Oulu, Finland
Investigational Site Number 076016
🇧🇷Curitiba, Brazil
Investigational Site Number 076005
🇧🇷Rio De Janeiro, Brazil
Investigational Site Number 076013
🇧🇷Vitoria, Brazil
Investigational Site Number 250005
🇫🇷Paris, France
Investigational Site Number 152011
🇨🇱Santiago, Chile
Investigational Site Number 170016
🇨🇴Bogota, Colombia
Investigational Site Number 276056
🇩🇪Dresden, Germany
Investigational Site Number 276053
🇩🇪Ludwigsfelde, Germany
Investigational Site Number 300012
🇬🇷Patras, Greece
Investigational Site Number 376010
🇮🇱Haifa, Israel
Investigational Site Number 380002
🇮🇹Firenze, Italy
Investigational Site Number 410016
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 250008
🇫🇷Toulouse, France
Investigational Site Number 218002
🇪🇨Quito, Ecuador
Investigational Site Number 250007
🇫🇷Bobigny, France
Investigational Site Number 250004
🇫🇷Paris Cedex 4, France
Investigational Site Number 276055
🇩🇪Dresden, Germany
Investigational Site Number 276001
🇩🇪Herne, Germany
Investigational Site Number 276050
🇩🇪Rostock, Germany
Investigational Site Number 276057
🇩🇪Berlin, Germany
Investigational Site Number 348001
🇭🇺Budapest, Hungary
Investigational Site Number 246032
🇫🇮Tampere, Finland
Investigational Site Number 300010
🇬🇷Athens, Greece
Investigational Site Number 376034
🇮🇱Tel Hashomer, Israel
Investigational Site Number 380005
🇮🇹Genova, Italy
Investigational Site Number 410020
🇰🇷Busan, Korea, Republic of
Investigational Site Number 410005
🇰🇷Daejeon, Korea, Republic of
Investigational Site Number 428001
🇱🇻Riga, Latvia
Investigational Site Number 458001
🇲🇾Ipoh, Malaysia
Investigational Site Number 276007
🇩🇪Berlin, Germany
Investigational Site Number 410022
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410023
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 250001
🇫🇷La Roche Sur Yon Cedex 9, France
Investigational Site Number 250002
🇫🇷Montpellier, France
Investigational Site Number 276051
🇩🇪Erlangen, Germany
Investigational Site Number 348021
🇭🇺Esztergom, Hungary
Investigational Site Number 376011
🇮🇱Tel Aviv, Israel
Investigational Site Number 616018
🇵🇱Poznan, Poland
Investigational Site Number 616016
🇵🇱Szczecin, Poland
Investigational Site Number 616058
🇵🇱Ustron, Poland
Investigational Site Number 410015
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410021
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 276013
🇩🇪Hamburg, Germany
Investigational Site Number 276058
🇩🇪Koeln, Germany
Investigational Site Number 380042
🇮🇹Valeggio Sul Mincio, Italy
Investigational Site Number 410011
🇰🇷Jeonju, Korea, Republic of
Investigational Site Number 428003
🇱🇻Ventspils, Latvia
Investigational Site Number 554011
🇳🇿Nelson, New Zealand
Investigational Site Number 616054
🇵🇱Bytom, Poland
Investigational Site Number 616013
🇵🇱Sosnowiec, Poland
Investigational Site Number 300014
🇬🇷N. Efkarpia, Greece
Investigational Site Number 376001
🇮🇱Haifa, Israel
Investigational Site Number 376035
🇮🇱Jerusalem, Israel
Investigational Site Number 376030
🇮🇱Ramat Gan, Israel
Investigational Site Number 410008
🇰🇷Suwon, Korea, Republic of
Investigational Site Number 428002
🇱🇻Liepaja, Latvia
Investigational Site Number 440005
🇱🇹Kaunas, Lithuania
Investigational Site Number 840124
🇺🇸Clarksburg, West Virginia, United States
Investigational Site Number 440011
🇱🇹Vilnius, Lithuania
Investigational Site Number 616015
🇵🇱Elblag, Poland
Investigational Site Number 616061
🇵🇱Krakow, Poland
Investigational Site Number 616056
🇵🇱Starachowice, Poland
Investigational Site Number 642023
🇷🇴Bucharest, Romania
Investigational Site Number 642040
🇷🇴Bucuresti, Romania
Investigational Site Number 616052
🇵🇱Dzialdowo, Poland
Investigational Site Number 616059
🇵🇱Krakow, Poland
Investigational Site Number 616005
🇵🇱Lublin, Poland
Investigational Site Number 616051
🇵🇱Warszawa, Poland
Investigational Site Number 642005
🇷🇴Galati, Romania
Investigational Site Number 642013
🇷🇴Iasi, Romania
Investigational Site Number 642004
🇷🇴Bucharest, Romania
Investigational Site Number 642002
🇷🇴Bucuresti, Romania
Investigational Site Number 642001
🇷🇴Bucuresti, Romania
Investigational Site Number 643022
🇷🇺Novosibirsk, Russian Federation
Investigational Site Number 643010
🇷🇺Samara, Russian Federation
Investigational Site Number 643011
🇷🇺Saratov, Russian Federation
Investigational Site Number 642042
🇷🇴Bucuresti, Romania
Investigational Site Number 642022
🇷🇴Targoviste, Romania
Investigational Site Number 643051
🇷🇺Yaroslavl, Russian Federation
Investigational Site Number 643031
🇷🇺Moscow, Russian Federation
Investigational Site Number 642014
🇷🇴Iasi, Romania
Investigational Site Number 643006
🇷🇺Kemerovo, Russian Federation
Investigational Site Number 158010
🇨🇳Changhua, Taiwan
Investigational Site Number 643052
🇷🇺Moscow, Russian Federation
Investigational Site Number 643021
🇷🇺Moscow, Russian Federation
Investigational Site Number 643008
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 158012
🇨🇳Kaohsiung, Taiwan
Investigational Site Number 158011
🇨🇳Kaohsiung, Taiwan
Investigational Site Number 804022
🇺🇦Odesa, Ukraine
Investigational Site Number 643030
🇷🇺Moscow, Russian Federation
Investigational Site Number 643059
🇷🇺Smolensk, Russian Federation
Investigational Site Number 643058
🇷🇺St. Peterburg, Russian Federation
Investigational Site Number 643013
🇷🇺Ufa, Russian Federation
Investigational Site Number 643050
🇷🇺Voronezh, Russian Federation
Investigational Site Number 804001
🇺🇦Kharkov, Ukraine
Investigational Site Number 804023
🇺🇦Kyiv, Ukraine
Investigational Site Number 804030
🇺🇦Lutsk, Ukraine
Investigational Site Number 643057
🇷🇺Yaroslavl, Russian Federation
Investigational Site Number 764011
🇹🇭Khon Kaen, Thailand
Investigational Site Number 158006
🇨🇳Taipei, Taiwan
Investigational Site Number 158004
🇨🇳Chia-Yi, Taiwan
Investigational Site Number 764003
🇹🇭Bangkok-Noi, Thailand
Investigational Site Number 764010
🇹🇭Bangkok, Thailand
Investigational Site Number 804010
🇺🇦Kharkiv, Ukraine
Investigational Site Number 804025
🇺🇦Kiev, Ukraine
Investigational Site Number 804020
🇺🇦Lviv, Ukraine
Investigational Site Number 804002
🇺🇦Donetsk, Ukraine
Investigational Site Number 804024
🇺🇦Donetsk, Ukraine
Investigational Site Number 804014
🇺🇦Kyiv, Ukraine
Investigational Site Number 804029
🇺🇦Ivano-Frankivsk, Ukraine
Investigational Site Number 804027
🇺🇦Kyiv, Ukraine
Investigational Site Number 804012
🇺🇦Odessa, Ukraine
Investigational Site Number 804028
🇺🇦Zaporozhye, Ukraine
Investigational Site Number 804031
🇺🇦Zhytomyr, Ukraine
Investigational Site Number 804011
🇺🇦Kyiv, Ukraine
Investigational Site Number 804005
🇺🇦Lviv, Ukraine
Investigational Site Number 804033
🇺🇦Lviv, Ukraine
Investigational Site Number 840128
🇺🇸Ormond Beach, Florida, United States
Investigational Site Number 840056
🇺🇸New York, New York, United States
Investigational Site Number 840018
🇺🇸Idaho Falls, Idaho, United States
Investigational Site Number 840074
🇺🇸Mesquite, Texas, United States
Investigational Site Number 840037
🇺🇸Tupelo, Mississippi, United States
Investigational Site Number 840112
🇺🇸Lincoln, Nebraska, United States
Investigational Site Number 203030
🇨🇿Praha 4, Czechia
Investigational Site Number 203006
🇨🇿Zlin, Czechia
Investigational Site Number 840061
🇺🇸Tacoma, Washington, United States
Investigational Site Number 036020
🇦🇺Camperdown, Australia
Investigational Site Number 036007
🇦🇺Woodville, Australia
Investigational Site Number 203004
🇨🇿Ostrava, Czechia
Investigational Site Number 840209
🇺🇸Danbury, Connecticut, United States
Investigational Site Number 840205
🇺🇸Victorville, California, United States
Investigational Site Number 840109
🇺🇸Lake Charles, Louisiana, United States
Investigational Site Number 032052
🇦🇷Buenos Aires, Argentina
Investigational Site Number 840117
🇺🇸Pittsburgh, Pennsylvania, United States
Investigational Site Number 203031
🇨🇿Praha 4, Czechia
Investigational Site Number 036004
🇦🇺Heidelberg West, Australia
Investigational Site Number 036014
🇦🇺Victoria Park, Australia
Investigational Site Number 348013
🇭🇺Gy?r, Hungary
Investigational Site Number 170009
🇨🇴Bucaramanga, Colombia
Investigational Site Number 203001
🇨🇿Praha 2, Czechia
Investigational Site Number 203002
🇨🇿Uherske Hradiste, Czechia
Investigational Site Number 218003
🇪🇨Cuenca, Ecuador
Investigational Site Number 246002
🇫🇮Hyvinkää, Finland
Investigational Site Number 246003
🇫🇮Pori, Finland
Investigational Site Number 203033
🇨🇿Praha 4, Czechia
Investigational Site Number 203032
🇨🇿Praha, Czechia
Investigational Site Number 376032
🇮🇱Ashkelon, Israel
Investigational Site Number 380004
🇮🇹Genova, Italy
Investigational Site Number 380041
🇮🇹L'Aquila, Italy
Investigational Site Number 724042
🇪🇸Madrid, Spain
Investigational Site Number 710008
🇿🇦Pretoria, South Africa
Investigational Site Number 724001
🇪🇸Málaga, Spain
Investigational Site Number 724011
🇪🇸Sabadell, Spain
Investigational Site Number 616053
🇵🇱Zyrardow, Poland
Investigational Site Number 826021
🇬🇧Dudley, United Kingdom
Investigational Site Number 826020
🇬🇧Harlow, United Kingdom
Investigational Site Number 724040
🇪🇸Madrid, Spain
Investigational Site Number 642012
🇷🇴Bucharest, Romania
Investigational Site Number 826025
🇬🇧Wigan, United Kingdom
Investigational Site Number 724009
🇪🇸La Coruña, Spain
Investigational Site Number 710010
🇿🇦Stellenbsoch, South Africa
Investigational Site Number 724041
🇪🇸Madrid, Spain
Investigational Site Number 724043
🇪🇸Córdoba, Spain
Investigational Site Number 643056
🇷🇺Krasnoyarsk, Russian Federation
Investigational Site Number 826022
🇬🇧Birmingham, United Kingdom
Investigational Site Number 724012
🇪🇸Santiago De Compostela, Spain
Investigational Site Number 710011
🇿🇦Cape Town, South Africa
Investigational Site Number 710006
🇿🇦Pretoria, South Africa
Investigational Site Number 826026
🇬🇧Durham, United Kingdom
Investigational Site Number 840004
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 840213
🇺🇸Indianapolis, Indiana, United States
Investigational Site Number 840201
🇺🇸Denver, Colorado, United States
Investigational Site Number 840207
🇺🇸Tampa, Florida, 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 300002
🇬🇷Heraklion, Greece
Investigational Site Number 348010
🇭🇺Debrecen, Hungary
Investigational Site Number 348008
🇭🇺Gyula, Hungary
Investigational Site Number 376031
🇮🇱Haifa, Israel
Investigational Site Number 410006
🇰🇷Busan, Korea, Republic of
Investigational Site Number 410013
🇰🇷Daegu, Korea, Republic of
Investigational Site Number 440006
🇱🇹Klaipeda, Lithuania
Investigational Site Number 440010
🇱🇹Panevezys, Lithuania
Investigational Site Number 458012
🇲🇾Batu Caves, Malaysia
Investigational Site Number 458014
🇲🇾Georgetown, Malaysia
Investigational Site Number 458013
🇲🇾Kota Bharu, Malaysia
Investigational Site Number 458002
🇲🇾Kuching, Malaysia
Investigational Site Number 458010
🇲🇾Melaka, Malaysia
Investigational Site Number 458011
🇲🇾Seremban, Malaysia
Investigational Site Number 484027
🇲🇽Cd. Obregon, Mexico
Investigational Site Number 484023
🇲🇽Chihuahua, Mexico
Investigational Site Number 484029
🇲🇽Deleg. Benito Juárez, Mexico
Investigational Site Number 484013
🇲🇽Guadalajara, Mexico
Investigational Site Number 484018
🇲🇽Guadalajara, Mexico
Investigational Site Number 484004
🇲🇽Merida, Mexico
Investigational Site Number 484052
🇲🇽Mexico City, Mexico
Investigational Site Number 484010
🇲🇽Mexicali, Mexico
Investigational Site Number 484026
🇲🇽Mexicali, Mexico
Investigational Site Number 484017
🇲🇽México, Mexico
Investigational Site Number 484051
🇲🇽Tijuana, Mexico
Investigational Site Number 484025
🇲🇽San Luis, Mexico
Investigational Site Number 554010
🇳🇿Dunedin, New Zealand
Investigational Site Number 554007
🇳🇿Auckland, New Zealand
Investigational Site Number 554005
🇳🇿Hamilton, New Zealand
Investigational Site Number 604001
🇵🇪Lima, Peru
Investigational Site Number 604009
🇵🇪Lima, Peru
Investigational Site Number 604010
🇵🇪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 616057
🇵🇱Krakow, Poland
Investigational Site Number 616063
🇵🇱Myslenice, Poland
Investigational Site Number 642041
🇷🇴Bacau, Romania
Investigational Site Number 710007
🇿🇦Cape Town, South Africa
Investigational Site Number 764002
🇹🇭Bangkok, Thailand
Investigational Site Number 804003
🇺🇦Dnipropetrovsk, Ukraine
Investigational Site Number 804021
🇺🇦Simferopol, Ukraine
Investigational Site Number 826023
🇬🇧Barnsley, United Kingdom
Investigational Site Number 804032
🇺🇦Odesa, Ukraine
Investigational Site Number 826027
🇬🇧Durham, United Kingdom
Investigational Site Number 840063
🇺🇸Palm Harbor, Florida, United States