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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01146652




Registration number
NCT01146652
Ethics application status
Date submitted
15/06/2010
Date registered
17/06/2010

Titles & IDs
Public title
Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
Scientific title
A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)
Secondary ID [1] 0 0
2010-019262-86
Secondary ID [2] 0 0
LTS11210
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SAR153191 (REGN88)

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.

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).


Treatment: Drugs: SAR153191 (REGN88)
Pharmaceutical form: solution

Route of administration: subcutaneous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
From first dose (i.e., Day 1 of study LTS11210) up to 60 days after last dose (maximum duration: up to 523 weeks)
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
From Week 24 to 36
Primary outcome [3] 0 0
Sub-study: Number of Product Technical Complaints - Product Technical Failures With Pre-filled Syringe With Safety System
Timepoint [3] 0 0
From Week 24 to 36
Primary outcome [4] 0 0
Sub-study: Number of Failed Drug Deliveries Associated With Pre-filled Syringe With Safety System
Timepoint [4] 0 0
From Week 24 to 36
Primary outcome [5] 0 0
Sub-study: Number of Product Technical Complaints With Pre-filled Syringe With Safety System
Timepoint [5] 0 0
From Week 24 to 36
Secondary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Percentage of Participants With Disease Activity Score for 28 Joints (DAS28) Remission
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Percentage of Participants Achieving Good Response, Moderate Response or Non-response Using the European League Against Rheumatism (EULAR) Response Criteria
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Baseline, Week 0 and 48 of LTS11210
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Baseline, Week 48 and 96 of LTS11210
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Baseline, Week 96, 144 and 192 of LTS11210
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Week 0 (post-dose) and 48 of LTS11210
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
Week 48 and 96 of LTS11210
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Week 96, 144 and 192 of LTS11210
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
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
Secondary outcome [15] 0 0
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
Timepoint [15] 0 0
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
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
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
Secondary outcome [17] 0 0
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
Timepoint [17] 0 0
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
Secondary outcome [18] 0 0
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
Timepoint [18] 0 0
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
Secondary outcome [19] 0 0
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
Timepoint [19] 0 0
Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Secondary outcome [20] 0 0
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
Timepoint [20] 0 0
Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Secondary outcome [21] 0 0
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
Timepoint [21] 0 0
Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Secondary outcome [22] 0 0
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
Timepoint [22] 0 0
Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Secondary outcome [23] 0 0
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
Timepoint [23] 0 0
Baseline, Week 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Secondary outcome [24] 0 0
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
Timepoint [24] 0 0
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Secondary outcome [25] 0 0
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
Timepoint [25] 0 0
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Secondary outcome [26] 0 0
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
Timepoint [26] 0 0
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Secondary outcome [27] 0 0
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
Timepoint [27] 0 0
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Secondary outcome [28] 0 0
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
Timepoint [28] 0 0
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Secondary outcome [29] 0 0
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
Timepoint [29] 0 0
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Secondary outcome [30] 0 0
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
Timepoint [30] 0 0
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Secondary outcome [31] 0 0
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
Timepoint [31] 0 0
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Secondary outcome [32] 0 0
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
Timepoint [32] 0 0
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Secondary outcome [33] 0 0
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
Timepoint [33] 0 0
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Secondary outcome [34] 0 0
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
Timepoint [34] 0 0
Baseline, Weeks 0 (post-dose), 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210
Secondary outcome [35] 0 0
Sub-study: Number of Participants Who Reported Adverse Events Related to Pre-filled Syringe With Safety System
Timepoint [35] 0 0
From Week 24 to 36

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2020
Sample size
Target
Accrual to date
Final
2023
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036003 - Camperdown
Recruitment hospital [2] 0 0
Investigational Site Number 036012 - Fitzroy
Recruitment hospital [3] 0 0
Investigational Site Number 036010 - Garran
Recruitment hospital [4] 0 0
Investigational Site Number 036004 - Heidelberg West
Recruitment hospital [5] 0 0
Investigational Site Number 036001 - Maroochydore
Recruitment hospital [6] 0 0
Investigational Site Number 036014 - Victoria Park
Recruitment hospital [7] 0 0
Investigational Site Number 036007 - Woodville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
2605 - Garran
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [5] 0 0
4558 - Maroochydore
Recruitment postcode(s) [6] 0 0
6100 - Victoria Park
Recruitment postcode(s) [7] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
North Dakota
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
United States of America
State/province [27] 0 0
West Virginia
Country [28] 0 0
Argentina
State/province [28] 0 0
Caba
Country [29] 0 0
Argentina
State/province [29] 0 0
Capital Federal
Country [30] 0 0
Argentina
State/province [30] 0 0
Cordoba
Country [31] 0 0
Argentina
State/province [31] 0 0
Córdoba
Country [32] 0 0
Argentina
State/province [32] 0 0
La Plata
Country [33] 0 0
Argentina
State/province [33] 0 0
Mar Del Plata
Country [34] 0 0
Argentina
State/province [34] 0 0
Quilmes
Country [35] 0 0
Argentina
State/province [35] 0 0
Ramos Mejia
Country [36] 0 0
Argentina
State/province [36] 0 0
Rosario
Country [37] 0 0
Argentina
State/province [37] 0 0
San Fernando
Country [38] 0 0
Argentina
State/province [38] 0 0
San Miguel De Tucuman
Country [39] 0 0
Argentina
State/province [39] 0 0
Zarate
Country [40] 0 0
Austria
State/province [40] 0 0
Graz
Country [41] 0 0
Belarus
State/province [41] 0 0
Minsk
Country [42] 0 0
Belgium
State/province [42] 0 0
Leuven
Country [43] 0 0
Brazil
State/province [43] 0 0
Curitiba
Country [44] 0 0
Brazil
State/province [44] 0 0
Goiania
Country [45] 0 0
Brazil
State/province [45] 0 0
Juiz De Fora
Country [46] 0 0
Brazil
State/province [46] 0 0
Porto Alegre
Country [47] 0 0
Brazil
State/province [47] 0 0
Rio De Janeiro
Country [48] 0 0
Brazil
State/province [48] 0 0
Salvador
Country [49] 0 0
Brazil
State/province [49] 0 0
Sao Paulo
Country [50] 0 0
Brazil
State/province [50] 0 0
Vitoria
Country [51] 0 0
Canada
State/province [51] 0 0
Mississauga
Country [52] 0 0
Canada
State/province [52] 0 0
St. Catharines
Country [53] 0 0
Canada
State/province [53] 0 0
Toronto
Country [54] 0 0
Canada
State/province [54] 0 0
Trois-Rivières
Country [55] 0 0
Canada
State/province [55] 0 0
Victoria
Country [56] 0 0
Canada
State/province [56] 0 0
Winnipeg
Country [57] 0 0
Chile
State/province [57] 0 0
Osorno
Country [58] 0 0
Chile
State/province [58] 0 0
Santiago
Country [59] 0 0
Chile
State/province [59] 0 0
Talca
Country [60] 0 0
Chile
State/province [60] 0 0
Temuco IX Region
Country [61] 0 0
Chile
State/province [61] 0 0
Valdivia
Country [62] 0 0
Chile
State/province [62] 0 0
Vina Del Mar
Country [63] 0 0
Chile
State/province [63] 0 0
Viña Del Mar
Country [64] 0 0
Colombia
State/province [64] 0 0
Barranquilla
Country [65] 0 0
Colombia
State/province [65] 0 0
Bogota
Country [66] 0 0
Colombia
State/province [66] 0 0
Bogotá
Country [67] 0 0
Colombia
State/province [67] 0 0
Bucaramanga
Country [68] 0 0
Czechia
State/province [68] 0 0
Liberec
Country [69] 0 0
Czechia
State/province [69] 0 0
Ostrava
Country [70] 0 0
Czechia
State/province [70] 0 0
Pardubice
Country [71] 0 0
Czechia
State/province [71] 0 0
Praha 2
Country [72] 0 0
Czechia
State/province [72] 0 0
Praha 4
Country [73] 0 0
Czechia
State/province [73] 0 0
Uherske Hradiste
Country [74] 0 0
Czechia
State/province [74] 0 0
Zlin
Country [75] 0 0
Ecuador
State/province [75] 0 0
Cuenca
Country [76] 0 0
Ecuador
State/province [76] 0 0
Guayaquil
Country [77] 0 0
Ecuador
State/province [77] 0 0
Quito
Country [78] 0 0
Estonia
State/province [78] 0 0
Tallinn
Country [79] 0 0
Finland
State/province [79] 0 0
Helsinki
Country [80] 0 0
Finland
State/province [80] 0 0
Hyvinkää
Country [81] 0 0
Finland
State/province [81] 0 0
Pori
Country [82] 0 0
Finland
State/province [82] 0 0
Riihimäki
Country [83] 0 0
Germany
State/province [83] 0 0
Bad Nauheim
Country [84] 0 0
Germany
State/province [84] 0 0
Berlin
Country [85] 0 0
Germany
State/province [85] 0 0
Deggingen
Country [86] 0 0
Germany
State/province [86] 0 0
Halle/Saale
Country [87] 0 0
Germany
State/province [87] 0 0
Hamburg
Country [88] 0 0
Germany
State/province [88] 0 0
Herne
Country [89] 0 0
Germany
State/province [89] 0 0
Leipzig
Country [90] 0 0
Germany
State/province [90] 0 0
München
Country [91] 0 0
Germany
State/province [91] 0 0
Osnabrück
Country [92] 0 0
Germany
State/province [92] 0 0
Tübingen
Country [93] 0 0
Germany
State/province [93] 0 0
Zerbst
Country [94] 0 0
Greece
State/province [94] 0 0
Heraklion
Country [95] 0 0
Greece
State/province [95] 0 0
Thessaloniki
Country [96] 0 0
Guatemala
State/province [96] 0 0
Guatemala City
Country [97] 0 0
Guatemala
State/province [97] 0 0
Guatemala
Country [98] 0 0
Hungary
State/province [98] 0 0
Budapest
Country [99] 0 0
Hungary
State/province [99] 0 0
Debrecen
Country [100] 0 0
Hungary
State/province [100] 0 0
Esztergom
Country [101] 0 0
Hungary
State/province [101] 0 0
Györ
Country [102] 0 0
Hungary
State/province [102] 0 0
Szolnok
Country [103] 0 0
Hungary
State/province [103] 0 0
Szombathely
Country [104] 0 0
Hungary
State/province [104] 0 0
Székesfehérvár
Country [105] 0 0
Hungary
State/province [105] 0 0
Sátoraljaújhely
Country [106] 0 0
Israel
State/province [106] 0 0
Haifa
Country [107] 0 0
Israel
State/province [107] 0 0
Tel Aviv
Country [108] 0 0
Israel
State/province [108] 0 0
Tel Hashomer
Country [109] 0 0
Italy
State/province [109] 0 0
Genova
Country [110] 0 0
Korea, Republic of
State/province [110] 0 0
Anyang-Si
Country [111] 0 0
Korea, Republic of
State/province [111] 0 0
Busan
Country [112] 0 0
Korea, Republic of
State/province [112] 0 0
Daegu
Country [113] 0 0
Korea, Republic of
State/province [113] 0 0
Daejeon
Country [114] 0 0
Korea, Republic of
State/province [114] 0 0
Gwangju
Country [115] 0 0
Korea, Republic of
State/province [115] 0 0
Incheon
Country [116] 0 0
Korea, Republic of
State/province [116] 0 0
Jeonju
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Korea, Republic of
State/province [117] 0 0
Seoul
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Korea, Republic of
State/province [118] 0 0
Suwon
Country [119] 0 0
Lithuania
State/province [119] 0 0
Kaunas
Country [120] 0 0
Lithuania
State/province [120] 0 0
Klaipeda
Country [121] 0 0
Lithuania
State/province [121] 0 0
Vilnius
Country [122] 0 0
Malaysia
State/province [122] 0 0
Ipoh
Country [123] 0 0
Malaysia
State/province [123] 0 0
Kuching
Country [124] 0 0
Mexico
State/province [124] 0 0
Chihuahua
Country [125] 0 0
Mexico
State/province [125] 0 0
Durango
Country [126] 0 0
Mexico
State/province [126] 0 0
Guadalajara
Country [127] 0 0
Mexico
State/province [127] 0 0
Leon
Country [128] 0 0
Mexico
State/province [128] 0 0
Merida
Country [129] 0 0
Mexico
State/province [129] 0 0
Metepec
Country [130] 0 0
Mexico
State/province [130] 0 0
Mexicali
Country [131] 0 0
Mexico
State/province [131] 0 0
Mexico City
Country [132] 0 0
Mexico
State/province [132] 0 0
Monterrey
Country [133] 0 0
Mexico
State/province [133] 0 0
Mérida
Country [134] 0 0
Mexico
State/province [134] 0 0
México, D.F.
Country [135] 0 0
Mexico
State/province [135] 0 0
México
Country [136] 0 0
Mexico
State/province [136] 0 0
Queretaro
Country [137] 0 0
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State/province [137] 0 0
Amsterdam
Country [138] 0 0
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State/province [138] 0 0
Christchurch
Country [139] 0 0
New Zealand
State/province [139] 0 0
Nelson
Country [140] 0 0
New Zealand
State/province [140] 0 0
Otahuhu
Country [141] 0 0
New Zealand
State/province [141] 0 0
Rotorua
Country [142] 0 0
New Zealand
State/province [142] 0 0
Timaru
Country [143] 0 0
Peru
State/province [143] 0 0
Lima
Country [144] 0 0
Philippines
State/province [144] 0 0
Cebu City
Country [145] 0 0
Philippines
State/province [145] 0 0
Manila
Country [146] 0 0
Poland
State/province [146] 0 0
Bialystok
Country [147] 0 0
Poland
State/province [147] 0 0
Bydgoszcz
Country [148] 0 0
Poland
State/province [148] 0 0
Bytom
Country [149] 0 0
Poland
State/province [149] 0 0
Elblag
Country [150] 0 0
Poland
State/province [150] 0 0
Krakow
Country [151] 0 0
Poland
State/province [151] 0 0
Lublin
Country [152] 0 0
Poland
State/province [152] 0 0
Poznan
Country [153] 0 0
Poland
State/province [153] 0 0
Szczecin
Country [154] 0 0
Poland
State/province [154] 0 0
Torun
Country [155] 0 0
Poland
State/province [155] 0 0
Warszawa
Country [156] 0 0
Poland
State/province [156] 0 0
Wroclaw
Country [157] 0 0
Portugal
State/province [157] 0 0
Lisboa
Country [158] 0 0
Romania
State/province [158] 0 0
Braila
Country [159] 0 0
Romania
State/province [159] 0 0
Bucharest
Country [160] 0 0
Romania
State/province [160] 0 0
Bucuresti
Country [161] 0 0
Romania
State/province [161] 0 0
Galati
Country [162] 0 0
Russian Federation
State/province [162] 0 0
Kemerovo
Country [163] 0 0
Russian Federation
State/province [163] 0 0
Moscow
Country [164] 0 0
Russian Federation
State/province [164] 0 0
Novosibirsk
Country [165] 0 0
Russian Federation
State/province [165] 0 0
Ryazan
Country [166] 0 0
Russian Federation
State/province [166] 0 0
Saint-Petersburg
Country [167] 0 0
Russian Federation
State/province [167] 0 0
Samara
Country [168] 0 0
Russian Federation
State/province [168] 0 0
Saratov
Country [169] 0 0
Russian Federation
State/province [169] 0 0
St-Petersburg
Country [170] 0 0
Russian Federation
State/province [170] 0 0
Ufa
Country [171] 0 0
South Africa
State/province [171] 0 0
Cape Town
Country [172] 0 0
South Africa
State/province [172] 0 0
Durban
Country [173] 0 0
South Africa
State/province [173] 0 0
Johannesburg
Country [174] 0 0
South Africa
State/province [174] 0 0
Kempton Park
Country [175] 0 0
South Africa
State/province [175] 0 0
Pretoria
Country [176] 0 0
South Africa
State/province [176] 0 0
Stellenbosch
Country [177] 0 0
Spain
State/province [177] 0 0
Barakaldo
Country [178] 0 0
Spain
State/province [178] 0 0
Barcelona
Country [179] 0 0
Spain
State/province [179] 0 0
Cádiz
Country [180] 0 0
Spain
State/province [180] 0 0
La Coruña
Country [181] 0 0
Spain
State/province [181] 0 0
Málaga
Country [182] 0 0
Spain
State/province [182] 0 0
Sabadell
Country [183] 0 0
Spain
State/province [183] 0 0
Santiago De Compostela
Country [184] 0 0
Spain
State/province [184] 0 0
Sevilla
Country [185] 0 0
Sweden
State/province [185] 0 0
Uppsala
Country [186] 0 0
Taiwan
State/province [186] 0 0
Taichung
Country [187] 0 0
Taiwan
State/province [187] 0 0
Taoyuan County
Country [188] 0 0
Thailand
State/province [188] 0 0
Bangkok
Country [189] 0 0
Turkey
State/province [189] 0 0
Gaziantep
Country [190] 0 0
Ukraine
State/province [190] 0 0
Dnipro
Country [191] 0 0
Ukraine
State/province [191] 0 0
Kharkiv
Country [192] 0 0
Ukraine
State/province [192] 0 0
Kyiv
Country [193] 0 0
Ukraine
State/province [193] 0 0
Lviv
Country [194] 0 0
Ukraine
State/province [194] 0 0
Simferopol
Country [195] 0 0
Ukraine
State/province [195] 0 0
Vinnytsya
Country [196] 0 0
Ukraine
State/province [196] 0 0
Zaporizhzhya
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Doncaster
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Edinburgh
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Leytonstone
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences and Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01146652