Clinical trial NCT01146652: Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
Official title: A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2010-06-17
Enrollment: 2023
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From first dose (i.e., Day 1 of study LTS11210) up to 60 days after last dose (maximum duration: up to 523 weeks)
measure: 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
timeFrame: From Week 24 to 36
measure: Sub-study: Number of Product Technical Complaints - Product Technical Failures With Pre-filled Syringe With Safety System
timeFrame: From Week 24 to 36
measure: Sub-study: Number of Failed Drug Deliveries Associated With Pre-filled Syringe With Safety System
timeFrame: From Week 24 to 36
measure: Sub-study: Number of Product Technical Complaints With Pre-filled Syringe With Safety System
timeFrame: From Week 24 to 36
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response
timeFrame: 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
measure: Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response
timeFrame: 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
measure: Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response
timeFrame: 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
measure: Percentage of Participants With Disease Activity Score for 28 Joints (DAS28) Remission
timeFrame: 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
measure: Percentage of Participants Achieving Good Response, Moderate Response or Non-response Using the European League Against Rheumatism (EULAR) Response Criteria
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: Baseline, Week 0 and 48 of LTS11210
measure: 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
timeFrame: Baseline, Week 48 and 96 of LTS11210
measure: 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
timeFrame: Baseline, Week 96, 144 and 192 of LTS11210
measure: 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
timeFrame: Week 0 (post-dose) and 48 of LTS11210
measure: 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
timeFrame: Week 48 and 96 of LTS11210
measure: 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
timeFrame: Week 96, 144 and 192 of LTS11210
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
measure: 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
timeFrame: Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
measure: 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
timeFrame: Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
measure: 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
timeFrame: Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
measure: 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
timeFrame: Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
measure: 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
timeFrame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
measure: 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
timeFrame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
measure: 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
timeFrame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
measure: 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
timeFrame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
measure: 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
timeFrame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
measure: 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
timeFrame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
measure: 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
timeFrame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
measure: 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
timeFrame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
measure: 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
timeFrame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
measure: 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
timeFrame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
measure: 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
timeFrame: Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
measure: Sub-study: Number of Participants Who Reported Adverse Events Related to Pre-filled Syringe With Safety System
timeFrame: From Week 24 to 36
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Investigational Site Number 840070
state: Alabama
city: Birmingham
country: United States
facility: Investigational Site Number 840138
state: Alabama
city: Huntsville
country: United States
facility: Investigational Site Number 840152
state: Alabama
city: Gilbert
country: United States
facility: Investigational Site Number 840072
state: Arizona
city: Glendale
country: United States
facility: Investigational Site Number 840141
state: Arizona
city: Fullerton
country: United States
facility: Investigational Site Number 840134
state: California
city: La Jolla
country: United States
facility: Investigational Site Number 840008
state: California
city: San Diego
country: United States
facility: Investigational Site Number 840135
state: California
city: Santa Maria
country: United States
facility: Investigational Site Number 840021
state: California
city: Stanford
country: United States
facility: Investigational Site Number 840100
state: California
city: Upland
country: United States
facility: Investigational Site Number 840049
state: California
city: Colorado Springs
country: United States
facility: Investigational Site Number 840151
state: Colorado
city: Lewes
country: United States
facility: Investigational Site Number 840130
state: Delaware
city: Aventura
country: United States
facility: Investigational Site Number 840153
state: Florida
city: Clearwater
country: United States
facility: Investigational Site Number 840050
state: Florida
city: Fort Lauderdale
country: United States
facility: Investigational Site Number 840033
state: Florida
city: Gainesville
country: United States
facility: Investigational Site Number 840041
state: Florida
city: Jupiter
country: United States
facility: Investigational Site Number 840067
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840048
state: Florida
city: Naples
country: United States
facility: Investigational Site Number 840024
state: Florida
city: Orlando
country: United States
facility: Investigational Site Number 840006
state: Florida
city: Ormond Beach
country: United States
facility: Investigational Site Number 840128
state: Florida
city: Palm Harbor
country: United States
facility: Investigational Site Number 840063
state: Florida
city: Palm Harbor
country: United States
facility: Investigational Site Number 840155
state: Florida
city: Sarasota
country: United States
facility: Investigational Site Number 840060
state: Florida
city: Tampa
country: United States
facility: Investigational Site Number 840140
state: Florida
city: Vero Beach
country: United States
facility: Investigational Site Number 840126
state: Florida
city: Atlanta
country: United States
facility: Investigational Site Number 840003
state: Georgia
city: Decatur
country: United States
facility: Investigational Site Number 840028
state: Georgia
city: Marietta
country: United States
facility: Investigational Site Number 840027
state: Georgia
city: Idaho Falls
country: United States
facility: Investigational Site Number 840018
state: Idaho
city: Chicago
country: United States
facility: Investigational Site Number 840046
state: Illinois
city: Kansas City
country: United States
facility: Investigational Site Number 840052
state: Kansas
city: Elizabethtown
country: United States
facility: Investigational Site Number 840230
state: Kentucky
city: Lexington
country: United States
facility: Investigational Site Number 840015
state: Kentucky
city: Baton Rouge
country: United States
facility: Investigational Site Number 840120
state: Louisiana
city: Lake Charles
country: United States
facility: Investigational Site Number 840109
state: Louisiana
city: Frederick
country: United States
facility: Investigational Site Number 840055
state: Maryland
city: Wheaton
country: United States
facility: Investigational Site Number 840013
state: Maryland
city: Boston
country: United States
facility: Investigational Site Number 840154
state: Massachusetts
city: Lansing
country: United States
facility: Investigational Site Number 840150
state: Michigan
city: Saint Clair Shores
country: United States
facility: Investigational Site Number 840137
state: Michigan
city: Lincoln
country: United States
facility: Investigational Site Number 840112
state: Nebraska
city: Freehold
country: United States
facility: Investigational Site Number 840026
state: New Jersey
city: Lake Success
country: United States
facility: Investigational Site Number 840115
state: New York
city: New York
country: United States
facility: Investigational Site Number 840056
state: New York
city: New York
country: United States
facility: Investigational Site Number 840043
state: New York
city: Orchard Park
country: United States
facility: Investigational Site Number 840106
state: New York
city: Smithtown
country: United States
facility: Investigational Site Number 840118
state: New York
city: Wilmington
country: United States
facility: Investigational Site Number 840116
state: North Carolina
city: Minot
country: United States
facility: Investigational Site Number 840233
state: North Dakota
city: Oklahoma City
country: United States
facility: Investigational Site Number 840002
state: Oklahoma
city: Oklahoma City
country: United States
facility: Investigational Site Number 840127
state: Oklahoma
city: Tulsa
country: United States
facility: Investigational Site Number 840011
state: Oklahoma
city: Tulsa
country: United States
facility: Investigational Site Number 840065
state: Oklahoma
city: Bethlehem
country: United States
facility: Investigational Site Number 840010
state: Pennsylvania
city: Duncansville
country: United States
facility: Investigational Site Number 840009
state: Pennsylvania
city: Reading
country: United States
facility: Investigational Site Number 840062
state: Pennsylvania
city: Columbia
country: United States
facility: Investigational Site Number 840058
state: South Carolina
city: North Charleston
country: United States
facility: Investigational Site Number 840016
state: South Carolina
city: Jackson
country: United States
facility: Investigational Site Number 840025
state: Tennessee
city: Memphis
country: United States
facility: Investigational Site Number 840059
state: Tennessee
city: Amarillo
country: United States
facility: Investigational Site Number 840032
state: Texas
city: Austin
country: United States
facility: Investigational Site Number 840038
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840001
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840022
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840012
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840129
state: Texas
city: Lubbock
country: United States
facility: Investigational Site Number 840069
state: Texas
city: Mesquite
country: United States
facility: Investigational Site Number 840074
state: Texas
city: Nassau Bay
country: United States
facility: Investigational Site Number 840020
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840103
state: Texas
city: Spokane
country: United States
facility: Investigational Site Number 840036
state: Washington
city: Tacoma
country: United States
facility: Investigational Site Number 840061
state: Washington
city: Clarksburg
country: United States
facility: Investigational Site Number 840124
state: West Virginia
city: Caba
country: Argentina
facility: Investigational Site Number 032006
city: Caba
country: Argentina
facility: Investigational Site Number 032007
city: Caba
country: Argentina
facility: Investigational Site Number 032008
city: Capital Federal
country: Argentina
facility: Investigational Site Number 032019
city: Capital Federal
country: Argentina
facility: Investigational Site Number 032016
city: Cordoba
country: Argentina
facility: Investigational Site Number 032002
city: Cordoba
country: Argentina
facility: Investigational Site Number 032020
city: Córdoba
country: Argentina
facility: Investigational Site Number 032003
city: La Plata
country: Argentina
facility: Investigational Site Number 032017
city: Mar Del Plata
country: Argentina
facility: Investigational Site Number 032012
city: Quilmes
country: Argentina
facility: Investigational Site Number 032011
city: Ramos Mejia
country: Argentina
facility: Investigational Site Number 032010
city: Rosario
country: Argentina
facility: Investigational Site Number 032001
city: Rosario
country: Argentina
facility: Investigational Site Number 032013
city: San Fernando
country: Argentina
facility: Investigational Site Number 032015
city: San Miguel De Tucuman
country: Argentina
facility: Investigational Site Number 032005
city: San Miguel De Tucuman
country: Argentina
facility: Investigational Site Number 032004
city: Zarate
country: Argentina
facility: Investigational Site Number 032009
city: Camperdown
country: Australia
facility: Investigational Site Number 036003
city: Fitzroy
country: Australia
facility: Investigational Site Number 036012
city: Garran
country: Australia
facility: Investigational Site Number 036010
city: Heidelberg West
country: Australia
facility: Investigational Site Number 036004
city: Maroochydore
country: Australia
facility: Investigational Site Number 036001
city: Victoria Park
country: Australia
facility: Investigational Site Number 036014
city: Woodville
country: Australia
facility: Investigational Site Number 036007
city: Graz
country: Austria
facility: Investigational Site Number 040001
city: Minsk
country: Belarus
facility: Investigational Site Number 112002
city: Minsk
country: Belarus
facility: Investigational Site Number 112001
city: Leuven
country: Belgium
facility: Investigational Site Number 056010
city: Curitiba
country: Brazil
facility: Investigational Site Number 076001
city: Goiania
country: Brazil
facility: Investigational Site Number 076006
city: Juiz De Fora
country: Brazil
facility: Investigational Site Number 076010
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076004
city: Rio De Janeiro
country: Brazil
facility: Investigational Site Number 076005
city: Rio De Janeiro
country: Brazil
facility: Investigational Site Number 076015
city: Salvador
country: Brazil
facility: Investigational Site Number 076011
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076002
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076003
city: Vitoria
country: Brazil
facility: Investigational Site Number 076013
city: Mississauga
country: Canada
facility: Investigational Site Number 124003
city: St. Catharines
country: Canada
facility: Investigational Site Number 124002
city: Toronto
country: Canada
facility: Investigational Site Number 124005
city: Trois-Rivières
country: Canada
facility: Investigational Site Number 124009
city: Victoria
country: Canada
facility: Investigational Site Number 124104
city: Winnipeg
country: Canada
facility: Investigational Site Number 124012
city: Osorno
country: Chile
facility: Investigational Site Number 152005
city: Santiago
country: Chile
facility: Investigational Site Number 152012
city: Santiago
country: Chile
facility: Investigational Site Number 152002
city: Santiago
country: Chile
facility: Investigational Site Number 152011
city: Santiago
country: Chile
facility: Investigational Site Number 152009
city: Santiago
country: Chile
facility: Investigational Site Number 152001
city: Santiago
country: Chile
facility: Investigational Site Number 152013
city: Santiago
country: Chile
facility: Investigational Site Number 152008
city: Talca
country: Chile
facility: Investigational Site Number 152014
city: Temuco IX Region
country: Chile
facility: Investigational Site Number 152015
city: Valdivia
country: Chile
facility: Investigational Site Number 152004
city: Vina Del Mar
country: Chile
facility: Investigational Site Number 152006
city: Viña Del Mar
country: Chile
facility: Investigational Site Number 152007
city: Barranquilla
country: Colombia
facility: Investigational Site Number 170005
city: Barranquilla
country: Colombia
facility: Investigational Site Number 170004
city: Bogota
country: Colombia
facility: Investigational Site Number 170001
city: Bogota
country: Colombia
facility: Investigational Site Number 170008
city: Bogotá
country: Colombia
facility: Investigational Site Number 170006
city: Bogotá
country: Colombia
facility: Investigational Site Number 170003
city: Bucaramanga
country: Colombia
facility: Investigational Site Number 170007
city: Bucaramanga
country: Colombia
facility: Investigational Site Number 170009
city: Liberec
country: Czechia
facility: Investigational Site Number 203009
city: Ostrava
country: Czechia
facility: Investigational Site Number 203004
city: Pardubice
country: Czechia
facility: Investigational Site Number 203034
city: Praha 2
country: Czechia
facility: Investigational Site Number 203001
city: Praha 2
country: Czechia
facility: Investigational Site Number 203007
city: Praha 2
country: Czechia
facility: Investigational Site Number 203011
city: Praha 4
country: Czechia
facility: Investigational Site Number 203010
city: Uherske Hradiste
country: Czechia
facility: Investigational Site Number 203002
city: Zlin
country: Czechia
facility: Investigational Site Number 203006
city: Cuenca
country: Ecuador
facility: Investigational Site Number 218003
city: Guayaquil
country: Ecuador
facility: Investigational Site Number 218001
city: Quito
country: Ecuador
facility: Investigational Site Number 218002
city: Tallinn
country: Estonia
facility: Investigational Site Number 233001
city: Tallinn
country: Estonia
facility: Investigational Site Number 233010
city: Tallinn
country: Estonia
facility: Investigational Site Number 233002
city: Helsinki
country: Finland
facility: Investigational Site Number 246001
city: Hyvinkää
country: Finland
facility: Investigational Site Number 246002
city: Pori
country: Finland
facility: Investigational Site Number 246003
city: Riihimäki
country: Finland
facility: Investigational Site Number 246010
city: Bad Nauheim
country: Germany
facility: Investigational Site Number 276011
city: Berlin
country: Germany
facility: Investigational Site Number 276010
city: Berlin
country: Germany
facility: Investigational Site Number 276007
city: Berlin
country: Germany
facility: Investigational Site Number 276008
city: Berlin
country: Germany
facility: Investigational Site Number 276014
city: Deggingen
country: Germany
facility: Investigational Site Number 276018
city: Halle/Saale
country: Germany
facility: Investigational Site Number 276015
city: Hamburg
country: Germany
facility: Investigational Site Number 276005
city: Hamburg
country: Germany
facility: Investigational Site Number 276013
city: Herne
country: Germany
facility: Investigational Site Number 276001
city: Leipzig
country: Germany
facility: Investigational Site Number 276016
city: München
country: Germany
facility: Investigational Site Number 276017
city: Osnabrück
country: Germany
facility: Investigational Site Number 276021
city: Tübingen
country: Germany
facility: Investigational Site Number 276020
city: Zerbst
country: Germany
facility: Investigational Site Number 276019
city: Heraklion
country: Greece
facility: Investigational Site Number 300002
city: Thessaloniki
country: Greece
facility: Investigational Site Number 300003
city: Thessaloniki
country: Greece
facility: Investigational Site Number 300005
city: Guatemala City
country: Guatemala
facility: Investigational Site Number 320002
city: Guatemala City
country: Guatemala
facility: Investigational Site Number 320003
city: Guatemala
country: Guatemala
facility: Investigational Site Number 320001
city: Budapest
country: Hungary
facility: Investigational Site Number 348006
city: Budapest
country: Hungary
facility: Investigational Site Number 348014
city: Budapest
country: Hungary
facility: Investigational Site Number 348025
city: Budapest
country: Hungary
facility: Investigational Site Number 348022
city: Debrecen
country: Hungary
facility: Investigational Site Number 348010
city: Debrecen
country: Hungary
facility: Investigational Site Number 348003
city: Esztergom
country: Hungary
facility: Investigational Site Number 348021
city: Györ
country: Hungary
facility: Investigational Site Number 348013
city: Szolnok
country: Hungary
facility: Investigational Site Number 348009
city: Szombathely
country: Hungary
facility: Investigational Site Number 348015
city: Székesfehérvár
country: Hungary
facility: Investigational Site Number 348004
city: Sátoraljaújhely
country: Hungary
facility: Investigational Site Number 348005
city: Haifa
country: Israel
facility: Investigational Site Number 376001
city: Haifa
country: Israel
facility: Investigational Site Number 376010
city: Tel Aviv
country: Israel
facility: Investigational Site Number 376011
city: Tel Hashomer
country: Israel
facility: Investigational Site Number 376002
city: Genova
country: Italy
facility: Investigational Site Number 380005
city: Anyang-Si
country: Korea, Republic of
facility: Investigational Site Number 410014
city: Busan
country: Korea, Republic of
facility: Investigational Site Number 410006
city: Daegu
country: Korea, Republic of
facility: Investigational Site Number 410004
city: Daejeon
country: Korea, Republic of
facility: Investigational Site Number 410017
city: Daejeon
country: Korea, Republic of
facility: Investigational Site Number 410005
city: Gwangju
country: Korea, Republic of
facility: Investigational Site Number 410010
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number 410001
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number 410009
city: Jeonju
country: Korea, Republic of
facility: Investigational Site Number 410011
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410007
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410012
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410016
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410003
city: Suwon
country: Korea, Republic of
facility: Investigational Site Number 410008
city: Kaunas
country: Lithuania
facility: Investigational Site Number 440001
city: Klaipeda
country: Lithuania
facility: Investigational Site Number 440006
city: Vilnius
country: Lithuania
facility: Investigational Site Number 440002
city: Vilnius
country: Lithuania
facility: Investigational Site Number 440007
city: Ipoh
country: Malaysia
facility: Investigational Site Number 458001
city: Kuching
country: Malaysia
facility: Investigational Site Number 458002
city: Chihuahua
country: Mexico
facility: Investigational Site Number 484023
city: Durango
country: Mexico
facility: Investigational Site Number 484008
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484018
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484002
city: Leon
country: Mexico
facility: Investigational Site Number 484035
city: Merida
country: Mexico
facility: Investigational Site Number 484009
city: Metepec
country: Mexico
facility: Investigational Site Number 484007
city: Mexicali
country: Mexico
facility: Investigational Site Number 484010
city: Mexico City
country: Mexico
facility: Investigational Site Number 484003
city: Monterrey
country: Mexico
facility: Investigational Site Number 484019
city: Monterrey
country: Mexico
facility: Investigational Site Number 484020
city: Monterrey
country: Mexico
facility: Investigational Site Number 484005
city: Mérida
country: Mexico
facility: Investigational Site Number 484004
city: México, D.F.
country: Mexico
facility: Investigational Site Number 484001
city: México
country: Mexico
facility: Investigational Site Number 484017
city: Queretaro
country: Mexico
facility: Investigational Site Number 484021
city: Amsterdam
country: Netherlands
facility: Investigational Site Number 528010
city: Christchurch
country: New Zealand
facility: Investigational Site Number 554004
city: Nelson
country: New Zealand
facility: Investigational Site Number 554011
city: Otahuhu
country: New Zealand
facility: Investigational Site Number 554007
city: Rotorua
country: New Zealand
facility: Investigational Site Number 554002
city: Timaru
country: New Zealand
facility: Investigational Site Number 554001
city: Lima
country: Peru
facility: Investigational Site Number 604001
city: Lima
country: Peru
facility: Investigational Site Number 604010
city: Lima
country: Peru
facility: Investigational Site Number 604008
city: Lima
country: Peru
facility: Investigational Site Number 604009
city: Lima
country: Peru
facility: Investigational Site Number 604006
city: Lima
country: Peru
facility: Investigational Site Number 604012
city: Lima
country: Peru
facility: Investigational Site Number 604013
city: Lima
country: Peru
facility: Investigational Site Number 604007
city: Lima
country: Peru
facility: Investigational Site Number 604005
city: Cebu City
country: Philippines
facility: Investigational Site Number 608003
city: Manila
country: Philippines
facility: Investigational Site Number 608001
city: Bialystok
country: Poland
facility: Investigational Site Number 616014
city: Bialystok
country: Poland
facility: Investigational Site Number 616002
city: Bialystok
country: Poland
facility: Investigational Site Number 616003
city: Bydgoszcz
country: Poland
facility: Investigational Site Number 616019
city: Bytom
country: Poland
facility: Investigational Site Number 616054
city: Elblag
country: Poland
facility: Investigational Site Number 616015
city: Krakow
country: Poland
facility: Investigational Site Number 616001
city: Lublin
country: Poland
facility: Investigational Site Number 616005
city: Lublin
country: Poland
facility: Investigational Site Number 616030
city: Poznan
country: Poland
facility: Investigational Site Number 616018
city: Szczecin
country: Poland
facility: Investigational Site Number 616016
city: Torun
country: Poland
facility: Investigational Site Number 616006
city: Warszawa
country: Poland
facility: Investigational Site Number 616031
city: Warszawa
country: Poland
facility: Investigational Site Number 616004
city: Warszawa
country: Poland
facility: Investigational Site Number 616017
city: Wroclaw
country: Poland
facility: Investigational Site Number 616020
city: Wroclaw
country: Poland
facility: Investigational Site Number 616012
city: Lisboa
country: Portugal
facility: Investigational Site Number 620002
city: Braila
country: Romania
facility: Investigational Site Number 642006
city: Bucharest
country: Romania
facility: Investigational Site Number 642010
city: Bucuresti
country: Romania
facility: Investigational Site Number 642021
city: Bucuresti
country: Romania
facility: Investigational Site Number 642001
city: Bucuresti
country: Romania
facility: Investigational Site Number 642020
city: Bucuresti
country: Romania
facility: Investigational Site Number 642002
city: Galati
country: Romania
facility: Investigational Site Number 642005
city: Kemerovo
country: Russian Federation
facility: Investigational Site Number 643006
city: Kemerovo
country: Russian Federation
facility: Investigational Site Number 643017
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643020
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643001
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643002
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643021
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643004
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643012
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643031
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643030
city: Novosibirsk
country: Russian Federation
facility: Investigational Site Number 643009
city: Ryazan
country: Russian Federation
facility: Investigational Site Number 643016
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 643008
city: Samara
country: Russian Federation
facility: Investigational Site Number 643010
city: Saratov
country: Russian Federation
facility: Investigational Site Number 643011
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643007
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643032
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643014
city: Ufa
country: Russian Federation
facility: Investigational Site Number 643013
city: Cape Town
country: South Africa
facility: Investigational Site Number 710011
city: Cape Town
country: South Africa
facility: Investigational Site Number 710007
city: Cape Town
country: South Africa
facility: Investigational Site Number 710009
city: Durban
country: South Africa
facility: Investigational Site Number 710003
city: Durban
country: South Africa
facility: Investigational Site Number 710002
city: Johannesburg
country: South Africa
facility: Investigational Site Number 710001
city: Kempton Park
country: South Africa
facility: Investigational Site Number 710004
city: Pretoria
country: South Africa
facility: Investigational Site Number 710005
city: Pretoria
country: South Africa
facility: Investigational Site Number 710006
city: Stellenbosch
country: South Africa
facility: Investigational Site Number 710010
city: Barakaldo
country: Spain
facility: Investigational Site Number 724016
city: Barcelona
country: Spain
facility: Investigational Site Number 724015
city: Cádiz
country: Spain
facility: Investigational Site Number 724014
city: La Coruña
country: Spain
facility: Investigational Site Number 724009
city: Málaga
country: Spain
facility: Investigational Site Number 724001
city: Sabadell
country: Spain
facility: Investigational Site Number 724011
city: Santiago De Compostela
country: Spain
facility: Investigational Site Number 724012
city: Santiago De Compostela
country: Spain
facility: Investigational Site Number 724013
city: Sevilla
country: Spain
facility: Investigational Site Number 724022
city: Sevilla
country: Spain
facility: Investigational Site Number 724007
city: Uppsala
country: Sweden
facility: Investigational Site Number 752002
city: Taichung
country: Taiwan
facility: Investigational Site Number 158006
city: Taoyuan County
country: Taiwan
facility: Investigational Site Number 158002
city: Bangkok
country: Thailand
facility: Investigational Site Number 764001
city: Bangkok
country: Thailand
facility: Investigational Site Number 764003
city: Gaziantep
country: Turkey
facility: Investigational Site Number 792008
city: Dnipro
country: Ukraine
facility: Investigational Site Number 804003
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 804010
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 804013
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804014
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804004
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804027
city: Lviv
country: Ukraine
facility: Investigational Site Number 804005
city: Simferopol
country: Ukraine
facility: Investigational Site Number 804006
city: Vinnytsya
country: Ukraine
facility: Investigational Site Number 804011
city: Zaporizhzhya
country: Ukraine
facility: Investigational Site Number 804009
city: Doncaster
country: United Kingdom
facility: Investigational Site Number 826004
city: Edinburgh
country: United Kingdom
facility: Investigational Site Number 826006
city: Leytonstone
country: United Kingdom
facility: Investigational Site Number 826002
city: Southampton
country: United Kingdom
facility: Investigational Site Number 826005
Study officials:
affiliation: Sanofi
name: Clinical Sciences and Operations
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.