Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)
2 other identifiers
interventional
2,023
37 countries
324
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Jun 2010
Longer than P75 for phase_3 rheumatoid-arthritis
324 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2010
CompletedFirst Posted
Study publicly available on registry
June 17, 2010
CompletedStudy Start
First participant enrolled
June 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedResults Posted
Study results publicly available
January 24, 2022
CompletedMarch 28, 2022
March 1, 2022
10.5 years
June 15, 2010
December 24, 2021
March 21, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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).
From first dose (i.e., Day 1 of study LTS11210) up to 60 days after last dose (maximum duration: up to 523 weeks)
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
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.
From Week 24 to 36
Sub-study: Number of Product Technical Complaints - Product Technical Failures With Pre-filled Syringe With Safety System
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.
From Week 24 to 36
Sub-study: Number of Failed Drug Deliveries Associated With Pre-filled Syringe With Safety System
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.
From Week 24 to 36
Sub-study: Number of Product Technical Complaints With Pre-filled Syringe With Safety System
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.
From Week 24 to 36
Secondary Outcomes (35)
Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response
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
Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response
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
Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response
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
Percentage of Participants With Disease Activity Score for 28 Joints (DAS28) Remission
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
Percentage of Participants Achieving Good Response, Moderate Response or Non-response Using the European League Against Rheumatism (EULAR) Response Criteria
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
- +30 more secondary outcomes
Study Arms (2)
Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD)
EXPERIMENTALParticipants 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.
Sarilumab monotherapy
EXPERIMENTALParticipants 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).
Interventions
Pharmaceutical form: solution Route of administration: subcutaneous
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Regeneron Pharmaceuticalscollaborator
Study Sites (335)
Investigational Site Number 840070
Anniston, Alabama, 36207, United States
Investigational Site Number 840138
Birmingham, Alabama, 35205, United States
Investigational Site Number 840152
Huntsville, Alabama, 35801, United States
Investigational Site Number 840072
Gilbert, Arizona, 85234, United States
Investigational Site Number 840141
Glendale, Arizona, 85304, United States
Investigational Site Number 840134
Fullerton, California, 92835, United States
Investigational Site Number 840008
La Jolla, California, 92093, United States
Investigational Site Number 840135
San Diego, California, 92120, United States
Investigational Site Number 840021
Santa Maria, California, 94354, United States
Investigational Site Number 840100
Stanford, California, 94305, United States
Investigational Site Number 840049
Upland, California, 91786, United States
Investigational Site Number 840151
Colorado Springs, Colorado, 80903, United States
Investigational Site Number 840130
Lewes, Delaware, 19958, United States
Investigational Site Number 840153
Aventura, Florida, 33180, United States
Investigational Site Number 840050
Clearwater, Florida, 35765, United States
Investigational Site Number 840033
Fort Lauderdale, Florida, 33309, United States
Investigational Site Number 840041
Gainesville, Florida, 32608, United States
Investigational Site Number 840067
Jupiter, Florida, 33458, United States
Investigational Site Number 840048
Miami, Florida, 33155, United States
Investigational Site Number 840024
Naples, Florida, 34102, United States
Investigational Site Number 840006
Orlando, Florida, 32806, United States
Investigational Site Number 840128
Ormond Beach, Florida, 32174, United States
Investigational Site Number 840063
Palm Harbor, Florida, 34684, United States
Investigational Site Number 840155
Palm Harbor, Florida, 34684, United States
Investigational Site Number 840060
Sarasota, Florida, 34239, United States
Investigational Site Number 840140
Tampa, Florida, 33614, United States
Investigational Site Number 840126
Vero Beach, Florida, 32960, United States
Investigational Site Number 840003
Atlanta, Georgia, 30322, United States
Investigational Site Number 840028
Decatur, Georgia, 30033, United States
Investigational Site Number 840027
Marietta, Georgia, 30060, United States
Investigational Site Number 840018
Idaho Falls, Idaho, 83404, United States
Investigational Site Number 840046
Chicago, Illinois, 60612, United States
Investigational Site Number 840052
Kansas City, Kansas, 66160-7321, United States
Investigational Site Number 840230
Elizabethtown, Kentucky, 42701, United States
Investigational Site Number 840015
Lexington, Kentucky, 40504, United States
Investigational Site Number 840120
Baton Rouge, Louisiana, 70809, United States
Investigational Site Number 840109
Lake Charles, Louisiana, 70601, United States
Investigational Site Number 840055
Frederick, Maryland, 21702, United States
Investigational Site Number 840013
Wheaton, Maryland, 20902, United States
Investigational Site Number 840154
Boston, Massachusetts, 02115, United States
Investigational Site Number 840150
Lansing, Michigan, 48910, United States
Investigational Site Number 840137
Saint Clair Shores, Michigan, 48081, United States
Investigational Site Number 840112
Lincoln, Nebraska, 68516, United States
Investigational Site Number 840026
Freehold, New Jersey, 07728, United States
Investigational Site Number 840115
Lake Success, New York, 11042, United States
Investigational Site Number 840056
New York, New York, 10003, United States
Investigational Site Number 840043
New York, New York, 11201, United States
Investigational Site Number 840106
Orchard Park, New York, 14127, United States
Investigational Site Number 840118
Smithtown, New York, 11787, United States
Investigational Site Number 840116
Wilmington, North Carolina, 28401, United States
Investigational Site Number 840233
Minot, North Dakota, 58701, United States
Investigational Site Number 840002
Oklahoma City, Oklahoma, 73103, United States
Investigational Site Number 840127
Oklahoma City, Oklahoma, 73103, United States
Investigational Site Number 840011
Tulsa, Oklahoma, 74104, United States
Investigational Site Number 840065
Tulsa, Oklahoma, 74135, United States
Investigational Site Number 840010
Bethlehem, Pennsylvania, 18015, United States
Investigational Site Number 840009
Duncansville, Pennsylvania, 16635, United States
Investigational Site Number 840062
Reading, Pennsylvania, 19611, United States
Investigational Site Number 840058
Columbia, South Carolina, 29204, United States
Investigational Site Number 840016
North Charleston, South Carolina, 29406, United States
Investigational Site Number 840025
Jackson, Tennessee, 38305, United States
Investigational Site Number 840059
Memphis, Tennessee, 38119, United States
Investigational Site Number 840032
Amarillo, Texas, 79124, United States
Investigational Site Number 840038
Austin, Texas, 78705, United States
Investigational Site Number 840001
Dallas, Texas, 75231, United States
Investigational Site Number 840022
Dallas, Texas, 75235, United States
Investigational Site Number 840012
Dallas, Texas, 75390, United States
Investigational Site Number 840129
Houston, Texas, 77074, United States
Investigational Site Number 840069
Lubbock, Texas, 79424, United States
Investigational Site Number 840074
Mesquite, Texas, 75150, United States
Investigational Site Number 840020
Nassau Bay, Texas, 77058, United States
Investigational Site Number 840103
San Antonio, Texas, 78217, United States
Investigational Site Number 840036
Spokane, Washington, 99204, United States
Investigational Site Number 840061
Tacoma, Washington, 98405, United States
Investigational Site Number 840124
Clarksburg, West Virginia, 26301, United States
Investigational Site Number 032006
Caba, C1015ABO, Argentina
Investigational Site Number 032007
Caba, C1055AAF, Argentina
Investigational Site Number 032008
Caba, C1428DZF, Argentina
Investigational Site Number 032019
Capital Federal, 1180, Argentina
Investigational Site Number 032016
Capital Federal, 1425, Argentina
Investigational Site Number 032002
Córdoba, X5004BAL, Argentina
Investigational Site Number 032020
Córdoba, X5016KEH, Argentina
Investigational Site Number 032003
Córdoba, Argentina
Investigational Site Number 032017
La Plata, B1902, Argentina
Investigational Site Number 032012
Mar del Plata, B7600FZN, Argentina
Investigational Site Number 032011
Quilmes, B1878DVB, Argentina
Investigational Site Number 032010
Ramos Mejía, B1704ETD, Argentina
Investigational Site Number 032001
Rosario, 2000, Argentina
Investigational Site Number 032013
Rosario, S2000PBJ, Argentina
Investigational Site Number 032015
San Fernando, 1646, Argentina
Investigational Site Number 032005
San Miguel de Tucumán, 4000, Argentina
Investigational Site Number 032004
San Miguel de Tucumán, T4000AXL, Argentina
Investigational Site Number 032009
Zárate, B2800DGH, Argentina
Investigational Site Number 036003
Camperdown, 2050, Australia
Investigational Site Number 036012
Fitzroy, 3065, Australia
Investigational Site Number 036010
Garran, 2605, Australia
Investigational Site Number 036004
Heidelberg West, 3081, Australia
Investigational Site Number 036001
Maroochydore, 4558, Australia
Investigational Site Number 036014
Victoria Park, 6100, Australia
Investigational Site Number 036007
Woodville, 5011, Australia
Investigational Site Number 040001
Graz, 8036, Austria
Investigational Site Number 112002
Minsk, 220037, Belarus
Investigational Site Number 112001
Minsk, 220116, Belarus
Investigational Site Number 056010
Leuven, 3000, Belgium
Investigational Site Number 076001
Curitiba, 80060-240, Brazil
Investigational Site Number 076006
Goiânia, 74110-120, Brazil
Investigational Site Number 076010
Juiz de Fora, 36010-570, Brazil
Investigational Site Number 076004
Porto Alegre, 90610-000, Brazil
Investigational Site Number 076005
Rio de Janeiro, 20551-030, Brazil
Investigational Site Number 076015
Rio de Janeiro, 22271-100, Brazil
Investigational Site Number 076011
Salvador, 40050-410, Brazil
Investigational Site Number 076002
São Paulo, 04039-901, Brazil
Investigational Site Number 076003
São Paulo, 04266-010, Brazil
Investigational Site Number 076013
Vitória, 29055 450, Brazil
Investigational Site Number 124003
Mississauga, L5M 2V8, Canada
Investigational Site Number 124002
St. Catharines, L2N 7E4, Canada
Investigational Site Number 124005
Toronto, M5T 2S8, Canada
Investigational Site Number 124009
Trois-Rivières, G8Z 1Y2, Canada
Investigational Site Number 124104
Victoria, V8V 3P9, Canada
Investigational Site Number 124012
Winnipeg, R3A 1M3, Canada
Investigational Site Number 152005
Osorno, 5311092, Chile
Investigational Site Number 152012
Santiago, 7500922, Chile
Investigational Site Number 152002
Santiago, 7501126, Chile
Investigational Site Number 152011
Santiago, 7510186, Chile
Investigational Site Number 152009
Santiago, 8207257, Chile
Investigational Site Number 152001
Santiago, 8360156, Chile
Investigational Site Number 152013
Santiago, 8360156, Chile
Investigational Site Number 152008
Santiago, Chile
Investigational Site Number 152014
Talca, Chile
Investigational Site Number 152015
Temuco IX Region, 4790928, Chile
Investigational Site Number 152004
Valdivia, 5090146, Chile
Investigational Site Number 152007
Viña del Mar, 2520997, Chile
Investigational Site Number 152006
Viña del Mar, Chile
Investigational Site Number 170005
Barranquilla, 080020399, Colombia
Investigational Site Number 170004
Barranquilla, 99999, Colombia
Investigational Site Number 170006
Bogotá, 11011, Colombia
Investigational Site Number 170001
Bogotá, 110221042, Colombia
Investigational Site Number 170003
Bogotá, 111211191, Colombia
Investigational Site Number 170008
Bogotá, 111211626, Colombia
Investigational Site Number 170007
Bucaramanga, 680003288, Colombia
Investigational Site Number 170009
Bucaramanga, 680003, Colombia
Investigational Site Number 203009
Liberec, 46063, Czechia
Investigational Site Number 203004
Ostrava, 702 00, Czechia
Investigational Site Number 203034
Pardubice, 53002, Czechia
Investigational Site Number 203001
Prague, 12850, Czechia
Investigational Site Number 203007
Prague, 12850, Czechia
Investigational Site Number 203011
Prague, 12850, Czechia
Investigational Site Number 203010
Prague, 140 00, Czechia
Investigational Site Number 203002
Uherské Hradiště, 686 01, Czechia
Investigational Site Number 203006
Zlín, 760 01, Czechia
Investigational Site Number 218003
Cuenca, 010204, Ecuador
Investigational Site Number 218001
Guayaquil, 090109, Ecuador
Investigational Site Number 218002
Quito, 170524, Ecuador
Investigational Site Number 233001
Tallinn, 10128, Estonia
Investigational Site Number 233010
Tallinn, 10138, Estonia
Investigational Site Number 233002
Tallinn, 13419, Estonia
Investigational Site Number 246001
Helsinki, 00290, Finland
Investigational Site Number 246002
Hyvinkää, 05800, Finland
Investigational Site Number 246003
Pori, 28100, Finland
Investigational Site Number 246010
Riihimäki, 11120, Finland
Investigational Site Number 276011
Bad Nauheim, 61231, Germany
Investigational Site Number 276010
Berlin, 10117, Germany
Investigational Site Number 276007
Berlin, 12161, Germany
Investigational Site Number 276008
Berlin, 12163, Germany
Investigational Site Number 276014
Berlin, 14059, Germany
Investigational Site Number 276018
Deggingen, 73326, Germany
Investigational Site Number 276015
Halle, 06108, Germany
Investigational Site Number 276005
Hamburg, 22081, Germany
Investigational Site Number 276013
Hamburg, 22147, Germany
Investigational Site Number 276001
Herne, 44649, Germany
Investigational Site Number 276016
Leipzig, 04103, Germany
Investigational Site Number 276017
München, 80336, Germany
Investigational Site Number 276021
Osnabrück, 49074, Germany
Investigational Site Number 276020
Tübingen, 72076, Germany
Investigational Site Number 276019
Zerbst, 39261, Germany
Investigational Site Number 300002
Heraklion, 71110, Greece
Investigational Site Number 300003
Thessaloniki, 54636, Greece
Investigational Site Number 300005
Thessaloniki, 57010, Greece
Investigational Site Number 320002
Guatemala City, 01009, Guatemala
Investigational Site Number 320003
Guatemala City, 01011, Guatemala
Investigational Site Number 320001
Guatemala City, 9090, Guatemala
Investigational Site Number 348006
Budapest, 1023, Hungary
Investigational Site Number 348014
Budapest, 1027, Hungary
Investigational Site Number 348025
Budapest, 1027, Hungary
Investigational Site Number 348022
Budapest, 1036, Hungary
Investigational Site Number 348010
Debrecen, 4031, Hungary
Investigational Site Number 348003
Debrecen, 4032, Hungary
Investigational Site Number 348021
Esztergom, 2500, Hungary
Investigational Site Number 348013
Győr, 9025, Hungary
Investigational Site Number 348005
Sátoraljaújhely, 3980, Hungary
Investigational Site Number 348004
Székesfehérvár, 8000, Hungary
Investigational Site Number 348009
Szolnok, 5000, Hungary
Investigational Site Number 348015
Szombathely, 9700, Hungary
Investigational Site Number 376001
Haifa, 31048, Israel
Investigational Site Number 376010
Haifa, 31096, Israel
Investigational Site Number 376011
Tel Aviv, 64239, Israel
Investigational Site Number 376002
Tel Litwinsky, 52621, Israel
Investigational Site Number 380005
Genova, 16132, Italy
Investigational Site Number 440001
Kaunas, 50009, Lithuania
Investigational Site Number 440006
Klaipėda, LT-92288, Lithuania
Investigational Site Number 440002
Vilnius, LT-08661, Lithuania
Investigational Site Number 440007
Vilnius, LT-08661, Lithuania
Investigational Site Number 458001
Ipoh, 30990, Malaysia
Investigational Site Number 458002
Kuching, 94300, Malaysia
Investigational Site Number 484023
Chihuahua City, 31000, Mexico
Investigational Site Number 484008
Durango, 34080, Mexico
Investigational Site Number 484018
Guadalajara, 44620, Mexico
Investigational Site Number 484002
Guadalajara, 44690, Mexico
Investigational Site Number 484035
León, 37000, Mexico
Investigational Site Number 484007
Metepec, 52140, Mexico
Investigational Site Number 484010
Mexicali, 21200, Mexico
Investigational Site Number 484003
Mexico City, 6726, Mexico
Investigational Site Number 484009
Mérida, 97000, Mexico
Investigational Site Number 484004
Mérida, 97070, Mexico
Investigational Site Number 484017
México, 06700, Mexico
Investigational Site Number 484001
México, D.F., 11850, Mexico
Investigational Site Number 484019
Monterrey, 64000, Mexico
Investigational Site Number 484020
Monterrey, 64000, Mexico
Investigational Site Number 484005
Monterrey, 64460, Mexico
Investigational Site Number 484021
Querétaro, 76000, Mexico
Investigational Site Number 528010
Amsterdam, 1056 AB, Netherlands
Investigational Site Number 554004
Christchurch, 8002, New Zealand
Investigational Site Number 554011
Nelson, 7010, New Zealand
Investigational Site Number 554007
Otahuhu, 2025, New Zealand
Investigational Site Number 554002
Rotorua, 3010, New Zealand
Investigational Site Number 554001
Timaru, 7910, New Zealand
Investigational Site Number 604001
Lima, 021, Peru
Investigational Site Number 604010
Lima, 14, Peru
Investigational Site Number 604008
Lima, 34, Peru
Investigational Site Number 604009
Lima, LIMA 01, Peru
Investigational Site Number 604006
Lima, LIMA 11, Peru
Investigational Site Number 604012
Lima, LIMA 11, Peru
Investigational Site Number 604013
Lima, LIMA 13, Peru
Investigational Site Number 604007
Lima, LIMA 33, Peru
Investigational Site Number 604005
Lima, LIMA 41, Peru
Investigational Site Number 608003
Cebu City, 6000, Philippines
Investigational Site Number 608001
Manila, 1008, Philippines
Investigational Site Number 616014
Bialystok, 15-099, Poland
Investigational Site Number 616002
Bialystok, 15-351, Poland
Investigational Site Number 616003
Bialystok, 15-879, Poland
Investigational Site Number 616019
Bydgoszcz, 85-168, Poland
Investigational Site Number 616054
Bytom, 41-902, Poland
Investigational Site Number 616015
Elblag, 82-300, Poland
Investigational Site Number 616001
Krakow, 30-510, Poland
Investigational Site Number 616005
Lublin, 20-582, Poland
Investigational Site Number 616030
Lublin, 20-954, Poland
Investigational Site Number 616018
Poznan, 61-397, Poland
Investigational Site Number 616016
Szczecin, 71-252, Poland
Investigational Site Number 616006
Torun, 87-100, Poland
Investigational Site Number 616031
Warsaw, 01-518, Poland
Investigational Site Number 616004
Warsaw, 02-118, Poland
Investigational Site Number 616017
Warsaw, 02-653, Poland
Investigational Site Number 616020
Wroclaw, 50-556, Poland
Investigational Site Number 616012
Wroclaw, 52-416, Poland
Investigational Site Number 620002
Lisbon, 1050-034, Portugal
Investigational Site Number 642006
Brăila, 810019, Romania
Investigational Site Number 642021
Bucharest, 010584, Romania
Investigational Site Number 642001
Bucharest, 010976, Romania
Investigational Site Number 642010
Bucharest, 011171, Romania
Investigational Site Number 642020
Bucharest, 020125, Romania
Investigational Site Number 642002
Bucharest, 020983, Romania
Investigational Site Number 642005
Galati, 800578, Romania
Investigational Site Number 643006
Kemerovo, 650000, Russia
Investigational Site Number 643017
Kemerovo, 650066, Russia
Investigational Site Number 643020
Moscow, 115404, Russia
Investigational Site Number 643001
Moscow, 115522, Russia
Investigational Site Number 643002
Moscow, 117997, Russia
Investigational Site Number 643021
Moscow, 119049, Russia
Investigational Site Number 643004
Moscow, 119333, Russia
Investigational Site Number 643012
Moscow, 121359, Russia
Investigational Site Number 643031
Moscow, 121374, Russia
Investigational Site Number 643030
Moscow, 125284, Russia
Investigational Site Number 643009
Novosibirsk, 630099, Russia
Investigational Site Number 643016
Ryazan, 390026, Russia
Investigational Site Number 643007
Saint Petersburg, 190068, Russia
Investigational Site Number 643032
Saint Petersburg, 191186, Russia
Investigational Site Number 643008
Saint Petersburg, 192242, Russia
Investigational Site Number 643014
Saint Petersburg, 196247, Russia
Investigational Site Number 643010
Samara, 443095, Russia
Investigational Site Number 643011
Saratov, 410053, Russia
Investigational Site Number 643013
Ufa, 450005, Russia
Investigational Site Number 710011
Cape Town, 7405, South Africa
Investigational Site Number 710007
Cape Town, 7500, South Africa
Investigational Site Number 710009
Cape Town, 8001, South Africa
Investigational Site Number 710003
Durban, 4001, South Africa
Investigational Site Number 710002
Durban, 4091, South Africa
Investigational Site Number 710001
Johannesburg, 2013, South Africa
Investigational Site Number 710004
Kempton Park, 1619, South Africa
Investigational Site Number 710005
Pretoria, 0002, South Africa
Investigational Site Number 710006
Pretoria, 0084, South Africa
Investigational Site Number 710010
Stellenbosch, 7600, South Africa
Investigational Site Number 410014
Anyang-si, 431-070, South Korea
Investigational Site Number 410006
Busan, 602-739, South Korea
Investigational Site Number 410004
Daegu, 700-721, South Korea
Investigational Site Number 410017
Daejeon, 301-721, South Korea
Investigational Site Number 410005
Daejeon, 302-799, South Korea
Investigational Site Number 410010
Gwangju, 61469, South Korea
Investigational Site Number 410001
Incheon, 21565, South Korea
Investigational Site Number 410009
Incheon, 400-711, South Korea
Investigational Site Number 410011
Jeonju, 561-712, South Korea
Investigational Site Number 410007
Seoul, 03080, South Korea
Investigational Site Number 410012
Seoul, 04763, South Korea
Investigational Site Number 410016
Seoul, 120-752, South Korea
Investigational Site Number 410003
Seoul, 150-713, South Korea
Investigational Site Number 410008
Suwon, 443-721, South Korea
Investigational Site Number 724009
A Coruña, 15006, Spain
Investigational Site Number 724016
Barakaldo, 48903, Spain
Investigational Site Number 724015
Barcelona, 08034, Spain
Investigational Site Number 724014
Cadiz, 11009, Spain
Investigational Site Number 724001
Málaga, 29010, Spain
Investigational Site Number 724011
Sabadell, 08208, Spain
Investigational Site Number 724012
Santiago de Compostela, 15705, Spain
Investigational Site Number 724013
Santiago de Compostela, 15706, Spain
Investigational Site Number 724022
Seville, 41010, Spain
Investigational Site Number 724007
Seville, 41071, Spain
Investigational Site Number 752002
Uppsala, 751 85, Sweden
Investigational Site Number 158006
Taichung, 40201, Taiwan
Investigational Site Number 158002
Taoyuan, 33305, Taiwan
Investigational Site Number 764001
Bangkok, 10400, Thailand
Investigational Site Number 764003
Bangkok, 10700, Thailand
Investigational Site Number 792008
Gaziantep, 27310, Turkey (Türkiye)
Investigational Site Number 804003
Dnipro, 49047, Ukraine
Investigational Site Number 804010
Kharkiv, 61058, Ukraine
Investigational Site Number 804013
Kharkiv, 61176, Ukraine
Investigational Site Number 804014
Kyiv, 01103, Ukraine
Investigational Site Number 804004
Kyiv, 03680, Ukraine
Investigational Site Number 804027
Kyiv, 03680, Ukraine
Investigational Site Number 804005
Lviv, 79010, Ukraine
Investigational Site Number 804006
Simferopol, 95017, Ukraine
Investigational Site Number 804011
Vinnytsia, 21018, Ukraine
Investigational Site Number 804009
Zaporizhzhya, 69600, Ukraine
Investigational Site Number 826004
Doncaster, DN2 5LT, United Kingdom
Investigational Site Number 826006
Edinburgh, EH4 2XU, United Kingdom
Investigational Site Number 826002
Leytonstone, E11 1NR, United Kingdom
Investigational Site Number 826005
Southampton, SO16 6YD, United Kingdom
Related Publications (5)
Burmester GR, Strand V, Kivitz AJ, Hu CC, Wang S, van Hoogstraten H, Klier GL, Fleischmann R. Long-term safety and efficacy of sarilumab with or without background csDMARDs in rheumatoid arthritis. Rheumatology (Oxford). 2023 Oct 3;62(10):3268-3279. doi: 10.1093/rheumatology/kead062.
PMID: 36727470DERIVEDChoy E, Bykerk V, Lee YC, van Hoogstraten H, Ford K, Praestgaard A, Perrot S, Pope J, Sebba A. Disproportionate articular pain is a frequent phenomenon in rheumatoid arthritis and responds to treatment with sarilumab. Rheumatology (Oxford). 2023 Jul 5;62(7):2386-2393. doi: 10.1093/rheumatology/keac659.
PMID: 36413080DERIVEDFleischmann 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.
PMID: 33871596DERIVEDEmery 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.
PMID: 33164349DERIVEDGenovese 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.
PMID: 31452928DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi aventis recherche & développement
Study Officials
- STUDY DIRECTOR
Clinical Sciences and Operations
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2010
First Posted
June 17, 2010
Study Start
June 21, 2010
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
March 28, 2022
Results First Posted
January 24, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
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