Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
March 21, 2022 updated by: Sanofi
A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)
Main Study:
Primary Objective:
Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA).
Secondary Objective:
Assess the long term efficacy of sarilumab in participants with RA.
Sub-Study:
This phase 3, open label sub-study was aimed to assess the usability of PFS-S when used by participants with moderate or severe RA, or their professional or non-professional healthcare providers in an unsupervised real-world situation. To mimic the real-world practice, the sub-study was incorporated into the LTS11210 study without additional visits compared to the scheduled visits in the main study. The duration of this sub-study was 12 weeks.
Study Overview
Detailed Description
The maximum duration of the study was up to 523 weeks:
- Up to 1-week of screening, if any.
- At least 264 weeks of open label treatment phase and up to 516 weeks as maximum.
- 6-week post-treatment follow-up as required per protocol.
Study Type
Interventional
Enrollment (Actual)
2023
Phase
- 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
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Caba, Argentina, C1015ABO
- Investigational Site Number 032006
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Caba, Argentina, C1055AAF
- Investigational Site Number 032007
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Caba, Argentina, C1428DZF
- Investigational Site Number 032008
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Capital Federal, Argentina, 1180
- Investigational Site Number 032019
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Capital Federal, Argentina, 1425
- Investigational Site Number 032016
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Cordoba, Argentina, X5004BAL
- Investigational Site Number 032002
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Cordoba, Argentina, X5016KEH
- Investigational Site Number 032020
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Córdoba, Argentina
- Investigational Site Number 032003
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La Plata, Argentina, B1902
- Investigational Site Number 032017
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Mar Del Plata, Argentina, B7600FZN
- Investigational Site Number 032012
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Quilmes, Argentina, B1878DVB
- Investigational Site Number 032011
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Ramos Mejia, Argentina, B1704ETD
- Investigational Site Number 032010
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Rosario, Argentina, 2000
- Investigational Site Number 032001
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Rosario, Argentina, S2000PBJ
- Investigational Site Number 032013
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San Fernando, Argentina, 1646
- Investigational Site Number 032015
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San Miguel De Tucuman, Argentina, 4000
- Investigational Site Number 032005
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San Miguel De Tucuman, Argentina, T4000AXL
- Investigational Site Number 032004
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Zarate, Argentina, B2800DGH
- Investigational Site Number 032009
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Camperdown, Australia, 2050
- Investigational Site Number 036003
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Fitzroy, Australia, 3065
- Investigational Site Number 036012
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Garran, Australia, 2605
- Investigational Site Number 036010
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Heidelberg West, Australia, 3081
- Investigational Site Number 036004
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Maroochydore, Australia, 4558
- Investigational Site Number 036001
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Victoria Park, Australia, 6100
- Investigational Site Number 036014
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Woodville, Australia, 5011
- Investigational Site Number 036007
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Graz, Austria, 8036
- Investigational Site Number 040001
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Minsk, Belarus, 220037
- Investigational Site Number 112002
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Minsk, Belarus, 220116
- Investigational Site Number 112001
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Leuven, Belgium, 3000
- Investigational Site Number 056010
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Curitiba, Brazil, 80060-240
- Investigational Site Number 076001
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Goiania, Brazil, 74110-120
- Investigational Site Number 076006
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Juiz De Fora, Brazil, 36010-570
- Investigational Site Number 076010
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Porto Alegre, Brazil, 90610-000
- Investigational Site Number 076004
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Rio De Janeiro, Brazil, 20551-030
- Investigational Site Number 076005
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Rio De Janeiro, Brazil, 22271-100
- Investigational Site Number 076015
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Salvador, Brazil, 40050-410
- Investigational Site Number 076011
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Sao Paulo, Brazil, 04039-901
- Investigational Site Number 076002
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Sao Paulo, Brazil, 04266-010
- Investigational Site Number 076003
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Vitoria, Brazil, 29055 450
- Investigational Site Number 076013
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Mississauga, Canada, L5M 2V8
- Investigational Site Number 124003
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St. Catharines, Canada, L2N 7E4
- Investigational Site Number 124002
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Toronto, Canada, M5T 2S8
- Investigational Site Number 124005
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Trois-Rivières, Canada, G8Z 1Y2
- Investigational Site Number 124009
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Victoria, Canada, V8V 3P9
- Investigational Site Number 124104
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Winnipeg, Canada, R3A 1M3
- Investigational Site Number 124012
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Osorno, Chile, 5311092
- Investigational Site Number 152005
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Santiago, Chile, 7500922
- Investigational Site Number 152012
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Santiago, Chile, 7501126
- Investigational Site Number 152002
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Santiago, Chile, 7510186
- Investigational Site Number 152011
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Santiago, Chile, 8207257
- Investigational Site Number 152009
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Santiago, Chile, 8360156
- Investigational Site Number 152001
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Santiago, Chile, 8360156
- Investigational Site Number 152013
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Santiago, Chile
- Investigational Site Number 152008
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Talca, Chile
- Investigational Site Number 152014
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Temuco IX Region, Chile, 4790928
- Investigational Site Number 152015
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Valdivia, Chile, 5090146
- Investigational Site Number 152004
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Vina Del Mar, Chile
- Investigational Site Number 152006
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Viña Del Mar, Chile, 2520997
- Investigational Site Number 152007
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Barranquilla, Colombia, 080020399
- Investigational Site Number 170005
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Barranquilla, Colombia, 99999
- Investigational Site Number 170004
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Bogota, Colombia, 110221042
- Investigational Site Number 170001
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Bogota, Colombia, 111211626
- Investigational Site Number 170008
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Bogotá, Colombia, 11011
- Investigational Site Number 170006
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Bogotá, Colombia, 111211191
- Investigational Site Number 170003
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Bucaramanga, Colombia, 680003288
- Investigational Site Number 170007
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Bucaramanga, Colombia, 680003
- Investigational Site Number 170009
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Liberec, Czechia, 46063
- Investigational Site Number 203009
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Ostrava, Czechia, 702 00
- Investigational Site Number 203004
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Pardubice, Czechia, 53002
- Investigational Site Number 203034
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Praha 2, Czechia, 12850
- Investigational Site Number 203001
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Praha 2, Czechia, 12850
- Investigational Site Number 203007
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Praha 2, Czechia, 12850
- Investigational Site Number 203011
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Praha 4, Czechia, 140 00
- Investigational Site Number 203010
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Uherske Hradiste, Czechia, 686 01
- Investigational Site Number 203002
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Zlin, Czechia, 760 01
- Investigational Site Number 203006
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Cuenca, Ecuador, 010204
- Investigational Site Number 218003
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Guayaquil, Ecuador, 090109
- Investigational Site Number 218001
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Quito, Ecuador, 170524
- Investigational Site Number 218002
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Tallinn, Estonia, 10128
- Investigational Site Number 233001
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Tallinn, Estonia, 10138
- Investigational Site Number 233010
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Tallinn, Estonia, 13419
- Investigational Site Number 233002
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Helsinki, Finland, 00290
- Investigational Site Number 246001
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Hyvinkää, Finland, 05800
- Investigational Site Number 246002
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Pori, Finland, 28100
- Investigational Site Number 246003
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Riihimäki, Finland, 11120
- Investigational Site Number 246010
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Bad Nauheim, Germany, 61231
- Investigational Site Number 276011
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Berlin, Germany, 10117
- Investigational Site Number 276010
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Berlin, Germany, 12161
- Investigational Site Number 276007
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Berlin, Germany, 12163
- Investigational Site Number 276008
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Berlin, Germany, 14059
- Investigational Site Number 276014
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Deggingen, Germany, 73326
- Investigational Site Number 276018
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Halle/Saale, Germany, 06108
- Investigational Site Number 276015
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Hamburg, Germany, 22081
- Investigational Site Number 276005
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Hamburg, Germany, 22147
- Investigational Site Number 276013
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Herne, Germany, 44649
- Investigational Site Number 276001
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Leipzig, Germany, 04103
- Investigational Site Number 276016
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München, Germany, 80336
- Investigational Site Number 276017
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Osnabrück, Germany, 49074
- Investigational Site Number 276021
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Tübingen, Germany, 72076
- Investigational Site Number 276020
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Zerbst, Germany, 39261
- Investigational Site Number 276019
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Heraklion, Greece, 71110
- Investigational Site Number 300002
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Thessaloniki, Greece, 54636
- Investigational Site Number 300003
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Thessaloniki, Greece, 57010
- Investigational Site Number 300005
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Guatemala, Guatemala, 9090
- Investigational Site Number 320001
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Guatemala City, Guatemala, 01009
- Investigational Site Number 320002
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Guatemala City, Guatemala, 01011
- Investigational Site Number 320003
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Budapest, Hungary, 1023
- Investigational Site Number 348006
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Budapest, Hungary, 1027
- Investigational Site Number 348014
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Budapest, Hungary, 1027
- Investigational Site Number 348025
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Budapest, Hungary, 1036
- Investigational Site Number 348022
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Debrecen, Hungary, 4031
- Investigational Site Number 348010
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Debrecen, Hungary, 4032
- Investigational Site Number 348003
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Esztergom, Hungary, 2500
- Investigational Site Number 348021
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Györ, Hungary, 9025
- Investigational Site Number 348013
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Szolnok, Hungary, 5000
- Investigational Site Number 348009
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Szombathely, Hungary, 9700
- Investigational Site Number 348015
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Székesfehérvár, Hungary, 8000
- Investigational Site Number 348004
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Sátoraljaújhely, Hungary, 3980
- Investigational Site Number 348005
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Haifa, Israel, 31048
- Investigational Site Number 376001
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Haifa, Israel, 31096
- Investigational Site Number 376010
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Tel Aviv, Israel, 64239
- Investigational Site Number 376011
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Tel Hashomer, Israel, 52621
- Investigational Site Number 376002
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Genova, Italy, 16132
- Investigational Site Number 380005
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Anyang-Si, Korea, Republic of, 431-070
- Investigational Site Number 410014
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Busan, Korea, Republic of, 602-739
- Investigational Site Number 410006
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Daegu, Korea, Republic of, 700-721
- Investigational Site Number 410004
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Daejeon, Korea, Republic of, 301-721
- Investigational Site Number 410017
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Daejeon, Korea, Republic of, 302-799
- Investigational Site Number 410005
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Gwangju, Korea, Republic of, 61469
- Investigational Site Number 410010
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Incheon, Korea, Republic of, 21565
- Investigational Site Number 410001
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Incheon, Korea, Republic of, 400-711
- Investigational Site Number 410009
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Jeonju, Korea, Republic of, 561-712
- Investigational Site Number 410011
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Seoul, Korea, Republic of, 03080
- Investigational Site Number 410007
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Seoul, Korea, Republic of, 04763
- Investigational Site Number 410012
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Seoul, Korea, Republic of, 120-752
- Investigational Site Number 410016
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Seoul, Korea, Republic of, 150-713
- Investigational Site Number 410003
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Suwon, Korea, Republic of, 443-721
- Investigational Site Number 410008
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Kaunas, Lithuania, 50009
- Investigational Site Number 440001
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Klaipeda, Lithuania, LT-92288
- Investigational Site Number 440006
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Vilnius, Lithuania, LT-08661
- Investigational Site Number 440002
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Vilnius, Lithuania, LT-08661
- Investigational Site Number 440007
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Ipoh, Malaysia, 30990
- Investigational Site Number 458001
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Kuching, Malaysia, 94300
- Investigational Site Number 458002
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Chihuahua, Mexico, 31000
- Investigational Site Number 484023
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Durango, Mexico, 34080
- Investigational Site Number 484008
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Guadalajara, Mexico, 44620
- Investigational Site Number 484018
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Guadalajara, Mexico, 44690
- Investigational Site Number 484002
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Leon, Mexico, 37000
- Investigational Site Number 484035
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Merida, Mexico, 97000
- Investigational Site Number 484009
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Metepec, Mexico, 52140
- Investigational Site Number 484007
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Mexicali, Mexico, 21200
- Investigational Site Number 484010
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Mexico City, Mexico, 6726
- Investigational Site Number 484003
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Monterrey, Mexico, 64000
- Investigational Site Number 484019
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Monterrey, Mexico, 64000
- Investigational Site Number 484020
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Monterrey, Mexico, 64460
- Investigational Site Number 484005
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Mérida, Mexico, 97070
- Investigational Site Number 484004
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México, Mexico, 06700
- Investigational Site Number 484017
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México, D.F., Mexico, 11850
- Investigational Site Number 484001
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Queretaro, Mexico, 76000
- Investigational Site Number 484021
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Amsterdam, Netherlands, 1056 AB
- Investigational Site Number 528010
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Christchurch, New Zealand, 8002
- Investigational Site Number 554004
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Nelson, New Zealand, 7010
- Investigational Site Number 554011
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Otahuhu, New Zealand, 2025
- Investigational Site Number 554007
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Rotorua, New Zealand, 3010
- Investigational Site Number 554002
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Timaru, New Zealand, 7910
- Investigational Site Number 554001
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Lima, Peru, 021
- Investigational Site Number 604001
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Lima, Peru, 14
- Investigational Site Number 604010
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Lima, Peru, 34
- Investigational Site Number 604008
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Lima, Peru, LIMA 01
- Investigational Site Number 604009
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Lima, Peru, LIMA 11
- Investigational Site Number 604006
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Lima, Peru, LIMA 11
- Investigational Site Number 604012
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Lima, Peru, LIMA 13
- Investigational Site Number 604013
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Lima, Peru, Lima 33
- Investigational Site Number 604007
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Lima, Peru, Lima 41
- Investigational Site Number 604005
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Cebu City, Philippines, 6000
- Investigational Site Number 608003
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Manila, Philippines, 1008
- Investigational Site Number 608001
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Bialystok, Poland, 15-099
- Investigational Site Number 616014
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Bialystok, Poland, 15-351
- Investigational Site Number 616002
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Bialystok, Poland, 15-879
- Investigational Site Number 616003
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Bydgoszcz, Poland, 85-168
- Investigational Site Number 616019
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Bytom, Poland, 41-902
- Investigational Site Number 616054
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Elblag, Poland, 82-300
- Investigational Site Number 616015
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Krakow, Poland, 30-510
- Investigational Site Number 616001
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Lublin, Poland, 20-582
- Investigational Site Number 616005
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Lublin, Poland, 20-954
- Investigational Site Number 616030
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Poznan, Poland, 61-397
- Investigational Site Number 616018
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Szczecin, Poland, 71-252
- Investigational Site Number 616016
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Torun, Poland, 87-100
- Investigational Site Number 616006
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Warszawa, Poland, 01-518
- Investigational Site Number 616031
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Warszawa, Poland, 02-118
- Investigational Site Number 616004
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Warszawa, Poland, 02-653
- Investigational Site Number 616017
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Wroclaw, Poland, 50-556
- Investigational Site Number 616020
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Wroclaw, Poland, 52-416
- Investigational Site Number 616012
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Lisboa, Portugal, 1050-034
- Investigational Site Number 620002
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Braila, Romania, 810019
- Investigational Site Number 642006
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Bucharest, Romania, 011171
- Investigational Site Number 642010
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Bucuresti, Romania, 010584
- Investigational Site Number 642021
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Bucuresti, Romania, 010976
- Investigational Site Number 642001
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Bucuresti, Romania, 020125
- Investigational Site Number 642020
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Bucuresti, Romania, 020983
- Investigational Site Number 642002
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Galati, Romania, 800578
- Investigational Site Number 642005
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Kemerovo, Russian Federation, 650000
- Investigational Site Number 643006
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Kemerovo, Russian Federation, 650066
- Investigational Site Number 643017
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Moscow, Russian Federation, 115404
- Investigational Site Number 643020
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Moscow, Russian Federation, 115522
- Investigational Site Number 643001
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Moscow, Russian Federation, 117997
- Investigational Site Number 643002
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Moscow, Russian Federation, 119049
- Investigational Site Number 643021
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Moscow, Russian Federation, 119333
- Investigational Site Number 643004
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Moscow, Russian Federation, 121359
- Investigational Site Number 643012
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Moscow, Russian Federation, 121374
- Investigational Site Number 643031
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Moscow, Russian Federation, 125284
- Investigational Site Number 643030
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Novosibirsk, Russian Federation, 630099
- Investigational Site Number 643009
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Ryazan, Russian Federation, 390026
- Investigational Site Number 643016
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Saint-Petersburg, Russian Federation, 192242
- Investigational Site Number 643008
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Samara, Russian Federation, 443095
- Investigational Site Number 643010
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Saratov, Russian Federation, 410053
- Investigational Site Number 643011
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St-Petersburg, Russian Federation, 190068
- Investigational Site Number 643007
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St-Petersburg, Russian Federation, 191186
- Investigational Site Number 643032
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St-Petersburg, Russian Federation, 196247
- Investigational Site Number 643014
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Ufa, Russian Federation, 450005
- Investigational Site Number 643013
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Cape Town, South Africa, 7405
- Investigational Site Number 710011
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Cape Town, South Africa, 7500
- Investigational Site Number 710007
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Cape Town, South Africa, 8001
- Investigational Site Number 710009
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Durban, South Africa, 4001
- Investigational Site Number 710003
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Durban, South Africa, 4091
- Investigational Site Number 710002
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Johannesburg, South Africa, 2013
- Investigational Site Number 710001
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Kempton Park, South Africa, 1619
- Investigational Site Number 710004
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Pretoria, South Africa, 0002
- Investigational Site Number 710005
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Pretoria, South Africa, 0084
- Investigational Site Number 710006
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Stellenbosch, South Africa, 7600
- Investigational Site Number 710010
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Barakaldo, Spain, 48903
- Investigational Site Number 724016
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Barcelona, Spain, 08034
- Investigational Site Number 724015
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Cádiz, Spain, 11009
- Investigational Site Number 724014
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La Coruña, Spain, 15006
- Investigational Site Number 724009
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Málaga, Spain, 29010
- Investigational Site Number 724001
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Sabadell, Spain, 08208
- Investigational Site Number 724011
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Santiago De Compostela, Spain, 15705
- Investigational Site Number 724012
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Santiago De Compostela, Spain, 15706
- Investigational Site Number 724013
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Sevilla, Spain, 41010
- Investigational Site Number 724022
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Sevilla, Spain, 41071
- Investigational Site Number 724007
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Uppsala, Sweden, 751 85
- Investigational Site Number 752002
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Taichung, Taiwan, 40201
- Investigational Site Number 158006
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Taoyuan County, Taiwan, 33305
- Investigational Site Number 158002
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Bangkok, Thailand, 10400
- Investigational Site Number 764001
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Bangkok, Thailand, 10700
- Investigational Site Number 764003
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Gaziantep, Turkey, 27310
- Investigational Site Number 792008
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Dnipro, Ukraine, 49047
- Investigational Site Number 804003
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Kharkiv, Ukraine, 61058
- Investigational Site Number 804010
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Kharkiv, Ukraine, 61176
- Investigational Site Number 804013
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Kyiv, Ukraine, 01103
- Investigational Site Number 804014
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Kyiv, Ukraine, 03680
- Investigational Site Number 804004
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Kyiv, Ukraine, 03680
- Investigational Site Number 804027
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Lviv, Ukraine, 79010
- Investigational Site Number 804005
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Simferopol, Ukraine, 95017
- Investigational Site Number 804006
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Vinnytsya, Ukraine, 21018
- Investigational Site Number 804011
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Zaporizhzhya, Ukraine, 69600
- Investigational Site Number 804009
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Doncaster, United Kingdom, DN2 5LT
- Investigational Site Number 826004
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Edinburgh, United Kingdom, EH4 2XU
- Investigational Site Number 826006
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Leytonstone, United Kingdom, E11 1NR
- Investigational Site Number 826002
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Southampton, United Kingdom, SO16 6YD
- Investigational Site Number 826005
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Alabama
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Anniston, Alabama, United States, 36207
- Investigational Site Number 840070
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Birmingham, Alabama, United States, 35205
- Investigational Site Number 840138
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Huntsville, Alabama, United States, 35801
- Investigational Site Number 840152
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Arizona
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Gilbert, Arizona, United States, 85234
- Investigational Site Number 840072
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Glendale, Arizona, United States, 85304
- Investigational Site Number 840141
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California
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Fullerton, California, United States, 92835
- Investigational Site Number 840134
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La Jolla, California, United States, 92093
- Investigational Site Number 840008
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San Diego, California, United States, 92120
- Investigational Site Number 840135
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Santa Maria, California, United States, 94354
- Investigational Site Number 840021
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Stanford, California, United States, 94305
- Investigational Site Number 840100
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Upland, California, United States, 91786
- Investigational Site Number 840049
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Colorado
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Colorado Springs, Colorado, United States, 80903
- Investigational Site Number 840151
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Delaware
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Lewes, Delaware, United States, 19958
- Investigational Site Number 840130
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Florida
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Aventura, Florida, United States, 33180
- Investigational Site Number 840153
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Clearwater, Florida, United States, 35765
- Investigational Site Number 840050
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Fort Lauderdale, Florida, United States, 33309
- Investigational Site Number 840033
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Gainesville, Florida, United States, 32608
- Investigational Site Number 840041
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Jupiter, Florida, United States, 33458
- Investigational Site Number 840067
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Miami, Florida, United States, 33155
- Investigational Site Number 840048
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Naples, Florida, United States, 34102
- Investigational Site Number 840024
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Orlando, Florida, United States, 32806
- Investigational Site Number 840006
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Ormond Beach, Florida, United States, 32174
- Investigational Site Number 840128
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Palm Harbor, Florida, United States, 34684
- Investigational Site Number 840063
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Palm Harbor, Florida, United States, 34684
- Investigational Site Number 840155
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Sarasota, Florida, United States, 34239
- Investigational Site Number 840060
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Tampa, Florida, United States, 33614
- Investigational Site Number 840140
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Vero Beach, Florida, United States, 32960
- Investigational Site Number 840126
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Georgia
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Atlanta, Georgia, United States, 30322
- Investigational Site Number 840003
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Decatur, Georgia, United States, 30033
- Investigational Site Number 840028
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Marietta, Georgia, United States, 30060
- Investigational Site Number 840027
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Investigational Site Number 840018
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Illinois
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Chicago, Illinois, United States, 60612
- Investigational Site Number 840046
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Kansas
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Kansas City, Kansas, United States, 66160-7321
- Investigational Site Number 840052
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Kentucky
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Elizabethtown, Kentucky, United States, 42701
- Investigational Site Number 840230
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Lexington, Kentucky, United States, 40504
- Investigational Site Number 840015
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Investigational Site Number 840120
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Lake Charles, Louisiana, United States, 70601
- Investigational Site Number 840109
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Maryland
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Frederick, Maryland, United States, 21702
- Investigational Site Number 840055
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Wheaton, Maryland, United States, 20902
- Investigational Site Number 840013
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Investigational Site Number 840154
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Michigan
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Lansing, Michigan, United States, 48910
- Investigational Site Number 840150
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Saint Clair Shores, Michigan, United States, 48081
- Investigational Site Number 840137
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Nebraska
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Lincoln, Nebraska, United States, 68516
- Investigational Site Number 840112
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New Jersey
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Freehold, New Jersey, United States, 07728
- Investigational Site Number 840026
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New York
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Lake Success, New York, United States, 11042
- Investigational Site Number 840115
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New York, New York, United States, 10003
- Investigational Site Number 840056
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New York, New York, United States, 11201
- Investigational Site Number 840043
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Orchard Park, New York, United States, 14127
- Investigational Site Number 840106
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Smithtown, New York, United States, 11787
- Investigational Site Number 840118
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North Carolina
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Wilmington, North Carolina, United States, 28401
- Investigational Site Number 840116
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North Dakota
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Minot, North Dakota, United States, 58701
- Investigational Site Number 840233
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- Investigational Site Number 840002
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Oklahoma City, Oklahoma, United States, 73103
- Investigational Site Number 840127
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Tulsa, Oklahoma, United States, 74104
- Investigational Site Number 840011
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Tulsa, Oklahoma, United States, 74135
- Investigational Site Number 840065
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18015
- Investigational Site Number 840010
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Duncansville, Pennsylvania, United States, 16635
- Investigational Site Number 840009
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Reading, Pennsylvania, United States, 19611
- Investigational Site Number 840062
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South Carolina
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Columbia, South Carolina, United States, 29204
- Investigational Site Number 840058
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North Charleston, South Carolina, United States, 29406
- Investigational Site Number 840016
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Tennessee
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Jackson, Tennessee, United States, 38305
- Investigational Site Number 840025
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Memphis, Tennessee, United States, 38119
- Investigational Site Number 840059
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Texas
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Amarillo, Texas, United States, 79124
- Investigational Site Number 840032
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Austin, Texas, United States, 78705
- Investigational Site Number 840038
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Dallas, Texas, United States, 75231
- Investigational Site Number 840001
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Dallas, Texas, United States, 75235
- Investigational Site Number 840022
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Dallas, Texas, United States, 75390
- Investigational Site Number 840012
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Houston, Texas, United States, 77074
- Investigational Site Number 840129
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Lubbock, Texas, United States, 79424
- Investigational Site Number 840069
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Mesquite, Texas, United States, 75150
- Investigational Site Number 840074
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Nassau Bay, Texas, United States, 77058
- Investigational Site Number 840020
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San Antonio, Texas, United States, 78217
- Investigational Site Number 840103
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Washington
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Spokane, Washington, United States, 99204
- Investigational Site Number 840036
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Tacoma, Washington, United States, 98405
- Investigational Site Number 840061
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West Virginia
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Clarksburg, West Virginia, United States, 26301
- Investigational Site Number 840124
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria :
Main study:
Participants with RA who were previously randomized in the sarilumab RA clinical program: e.g., the EFC11072 study, ACT11575 study, EFC10832 study, SFY13370, and EFC13752 study.
Sub-study:
Participants enrolled in the LTS11210 study who were receiving either sarilumab 200mg q2w PFS or sarilumab 150mg q2w PFS and who were able and willing to participate in this sub-study.
Participants who had been enrolled in the main study for at least 24 weeks. Participants must sign a sub-study written informed consent prior to any sub-study related procedure.
Exclusion criteria:
Main study:
Participants with any adverse event (AE) led to permanent study drug discontinuation from a prior study.
Participants with an abnormality(ies) or AEs that per investigator judgment would adversely affect participation of the participant in the study.
Sub-study: There are no additional exclusion criteria to those defined in main study.
The above information was 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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD)
Participants who completed any of initial studies:Part A or B of EFC11072, ACT11575, EFC10832 or SFY13370 were enrolled in LTS11210 and received sarilumab 150 milligrams (mg) subcutaneously (SC) once weekly (qw).
Dose could be reduced to 150 mg every 2 weeks (q2w) due to neutropenia, thrombocytopenia or increase in liver enzymes (alanine aminotransferase [ALT]).
After dose regimens selection for Phase 3 studies (150 mg q2w and 200 mg q2w), participants already receiving 150 mg qw were switched to sarilumab 200 mg q2w.
Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210.
Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks).
Participants who were already taking concomitant non-biologic DMARDs in initial study continued stable dose of one or combination of conventional synthetic DMARDs they were taking.
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Pharmaceutical form: solution Route of administration: subcutaneous |
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Experimental: Sarilumab monotherapy
Participants who completed study EFC13752 were enrolled in LTS11210 and received sarilumab 200 mg q2w.
Dose could be reduced to 150 mg q2w due to neutropenia, thrombocytopenia or increase in liver enzymes (ALT).
Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210.
Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks).
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Pharmaceutical form: solution Route of administration: subcutaneous |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: From first dose (i.e., Day 1 of study LTS11210) up to 60 days after last dose (maximum duration: up to 523 weeks)
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An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product and which did not necessarily have to have a causal relationship with the treatment.
An SAE was any untoward medical occurrence at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
TEAEs were AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the investigational medicinal product (IMP) in study LTS11210 to the last dose of the IMP +60 days).
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From first dose (i.e., Day 1 of study LTS11210) up to 60 days after last dose (maximum duration: up to 523 weeks)
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Sub-study: Number of Participants Reported Product Technical Complaints (PTC), Product Technical Failures (PTF) and/or Failed Drug Deliveries (FDD) With Pre-filled Syringe With Safety System
Time Frame: From Week 24 to 36
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A PTF was defined as any product technical complaint (PTC) related to the use of the PFS-S that had a validated technical cause.
FDD was defined as participant's failure to administer the full dose at a given attempt.
A PTC was defined as any participant- or healthcare provider-reported complaint regarding the use of the PFS-S syringe and collected via the completion of the injection diary.
The injection diary comprised specific questions: 1. Were you able to remove the cap? 2. Was the needle safety system activated?, 3. Did the safety system entirely cover the needle, and 4. Was the person who performed the injection the person who was trained by the site staff?, where each question was given the option yes/no.
Participants who answered "no" for any of the questions of PTC, had PTF and/or FDD were reported in this outcome measure.
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From Week 24 to 36
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Sub-study: Number of Product Technical Complaints - Product Technical Failures With Pre-filled Syringe With Safety System
Time Frame: From Week 24 to 36
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A PTF was defined as any PTC (defined as any participant- or healthcare provider-reported complaint regarding the use of the PFS-S syringe and collected via the completion of the injection diary) related to the use of the PFS-S that had a validated technical cause.
Number of PTF in the participants enrolled in sub-study were reported in this outcome measure.
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From Week 24 to 36
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Sub-study: Number of Failed Drug Deliveries Associated With Pre-filled Syringe With Safety System
Time Frame: From Week 24 to 36
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FDD was defined as participant's failure to administer the full dose at a given attempt.
Number of FDD in the participants enrolled in sub-study were reported in this outcome measure.
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From Week 24 to 36
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Sub-study: Number of Product Technical Complaints With Pre-filled Syringe With Safety System
Time Frame: From Week 24 to 36
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A PTC was defined as any participant- or healthcare provider-reported complaint regarding the use of the PFS-S syringe and collected via the completion of the injection diary.
The injection diary comprised specific questions: 1. Were you able to remove the cap? 2. Was the needle safety system activated?, 3. Did the safety system entirely cover the needle, and 4. Was the person who performed the injection the person who was trained by the site staff?, where each question was given the option yes/no.
Number of PTC (based on participant's answer to "no" for any of the questions of PTC) in the participants enrolled in sub-study were reported in this outcome measure.
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From Week 24 to 36
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response
Time Frame: At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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ACR20 response: greater than or equal to (>=) 20% improvement in both tender joint count and swollen joint count and, >=20% improvement in at least 3 of the 5 remaining ACR core measures assessments: C-reactive protein [CRP] level (mg/liter [mg/L]); participant's assessment of pain (measured on 0 [no pain] to 100 mm [worst pain] visual analog scale [VAS]); participant's global assessment of disease activity (measured on 0 [no arthritis activity] to 100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity] to 100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by health assessment questionnaire disability index [HAQ-DI], with scoring range of 0 [better physical function] to 3 [worst physical function]).
Higher score indicated worse outcomes.
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At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response
Time Frame: At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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ACR50 response: >=50% improvement in both TJC and SJC, and >=50% improvement in at least 3 of the 5 remaining ACR core measures assessments: CRP level (in mg/L); participant's assessment of pain (measured on 0 [no pain] to 100 mm [worst pain] VAS); participant's global assessment of disease activity (measured on 0 [no arthritis activity] to 100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity] to 100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by HAQ-DI, with scoring range of 0 [better physical function] to 3 [worst physical function]).
Higher score indicated worse outcomes.
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At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response
Time Frame: At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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ACR70 response: >=70% improvement in both TJC and SJC, and >=70% improvement in at least 3 of the 5 remaining ACR core measures assessments: CRP level (in mg/L); participant's assessment of pain (measured on 0 [no pain] to 100 mm [worst pain] VAS); participant's global assessment of disease activity (measured on 0 [no arthritis activity]to 100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity] to 100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by HAQ-DI, with scoring range of 0 [better physical function] to 3 [worst physical function]).
Higher score indicated worse outcomes.
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At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Percentage of Participants With Disease Activity Score for 28 Joints (DAS28) Remission
Time Frame: At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210
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Disease activity score based on 28 joints and C-reactive protein (DAS28-CRP) was a composite score which included 4 components: TJC with 28 joints assessed; SJC with 28 joints assessed; high-sensitivity CRP (in mg/L) and general health assessment by the participant using participant global assessment (measured on 0 [no arthritis activity] to 100 mm [maximal arthritis activity] VAS).
DAS28-CRP total score ranges from 0 to 10, where higher scores indicated greater disease activity.
Percentage of participants with DAS28 remission were reported.
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At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210
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Percentage of Participants Achieving Good Response, Moderate Response or Non-response Using the European League Against Rheumatism (EULAR) Response Criteria
Time Frame: At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210
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DAS28-based EULAR response criteria were used to measure individual response as none, good or moderate, depending on the extent of change from baseline and level of disease activity reached. The EULAR response criteria are defined as:
Scores of good and moderate were considered to indicate therapeutic response. DAS28-CRP is a composite score which included 4 components: TJC with 28 joints assessed; SJC with 28 joints assessed; high-sensitivity CRP (in mg/L) and general health assessment by participant using participant global assessment (measured on 0 [no arthritis activity] to 100 mm [maximal arthritis activity] VAS. |
At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210
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Change From Baseline in DAS28-CRP Score at Weeks 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210
Time Frame: Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210
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DAS28-CRP is a composite score which included 4 components: TJC with 28 joints assessed; SJC with 28 joints assessed; high-sensitivity CRP (in mg/L) and general health assessment by the participant using participant global assessment (measured on 0 [no arthritis activity] to 100 mm [maximal arthritis activity] VAS).
DAS28-CRP total score ranges from 0-10, where higher scores indicated greater disease activity.
Here, Baseline refers to the Baseline of initial studies (EFC11072, ACT11575, EFC10832, SFY13370 and EFC13752).
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Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Time Frame: Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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HAQ-DI is a standardized questionnaire used to assess the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming; arising; eating; walking; hygiene; reach; grip and activities.
There were total of 30 items distributed in these 8 domains.
Each item was scored on a 4-point scale from 0 to 3, where 0= no difficulty in physical function; 1= some difficulty in physical function; 2= much difficulty in physical function; 3= unable to do.
Overall score was computed as the sum of domain scores and divided by the number of domains answered.
Total possible score range 0 (least difficulty in physical function) to 3 (extreme difficulty in physical function), where higher scores indicate more difficulty while performing daily living activities.
Here, Baseline refers to the Baseline of initial studies (EFC11072, ACT11575, EFC10832, SFY13370 and EFC13752).
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Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 0 and Week 48 of LTS11210: Campaign 1 X-ray Data - Participants From EFC11072 Part B
Time Frame: Baseline, Week 0 and 48 of LTS11210
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Van der Heijde modified Sharp method is composite X-ray scoring system used to assess structural (joint) disease progression in RA.
The method evaluates both joint erosions (JE) for 44 joints and joint space narrowing (JSN) for 42 joints in bilateral hand and foot joints.
Total mTSS: sum of the scores from both erosion score and joint space narrowing score and ranged from 0 (normal, no progression) to 448 (worst possible total score).
An increase in total score represents progression of structural damage.
Here, Baseline refers to the Baseline of initial study (EFC11072 Part B).
In this outcome measure, change from initial study Baseline in 2 years X-ray data at Week 0 and 48 of LTS11210 were reported.
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Baseline, Week 0 and 48 of LTS11210
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Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 48 and Week 96 of LTS11210: Campaign 2 X-ray Data - Participants From EFC11072 Part B
Time Frame: Baseline, Week 48 and 96 of LTS11210
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Van der Heijde modified Sharp method is composite X-ray scoring system used to assess structural (joint) disease progression in RA.
The method evaluates both JE for 44 joints and JSN for 42 joints in bilateral hand and foot joints.
Total mTSS: sum of the scores from both erosion score and joint space narrowing score and ranged from 0 (normal, no progression) to 448 (worst possible total score).
An increase in total score represents progression of structural damage.
Here, Baseline refers to the Baseline of initial study (EFC11072 Part B).
In this outcome measure, change from initial study (EFC11072 Part B) Baseline in 3 years X-ray data (participants with study duration of more than 48 weeks in LTS11210) at Week 48 and 96 of LTS11210 from Campaign 2 were reported.
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Baseline, Week 48 and 96 of LTS11210
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Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 96, Week 144 and Week 192 of LTS11210: Campaign 3 X-ray Data - Participants From EFC11072 Part B
Time Frame: Baseline, Week 96, 144 and 192 of LTS11210
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Van der Heijde modified Sharp method is composite X-ray scoring system used to assess structural (joint) disease progression in RA.
The method evaluates both JE for 44 joints and JSN for 42 joints in bilateral hand and foot joints.
Total mTSS: sum of the scores from both erosion score and joint space narrowing score and ranged from 0 (normal, no progression) to 448 (worst possible total score).
An increase in total score represents progression of structural damage.
Here, Baseline refers to the Baseline of initial study (EFC11072 Part B).
In this outcome measure, change from initial study (EFC11072 Part B) Baseline in 5 years X-ray data (participants with study duration of more than 96 weeks in LTS11210) at Week 96, 144 and 192 of LTS11210 from Campaign 3 were reported.
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Baseline, Week 96, 144 and 192 of LTS11210
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Percentage of Participants With no Radiographic Progression of the Van Der Heijde Modified Total Sharp Score at Week 0 and 48 of LTS11210: Campaign 1 X-ray Data - Participants From EFC11072 Part B
Time Frame: Week 0 (post-dose) and 48 of LTS11210
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Radiographic no progression: defined as a change from Baseline in Van der Heijde mTSS <= 0. Van der Heijde modified Sharp method is composite X-ray scoring system used to assess structural (joint) disease progression in RA.
The method evaluates both JE for 44 joints and JSN for 42 joints in bilateral hand and foot joints.
Total mTSS was sum of scores from both erosion score and joint space narrowing score, ranged from 0 (normal, no progression) to 448 (worst possible total score).
Increase in total score represents progression of structural damage.
In this outcome measure, percentage of participants with no radiographic progression at Week 48 of LTS11210 from Campaign 1 X-ray data were reported.
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Week 0 (post-dose) and 48 of LTS11210
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Percentage of Participants With no Radiographic Progression of the Van Der Heijde Modified Total Sharp Score at Week 48 and Week 96 of LTS11210: Campaign 2 X-ray Data - Participants From EFC11072 Part B
Time Frame: Week 48 and 96 of LTS11210
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Radiographic no progression: defined as a change from Baseline in Van der Heijde mTSS <= 0. Van der Heijde modified Sharp method is composite X-ray scoring system used to assess structural (joint) disease progression in RA.
The method evaluates both JE for 44 joints and JSN for 42 joints in bilateral hand and foot joints.
Total mTSS was sum of scores from both erosion score and joint space narrowing score, ranged from 0 (normal, no progression) to 448 (worst possible total score).
Increase in total score represents progression of structural damage.
In this outcome measure, percentage of participants with no radiographic progression at Week 48 and 96 of LTS11210 from Campaign 2 X-ray data (participants with study duration of more than 48 weeks in LTS11210) were reported.
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Week 48 and 96 of LTS11210
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Percentage of Participants With no Radiographic Progression of the Van Der Heijde Modified Total Sharp Score at Week 96, 144 and 192 of LTS11210: Campaign 3 X-ray Data - Participants From EFC11072 Part B
Time Frame: Week 96, 144 and 192 of LTS11210
|
Radiographic no progression: defined as a change from Baseline in Van der Heijde mTSS <= 0. Van der Heijde modified Sharp method is composite X-ray scoring system used to assess structural (joint) disease progression in RA.
The method evaluates both JE for 44 joints and JSN for 42 joints in bilateral hand and foot joints.
Total mTSS was sum of scores from both erosion score and joint space narrowing score, ranged from 0 (normal, no progression) to 448 (worst possible total score).
Increase in total score represents progression of structural damage.
In this outcome measure, percentage of participants with no radiographic progression at Week 96, 144 and 192 of LTS11210 from Campaign 3 X-ray data (participants with study duration more than 96 weeks in LTS11210) were reported.
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Week 96, 144 and 192 of LTS11210
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Change From Baseline in Tender Joint Count (TJC) at Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210
Time Frame: Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210
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TJC is the sum of all tender joints based on examination of the 68 joints of the fingers, elbows, hips, knees, ankles, and toes.
Total TJC ranged from 0 (best) to 68 (worst), where higher score = more severity.
Change from Baseline in TJC was reported in the outcome measure.
Here, Baseline refers to Baseline of initial study (EFC11072, ACT11575, EFC10832, SFY13370 and EFC13752).
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Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210
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Change From Baseline in Swollen Joint Count (SJC) at Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210
Time Frame: Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210
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SJC is the sum of all swollen joints based on examination of the fingers, elbows, knees and toes.
Total SJC ranged from 0 (best) to 66 (worst), where higher score = more severity.
Change from Baseline in SJC was reported in the outcome measure.
Here, Baseline refers to the Baseline of initial studies (EFC11072, ACT11575, EFC10832, SFY13370 and EFC13752).
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Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210
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Change From Baseline in Physician's Global Assessments of Disease Activity Visual Analogue Scale (VAS) Score at Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, and 264 of LTS11210
Time Frame: Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, and 264 of LTS11210
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Physician global assessment of disease activity was measured on a 100 millimeters (mm) horizontal VAS, ranging from 0 (best disease activity) to 100 (worst disease activity), where lower score = less disease activity and higher score = more disease activity.
Here, Baseline refers to Baseline of initial studies (EFC11072, ACT11575, EFC10832, SFY13370 and EFC13752).
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Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, and 264 of LTS11210
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Change From Baseline in Participant Global Assessment of Disease Activity Visual Analogue Scale Score at Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210
Time Frame: Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210
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Participant global assessment of disease activity was measured on a 100 mm horizontal VAS, ranging from 0 (best disease activity) to 100 (worst disease activity), where lower score = less disease activity and higher score = more disease activity.
Here, Baseline refers to the Baseline of initial studies (EFC11072, ACT11575, EFC10832, SFY13370 and EFC13752).
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Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210
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Change From Baseline in Participant's Assessment of Pain Visual Analogue Scale Score at Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, and 264 of LTS11210
Time Frame: Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, and 264 of LTS11210
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Participants were requested to indicate their pain intensity due to their RA on a 100 mm horizontal VAS, ranging from 0 (no pain) to 100 (worst pain), where a higher score represented more pain due to RA.
Here, Baseline refers to the Baseline of initial studies (EFC11072, ACT11575, EFC10832, SFY13370 and EFC13752).
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Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, and 264 of LTS11210
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Change From Baseline in Short Form 36 (SF-36; Version 2) Physical Component Summary (PCS) Score at Week 0, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 - Participants From EFC11072, ACT11575 and EFC10832 Only
Time Frame: Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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SF-36 is a generic 36-item questionnaire consisting of 8 domains, measuring quality of life (QoL) covering 2 summary measures: PCS and mental component summary (MCS).
PCS with 4 domains: physical functioning, role limitations due to physical problems, bodily pain, and general health; and MCS with 4 domains: vitality, social functioning, role limitations due to emotional problems, and mental health.
Each domain is scored by summing the individual items, which are transformed into a score range from 0 to 100; where 0= worst QoL to 100=best QoL.
PCS total score ranged from 0 to 100 with higher scores indicating better physical health.
Here, Baseline refers to the Baseline of initial studies (EFC11072, ACT11575, and EFC10832).
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Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Change From Baseline in Short Form 36 (SF-36; Version 2) Mental Component Summary Score at Week 0, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 - Participants From EFC11072, ACT11575 and EFC10832 Only
Time Frame: Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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SF-36 is a generic 36-item questionnaire consisting of 8 domains, measuring quality of life (QoL) covering 2 summary measures: PCS and MCS.
PCS with 4 domains: physical functioning, role limitations due to physical problems, bodily pain, and general health; and MCS with 4 domains: vitality, social functioning, role limitations due to emotional problems, and mental health.
Each domain is scored by summing the individual items, which are transformed into a score range from 0 to 100; 0= worst QoL to 100=best QoL.
MCS total score ranged from 0 to 100 with higher scores indicating better physical and mental health.
Here, Baseline refers to the Baseline of initial studies (EFC11072, ACT11575, and EFC10832).
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Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-fatigue) Total Score at Week 0, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210-Participants From EFC11072, ACT11575 and EFC10832 Only
Time Frame: Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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The FACIT-F is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0 to 4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much.
The sum of all responses resulted in the FACIT-Fatigue total score ranged from 0 to 52, where higher score = lower level of fatigue and indicates better QoL.
A positive change from baseline score indicates an improvement.
Here, Baseline refers to the Baseline of initial studies (EFC11072, ACT11575, and EFC10832).
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Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Change From Baseline in Sleep Visual Analogue Scale Score at Week 0, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 - Participants From EFC11072, and ACT11575 Only
Time Frame: Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Rheumatoid arthritis (RA), like other chronic illness, is associated with sleep disturbances and is linked to pain, mood, and disease activity.
The effect of sarilumab on sleep was assessed on a on 100 mm horizontal VAS scale, ranging from 0 (sleep is not a problem) to 100 (sleep is a major problem), where higher score = more sleep disturbances.
Here, Baseline refers to the Baseline of initial studies (EFC11072, and ACT11575).
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Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Due to RA at Week 0, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 - Participants From EFC11072 and ACT11575 Only
Time Frame: Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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WPAI assesses work productivity and impairment.
It is 6-item questionnaire used to assess degree to which RA affected work productivity and regular activities over past 7 days.
Questions were: Q1 = currently employed; Q2 = hours missed due to RA; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree problem affected productivity while working (0 to 10 scale, with higher numbers indicated less productivity); Q6 = degree problem affected regular activities (0 to 10 scale, with higher numbers indicated greater impairment).
The percent work time missed due to RA was a subscale and calculated as: 100*Q2/(Q2+Q4) for those who were currently employed.
Subscale score was expressed as impairment percentage (range:0 to 100%) where higher numbers indicate greater impairment and less productivity.
Here, Baseline refers to Baseline of initial studies (EFC11072 and ACT11575).
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Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Change From Baseline in Work Productivity and Activity Impairment: Percent Impairment While Working Due to RA at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 - Participants From EFC11072, and ACT11575 Only
Time Frame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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WPAI assesses work productivity and impairment.
It is 6-item questionnaire used to assess degree to which RA affected work productivity and regular activities over past 7 days.
Questions were: Q1 = currently employed; Q2 = hours missed due to RA; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree problem affected productivity while working (0 to 10 scale, with higher numbers = less productivity); Q6 = degree problem affected regular activities (0 to 10 scale, with higher numbers = greater impairment).
Percentage impairment while working due to RA was subscale and calculated as: 10*Q5 for those who were currently employed and actually worked in past 7 days.
Subscale score=expressed as impairment percentage (range:0 to 100%), where higher numbers=greater impairment and less productivity.
Here, Baseline refers to the Baseline of initial studies (EFC11072 and ACT11575).
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Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Change From Baseline in Work Productivity and Activity Impairment: Percent Overall Work Impairment Due to RA at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 - Participants From EFC11072, and ACT11575 Only
Time Frame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
|
WPAI assesses work productivity and impairment.
It is 6-item questionnaire used to assess degree to which RA affected work productivity and regular activities over past 7 days.
Questions were: Q1 = currently employed; Q2 = hours missed due to RA; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree problem affected productivity while working (0 to 10 scale, with higher numbers indicated less productivity); Q6 = degree problem affected regular activities (0 10 scale, with higher numbers indicated greater impairment).
Percent overall work impairment due to RA was subscale and calculated as: 100*Q2/(Q2+Q4)+100*[(1- Q2/(Q2+Q4))*(Q5/10)] for those who were currently employed .
Subscale score = expressed as impairment percentage (range: 0 to 100%) where higher numbers indicate greater impairment.
Here, Baseline refers to Baseline of initial studies (EFC11072 and ACT11575).
|
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Change From Baseline in Work Productivity and Activity Impairment: Percent Activity Impairment Due to RA at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 - Participants From EFC11072, and ACT11575 Only
Time Frame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
|
WPAI assesses work productivity and impairment.
It is 6-item questionnaire used to assess degree to which RA affected work productivity and regular activities over past 7 days.
Questions were: Q1 = currently employed; Q2 = hours missed due to RA; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree problem affected productivity while working (0 to 10 scale, with higher numbers indicated less productivity); Q6 = degree problem affected regular activities (0 10 scale, with higher numbers indicated greater impairment).
Percent activity impairment due to RA was a subscale and calculated as: 10*Q6 for all respondents.
Subscale score=expressed as impairment percentage (range: 0 to 100%) where higher numbers indicate greater impairment.
Here, Baseline refers to Baseline of initial studies (EFC11072 and ACT11575).
|
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Change From Baseline in Work Productivity Survey - Rheumatoid Arthritis (WPS-RA) at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210: Work Days Missed Due to Arthritis - Participants From EFC10832 Only
Time Frame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with arthritis over the previous month.
The questionnaire was interviewer-administered and was based on participant self-report.
It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items).
Change from Baseline in number of work days missed in the last month due to arthritis by the participant was reported in the outcome measure.
Here, Baseline refers to the Baseline of initial study (EFC10832).
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Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Change From Baseline in WPS-RA at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210: Days With Work Productivity Reduced by >=50% Due to Arthritis - Participants From EFC10832 Only
Time Frame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
|
The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month.
The questionnaire was interviewer-administered and was based on participant self-report.
It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items).
Change from Baseline in number of work days with reduced productivity by >= 50% in the last month by the participant was reported in the outcome measure.
Here, Baseline refers to the Baseline of initial study (EFC10832).
|
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Change From Baseline in WPS-RA at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210: Arthritis Interference With Work Productivity - Participants From EFC10832 Only
Time Frame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
|
The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month.
The questionnaire was interviewer-administered and was based on participant self-report.
It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items).
Interference in the last month with work productivity was measured on a scale that ranged from 0 (no interference) to 10 (complete interference), where higher scores indicated more interference.
Here, Baseline refers to the Baseline of initial study (EFC10832).
|
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
|
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Change From Baseline in WPS-RA at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210: House Work Days Missed Due to Arthritis - Participants From EFC10832 Only
Time Frame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
|
'The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month.
The questionnaire was interviewer-administered and was based on participant self-report.
It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items).
Change from baseline in number of days with no household work/household work missed in the last month by the participants was reported.
Here, Baseline refers to the Baseline of initial study (EFC10832).
|
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
|
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Change From Baseline in WPS-RA at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210: Days With Household Work Productivity Reduced by >=50% Due to Arthritis - Participants From EFC10832 Only
Time Frame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
|
The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month.
The questionnaire was interviewer-administered and was based on participant self-report.
It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items).
Change from baseline in number of days with reduced household work productivity by >= 50% in the last month by the participants was reported.
Here, Baseline refers to the Baseline of initial study (EFC10832).
|
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Change From Baseline in WPS-RA at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210: Days With Family/Social/Leisure Activities Missed Due to Arthritis - Participants From EFC10832 Only
Time Frame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
|
The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month.
The questionnaire was interviewer-administered and was based on participant self-report.
It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items).
Change from baseline in number of days missed of family/social/leisure activities in the last month by the participants was reported.
Here, Baseline refers to the Baseline of initial study (EFC10832).
|
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
|
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Change From Baseline in WPS-RA at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210: Days With Outside Help Hired Due to Arthritis- Participants From EFC10832 Only
Time Frame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
|
The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month.
The questionnaire was interviewer-administered and was based on participant self-report.
It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items).
Change from baseline in number of days with outside help hired in the last month by the participant was reported.
Here, Baseline refers to the Baseline of initial study (EFC10832).
|
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
|
|
Change From Baseline in WPS-RA at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210: Arthritis Interference With Household Work Productivity - Participants From EFC10832 Only
Time Frame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
|
The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month.
The questionnaire was interviewer-administered and was based on participant self-report.
It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items).
The RA interference in the last month with household work productivity was measured on a scale that ranged from 0 (no interference) to 10 (complete interference), where higher scores indicated more interference.
Here, Baseline refers to the Baseline of initial study (EFC10832).
|
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
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Sub-study: Number of Participants Who Reported Adverse Events Related to Pre-filled Syringe With Safety System
Time Frame: From Week 24 to 36
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AEs related to PFS-S included PTC-related AEs, device-related AEs, or AEs of injection site reaction.
In this outcome measure, only PTC-related AEs, device-related AEs, or AEs of injection site reaction assessed during the sub-study were reported.
TEAEs and SAEs reported during the sub-study were included in the main study data and no separate data collection and analysis was performed, as pre-planned in the protocol .
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From Week 24 to 36
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
- Fleischmann R, Genovese MC, Maslova K, Leher H, Praestgaard A, Burmester GR. Long-term safety and efficacy of sarilumab over 5 years in patients with rheumatoid arthritis refractory to TNF inhibitors. Rheumatology (Oxford). 2021 Nov 3;60(11):4991-5001. doi: 10.1093/rheumatology/keab355.
- Emery P, van Hoogstraten H, Thangavelu K, Mangan E, St John G, Verschueren P. Subcutaneous Sarilumab in Patients With Rheumatoid Arthritis who Previously Received Subcutaneous Sarilumab or Intravenous Tocilizumab: An Open-Label Extension of a Randomized Clinical Trial. ACR Open Rheumatol. 2020 Nov;2(11):672-680. doi: 10.1002/acr2.11188. Epub 2020 Nov 8.
- Genovese MC, van der Heijde D, Lin Y, St John G, Wang S, van Hoogstraten H, Gomez-Reino JJ, Kivitz A, Maldonado-Cocco JA, Seriolo B, Stanislav M, Burmester GR. Long-term safety and efficacy of sarilumab plus methotrexate on disease activity, physical function and radiographic progression: 5 years of sarilumab plus methotrexate treatment. RMD Open. 2019 Aug 1;5(2):e000887. doi: 10.1136/rmdopen-2018-000887. eCollection 2019.
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 (Actual)
June 21, 2010
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
June 15, 2010
First Submitted That Met QC Criteria
June 16, 2010
First Posted (Estimate)
June 17, 2010
Study Record Updates
Last Update Posted (Actual)
March 28, 2022
Last Update Submitted That Met QC Criteria
March 21, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LTS11210
- 2010-019262-86 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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.