Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01146652
Registration number
NCT01146652
Ethics application status
Date submitted
15/06/2010
Date registered
17/06/2010
Date last updated
28/03/2022
Titles & IDs
Public title
Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
Query!
Scientific title
A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)
Query!
Secondary ID [1]
0
0
2010-019262-86
Query!
Secondary ID [2]
0
0
LTS11210
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Query!
Assessment method [1]
0
0
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).
Query!
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)
Query!
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
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
From Week 24 to 36
Query!
Primary outcome [3]
0
0
Sub-study: Number of Product Technical Complaints - Product Technical Failures With Pre-filled Syringe With Safety System
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
From Week 24 to 36
Query!
Primary outcome [4]
0
0
Sub-study: Number of Failed Drug Deliveries Associated With Pre-filled Syringe With Safety System
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
From Week 24 to 36
Query!
Primary outcome [5]
0
0
Sub-study: Number of Product Technical Complaints With Pre-filled Syringe With Safety System
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
From Week 24 to 36
Query!
Secondary outcome [1]
0
0
Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response
Query!
Assessment method [1]
0
0
ACR20 response: greater than or equal to (>=) 20% improvement in both tender joint count and swollen joint count and, >=20% improvement in at least 3 of the 5 remaining ACR core measures assessments: C-reactive protein [CRP] level (mg/liter [mg/L]); participant's assessment of pain (measured on 0 [no pain] to 100 mm [worst pain] visual analog scale [VAS]); participant's global assessment of disease activity (measured on 0 [no arthritis activity] to 100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity] to 100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by health assessment questionnaire disability index [HAQ-DI], with scoring range of 0 [better physical function] to 3 [worst physical function]). Higher score indicated worse outcomes.
Query!
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
Query!
Secondary outcome [2]
0
0
Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response
Query!
Assessment method [2]
0
0
ACR50 response: >=50% improvement in both TJC and SJC, and >=50% improvement in at least 3 of the 5 remaining ACR core measures assessments: CRP level (in mg/L); participant's assessment of pain (measured on 0 [no pain] to 100 mm [worst pain] VAS); participant's global assessment of disease activity (measured on 0 [no arthritis activity] to 100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity] to 100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by HAQ-DI, with scoring range of 0 [better physical function] to 3 [worst physical function]). Higher score indicated worse outcomes.
Query!
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
Query!
Secondary outcome [3]
0
0
Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response
Query!
Assessment method [3]
0
0
ACR70 response: >=70% improvement in both TJC and SJC, and >=70% improvement in at least 3 of the 5 remaining ACR core measures assessments: CRP level (in mg/L); participant's assessment of pain (measured on 0 [no pain] to 100 mm [worst pain] VAS); participant's global assessment of disease activity (measured on 0 [no arthritis activity]to 100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity] to 100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by HAQ-DI, with scoring range of 0 [better physical function] to 3 [worst physical function]). Higher score indicated worse outcomes.
Query!
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
Query!
Secondary outcome [4]
0
0
Percentage of Participants With Disease Activity Score for 28 Joints (DAS28) Remission
Query!
Assessment method [4]
0
0
Disease activity score based on 28 joints and C-reactive protein (DAS28-CRP) was a composite score which included 4 components: TJC with 28 joints assessed; SJC with 28 joints assessed; high-sensitivity CRP (in mg/L) and general health assessment by the participant using participant global assessment (measured on 0 [no arthritis activity] to 100 mm [maximal arthritis activity] VAS). DAS28-CRP total score ranges from 0 to 10, where higher scores indicated greater disease activity. Percentage of participants with DAS28 remission were reported.
Query!
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
Query!
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
Query!
Assessment method [5]
0
0
DAS28-based EULAR response criteria were used to measure individual response as none, good or moderate, depending on the extent of change from baseline and level of disease activity reached. The EULAR response criteria are defined as:
Good response = change from baseline of >1.2 and a present DAS28-CRP score <=3.2.
Moderate response = change from baseline of >0.6 to <=1.2 and a present DAS28-CRP score <=5.1, or, change from baseline of >1.2 and present DAS28-CRP score >3.2.
Non-response = change from baseline of <=0.6, or change from baseline of >0.6 to <=1.2 and present DAS28-CRP score >5.1.
Scores of good and moderate were considered to indicate therapeutic response. DAS28-CRP is a composite score which included 4 components: TJC with 28 joints assessed; SJC with 28 joints assessed; high-sensitivity CRP (in mg/L) and general health assessment by participant using participant global assessment (measured on 0 [no arthritis activity] to 100 mm [maximal arthritis activity] VAS.
Query!
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
Query!
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
Query!
Assessment method [6]
0
0
DAS28-CRP is a composite score which included 4 components: TJC with 28 joints assessed; SJC with 28 joints assessed; high-sensitivity CRP (in mg/L) and general health assessment by the participant using participant global assessment (measured on 0 [no arthritis activity] to 100 mm [maximal arthritis activity] VAS). DAS28-CRP total score ranges from 0-10, where higher scores indicated greater disease activity. Here, Baseline refers to the Baseline of initial studies (EFC11072, ACT11575, EFC10832, SFY13370 and EFC13752).
Query!
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
Query!
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
Query!
Assessment method [7]
0
0
HAQ-DI is a standardized questionnaire used to assess the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming; arising; eating; walking; hygiene; reach; grip and activities. There were total of 30 items distributed in these 8 domains. Each item was scored on a 4-point scale from 0 to 3, where 0= no difficulty in physical function; 1= some difficulty in physical function; 2= much difficulty in physical function; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty in physical function) to 3 (extreme difficulty in physical function), where higher scores indicate more difficulty while performing daily living activities. Here, Baseline refers to the Baseline of initial studies (EFC11072, ACT11575, EFC10832, SFY13370 and EFC13752).
Query!
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
Query!
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
Query!
Assessment method [8]
0
0
Van der Heijde modified Sharp method is composite X-ray scoring system used to assess structural (joint) disease progression in RA. The method evaluates both joint erosions (JE) for 44 joints and joint space narrowing (JSN) for 42 joints in bilateral hand and foot joints. Total mTSS: sum of the scores from both erosion score and joint space narrowing score and ranged from 0 (normal, no progression) to 448 (worst possible total score). An increase in total score represents progression of structural damage. Here, Baseline refers to the Baseline of initial study (EFC11072 Part B). In this outcome measure, change from initial study Baseline in 2 years X-ray data at Week 0 and 48 of LTS11210 were reported.
Query!
Timepoint [8]
0
0
Baseline, Week 0 and 48 of LTS11210
Query!
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
Query!
Assessment method [9]
0
0
Van der Heijde modified Sharp method is composite X-ray scoring system used to assess structural (joint) disease progression in RA. The method evaluates both JE for 44 joints and JSN for 42 joints in bilateral hand and foot joints. Total mTSS: sum of the scores from both erosion score and joint space narrowing score and ranged from 0 (normal, no progression) to 448 (worst possible total score). An increase in total score represents progression of structural damage. Here, Baseline refers to the Baseline of initial study (EFC11072 Part B). In this outcome measure, change from initial study (EFC11072 Part B) Baseline in 3 years X-ray data (participants with study duration of more than 48 weeks in LTS11210) at Week 48 and 96 of LTS11210 from Campaign 2 were reported.
Query!
Timepoint [9]
0
0
Baseline, Week 48 and 96 of LTS11210
Query!
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
Query!
Assessment method [10]
0
0
Van der Heijde modified Sharp method is composite X-ray scoring system used to assess structural (joint) disease progression in RA. The method evaluates both JE for 44 joints and JSN for 42 joints in bilateral hand and foot joints. Total mTSS: sum of the scores from both erosion score and joint space narrowing score and ranged from 0 (normal, no progression) to 448 (worst possible total score). An increase in total score represents progression of structural damage. Here, Baseline refers to the Baseline of initial study (EFC11072 Part B). In this outcome measure, change from initial study (EFC11072 Part B) Baseline in 5 years X-ray data (participants with study duration of more than 96 weeks in LTS11210) at Week 96, 144 and 192 of LTS11210 from Campaign 3 were reported.
Query!
Timepoint [10]
0
0
Baseline, Week 96, 144 and 192 of LTS11210
Query!
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
Query!
Assessment method [11]
0
0
Radiographic no progression: defined as a change from Baseline in Van der Heijde mTSS <= 0. Van der Heijde modified Sharp method is composite X-ray scoring system used to assess structural (joint) disease progression in RA. The method evaluates both JE for 44 joints and JSN for 42 joints in bilateral hand and foot joints. Total mTSS was sum of scores from both erosion score and joint space narrowing score, ranged from 0 (normal, no progression) to 448 (worst possible total score). Increase in total score represents progression of structural damage. In this outcome measure, percentage of participants with no radiographic progression at Week 48 of LTS11210 from Campaign 1 X-ray data were reported.
Query!
Timepoint [11]
0
0
Week 0 (post-dose) and 48 of LTS11210
Query!
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
Query!
Assessment method [12]
0
0
Radiographic no progression: defined as a change from Baseline in Van der Heijde mTSS <= 0. Van der Heijde modified Sharp method is composite X-ray scoring system used to assess structural (joint) disease progression in RA. The method evaluates both JE for 44 joints and JSN for 42 joints in bilateral hand and foot joints. Total mTSS was sum of scores from both erosion score and joint space narrowing score, ranged from 0 (normal, no progression) to 448 (worst possible total score). Increase in total score represents progression of structural damage. In this outcome measure, percentage of participants with no radiographic progression at Week 48 and 96 of LTS11210 from Campaign 2 X-ray data (participants with study duration of more than 48 weeks in LTS11210) were reported.
Query!
Timepoint [12]
0
0
Week 48 and 96 of LTS11210
Query!
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
Query!
Assessment method [13]
0
0
Radiographic no progression: defined as a change from Baseline in Van der Heijde mTSS <= 0. Van der Heijde modified Sharp method is composite X-ray scoring system used to assess structural (joint) disease progression in RA. The method evaluates both JE for 44 joints and JSN for 42 joints in bilateral hand and foot joints. Total mTSS was sum of scores from both erosion score and joint space narrowing score, ranged from 0 (normal, no progression) to 448 (worst possible total score). Increase in total score represents progression of structural damage. In this outcome measure, percentage of participants with no radiographic progression at Week 96, 144 and 192 of LTS11210 from Campaign 3 X-ray data (participants with study duration more than 96 weeks in LTS11210) were reported.
Query!
Timepoint [13]
0
0
Week 96, 144 and 192 of LTS11210
Query!
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
Query!
Assessment method [14]
0
0
TJC is the sum of all tender joints based on examination of the 68 joints of the fingers, elbows, hips, knees, ankles, and toes. Total TJC ranged from 0 (best) to 68 (worst), where higher score = more severity. Change from Baseline in TJC was reported in the outcome measure. Here, Baseline refers to Baseline of initial study (EFC11072, ACT11575, EFC10832, SFY13370 and EFC13752).
Query!
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
Query!
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
Query!
Assessment method [15]
0
0
SJC is the sum of all swollen joints based on examination of the fingers, elbows, knees and toes. Total SJC ranged from 0 (best) to 66 (worst), where higher score = more severity. Change from Baseline in SJC was reported in the outcome measure. Here, Baseline refers to the Baseline of initial studies (EFC11072, ACT11575, EFC10832, SFY13370 and EFC13752).
Query!
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
Query!
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
Query!
Assessment method [16]
0
0
Physician global assessment of disease activity was measured on a 100 millimeters (mm) horizontal VAS, ranging from 0 (best disease activity) to 100 (worst disease activity), where lower score = less disease activity and higher score = more disease activity. Here, Baseline refers to Baseline of initial studies (EFC11072, ACT11575, EFC10832, SFY13370 and EFC13752).
Query!
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
Query!
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
Query!
Assessment method [17]
0
0
Participant global assessment of disease activity was measured on a 100 mm horizontal VAS, ranging from 0 (best disease activity) to 100 (worst disease activity), where lower score = less disease activity and higher score = more disease activity. Here, Baseline refers to the Baseline of initial studies (EFC11072, ACT11575, EFC10832, SFY13370 and EFC13752).
Query!
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
Query!
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
Query!
Assessment method [18]
0
0
Participants were requested to indicate their pain intensity due to their RA on a 100 mm horizontal VAS, ranging from 0 (no pain) to 100 (worst pain), where a higher score represented more pain due to RA. Here, Baseline refers to the Baseline of initial studies (EFC11072, ACT11575, EFC10832, SFY13370 and EFC13752).
Query!
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
Query!
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
Query!
Assessment method [19]
0
0
SF-36 is a generic 36-item questionnaire consisting of 8 domains, measuring quality of life (QoL) covering 2 summary measures: PCS and mental component summary (MCS). PCS with 4 domains: physical functioning, role limitations due to physical problems, bodily pain, and general health; and MCS with 4 domains: vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored by summing the individual items, which are transformed into a score range from 0 to 100; where 0= worst QoL to 100=best QoL. PCS total score ranged from 0 to 100 with higher scores indicating better physical health. Here, Baseline refers to the Baseline of initial studies (EFC11072, ACT11575, and EFC10832).
Query!
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
Query!
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
Query!
Assessment method [20]
0
0
SF-36 is a generic 36-item questionnaire consisting of 8 domains, measuring quality of life (QoL) covering 2 summary measures: PCS and MCS. PCS with 4 domains: physical functioning, role limitations due to physical problems, bodily pain, and general health; and MCS with 4 domains: vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored by summing the individual items, which are transformed into a score range from 0 to 100; 0= worst QoL to 100=best QoL. MCS total score ranged from 0 to 100 with higher scores indicating better physical and mental health. Here, Baseline refers to the Baseline of initial studies (EFC11072, ACT11575, and EFC10832).
Query!
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
Query!
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
Query!
Assessment method [21]
0
0
The FACIT-F is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0 to 4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. The sum of all responses resulted in the FACIT-Fatigue total score ranged from 0 to 52, where higher score = lower level of fatigue and indicates better QoL. A positive change from baseline score indicates an improvement. Here, Baseline refers to the Baseline of initial studies (EFC11072, ACT11575, and EFC10832).
Query!
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
Query!
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
Query!
Assessment method [22]
0
0
Rheumatoid arthritis (RA), like other chronic illness, is associated with sleep disturbances and is linked to pain, mood, and disease activity. The effect of sarilumab on sleep was assessed on a on 100 mm horizontal VAS scale, ranging from 0 (sleep is not a problem) to 100 (sleep is a major problem), where higher score = more sleep disturbances. Here, Baseline refers to the Baseline of initial studies (EFC11072, and ACT11575).
Query!
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
Query!
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
Query!
Assessment method [23]
0
0
WPAI assesses work productivity and impairment. It is 6-item questionnaire used to assess degree to which RA affected work productivity and regular activities over past 7 days. Questions were: Q1 = currently employed; Q2 = hours missed due to RA; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree problem affected productivity while working (0 to 10 scale, with higher numbers indicated less productivity); Q6 = degree problem affected regular activities (0 to 10 scale, with higher numbers indicated greater impairment). The percent work time missed due to RA was a subscale and calculated as: 100*Q2/(Q2+Q4) for those who were currently employed. Subscale score was expressed as impairment percentage (range:0 to 100%) where higher numbers indicate greater impairment and less productivity. Here, Baseline refers to Baseline of initial studies (EFC11072 and ACT11575).
Query!
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
Query!
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
Query!
Assessment method [24]
0
0
WPAI assesses work productivity and impairment. It is 6-item questionnaire used to assess degree to which RA affected work productivity and regular activities over past 7 days. Questions were: Q1 = currently employed; Q2 = hours missed due to RA; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree problem affected productivity while working (0 to 10 scale, with higher numbers = less productivity); Q6 = degree problem affected regular activities (0 to 10 scale, with higher numbers = greater impairment). Percentage impairment while working due to RA was subscale and calculated as: 10*Q5 for those who were currently employed and actually worked in past 7 days. Subscale score=expressed as impairment percentage (range:0 to 100%), where higher numbers=greater impairment and less productivity. Here, Baseline refers to the Baseline of initial studies (EFC11072 and ACT11575).
Query!
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
Query!
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
Query!
Assessment method [25]
0
0
WPAI assesses work productivity and impairment. It is 6-item questionnaire used to assess degree to which RA affected work productivity and regular activities over past 7 days. Questions were: Q1 = currently employed; Q2 = hours missed due to RA; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree problem affected productivity while working (0 to 10 scale, with higher numbers indicated less productivity); Q6 = degree problem affected regular activities (0 10 scale, with higher numbers indicated greater impairment). Percent overall work impairment due to RA was subscale and calculated as: 100*Q2/(Q2+Q4)+100*[(1- Q2/(Q2+Q4))*(Q5/10)] for those who were currently employed . Subscale score = expressed as impairment percentage (range: 0 to 100%) where higher numbers indicate greater impairment. Here, Baseline refers to Baseline of initial studies (EFC11072 and ACT11575).
Query!
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
Query!
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
Query!
Assessment method [26]
0
0
WPAI assesses work productivity and impairment. It is 6-item questionnaire used to assess degree to which RA affected work productivity and regular activities over past 7 days. Questions were: Q1 = currently employed; Q2 = hours missed due to RA; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree problem affected productivity while working (0 to 10 scale, with higher numbers indicated less productivity); Q6 = degree problem affected regular activities (0 10 scale, with higher numbers indicated greater impairment). Percent activity impairment due to RA was a subscale and calculated as: 10*Q6 for all respondents. Subscale score=expressed as impairment percentage (range: 0 to 100%) where higher numbers indicate greater impairment. Here, Baseline refers to Baseline of initial studies (EFC11072 and ACT11575).
Query!
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
Query!
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
Query!
Assessment method [27]
0
0
The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with arthritis over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Change from Baseline in number of work days missed in the last month due to arthritis by the participant was reported in the outcome measure. Here, Baseline refers to the Baseline of initial study (EFC10832).
Query!
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
Query!
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
Query!
Assessment method [28]
0
0
The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Change from Baseline in number of work days with reduced productivity by >= 50% in the last month by the participant was reported in the outcome measure. Here, Baseline refers to the Baseline of initial study (EFC10832).
Query!
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
Query!
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
Query!
Assessment method [29]
0
0
The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Interference in the last month with work productivity was measured on a scale that ranged from 0 (no interference) to 10 (complete interference), where higher scores indicated more interference. Here, Baseline refers to the Baseline of initial study (EFC10832).
Query!
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
Query!
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
Query!
Assessment method [30]
0
0
'The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Change from baseline in number of days with no household work/household work missed in the last month by the participants was reported. Here, Baseline refers to the Baseline of initial study (EFC10832).
Query!
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
Query!
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
Query!
Assessment method [31]
0
0
The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Change from baseline in number of days with reduced household work productivity by >= 50% in the last month by the participants was reported. Here, Baseline refers to the Baseline of initial study (EFC10832).
Query!
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
Query!
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
Query!
Assessment method [32]
0
0
The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Change from baseline in number of days missed of family/social/leisure activities in the last month by the participants was reported. Here, Baseline refers to the Baseline of initial study (EFC10832).
Query!
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
Query!
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
Query!
Assessment method [33]
0
0
The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Change from baseline in number of days with outside help hired in the last month by the participant was reported. Here, Baseline refers to the Baseline of initial study (EFC10832).
Query!
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
Query!
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
Query!
Assessment method [34]
0
0
The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). The RA interference in the last month with household work productivity was measured on a scale that ranged from 0 (no interference) to 10 (complete interference), where higher scores indicated more interference. Here, Baseline refers to the Baseline of initial study (EFC10832).
Query!
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
Query!
Secondary outcome [35]
0
0
Sub-study: Number of Participants Who Reported Adverse Events Related to Pre-filled Syringe With Safety System
Query!
Assessment method [35]
0
0
AEs related to PFS-S included PTC-related AEs, device-related AEs, or AEs of injection site reaction. In this outcome measure, only PTC-related AEs, device-related AEs, or AEs of injection site reaction assessed during the sub-study were reported. TEAEs and SAEs reported during the sub-study were included in the main study data and no separate data collection and analysis was performed, as pre-planned in the protocol .
Query!
Timepoint [35]
0
0
From Week 24 to 36
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/06/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
31/12/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
2023
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Investigational Site Number 036003 - Camperdown
Query!
Recruitment hospital [2]
0
0
Investigational Site Number 036012 - Fitzroy
Query!
Recruitment hospital [3]
0
0
Investigational Site Number 036010 - Garran
Query!
Recruitment hospital [4]
0
0
Investigational Site Number 036004 - Heidelberg West
Query!
Recruitment hospital [5]
0
0
Investigational Site Number 036001 - Maroochydore
Query!
Recruitment hospital [6]
0
0
Investigational Site Number 036014 - Victoria Park
Query!
Recruitment hospital [7]
0
0
Investigational Site Number 036007 - Woodville
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [3]
0
0
2605 - Garran
Query!
Recruitment postcode(s) [4]
0
0
3081 - Heidelberg West
Query!
Recruitment postcode(s) [5]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [6]
0
0
6100 - Victoria Park
Query!
Recruitment postcode(s) [7]
0
0
5011 - Woodville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Delaware
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Idaho
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kansas
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kentucky
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Louisiana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Maryland
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Massachusetts
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Michigan
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nebraska
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Jersey
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New York
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
North Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
North Dakota
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Oklahoma
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Pennsylvania
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
South Carolina
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Tennessee
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Texas
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Washington
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
West Virginia
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
Caba
Query!
Country [29]
0
0
Argentina
Query!
State/province [29]
0
0
Capital Federal
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
Cordoba
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Córdoba
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
La Plata
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Mar Del Plata
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Quilmes
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Ramos Mejia
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Rosario
Query!
Country [37]
0
0
Argentina
Query!
State/province [37]
0
0
San Fernando
Query!
Country [38]
0
0
Argentina
Query!
State/province [38]
0
0
San Miguel De Tucuman
Query!
Country [39]
0
0
Argentina
Query!
State/province [39]
0
0
Zarate
Query!
Country [40]
0
0
Austria
Query!
State/province [40]
0
0
Graz
Query!
Country [41]
0
0
Belarus
Query!
State/province [41]
0
0
Minsk
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Leuven
Query!
Country [43]
0
0
Brazil
Query!
State/province [43]
0
0
Curitiba
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
Goiania
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
Juiz De Fora
Query!
Country [46]
0
0
Brazil
Query!
State/province [46]
0
0
Porto Alegre
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
Rio De Janeiro
Query!
Country [48]
0
0
Brazil
Query!
State/province [48]
0
0
Salvador
Query!
Country [49]
0
0
Brazil
Query!
State/province [49]
0
0
Sao Paulo
Query!
Country [50]
0
0
Brazil
Query!
State/province [50]
0
0
Vitoria
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
Mississauga
Query!
Country [52]
0
0
Canada
Query!
State/province [52]
0
0
St. Catharines
Query!
Country [53]
0
0
Canada
Query!
State/province [53]
0
0
Toronto
Query!
Country [54]
0
0
Canada
Query!
State/province [54]
0
0
Trois-Rivières
Query!
Country [55]
0
0
Canada
Query!
State/province [55]
0
0
Victoria
Query!
Country [56]
0
0
Canada
Query!
State/province [56]
0
0
Winnipeg
Query!
Country [57]
0
0
Chile
Query!
State/province [57]
0
0
Osorno
Query!
Country [58]
0
0
Chile
Query!
State/province [58]
0
0
Santiago
Query!
Country [59]
0
0
Chile
Query!
State/province [59]
0
0
Talca
Query!
Country [60]
0
0
Chile
Query!
State/province [60]
0
0
Temuco IX Region
Query!
Country [61]
0
0
Chile
Query!
State/province [61]
0
0
Valdivia
Query!
Country [62]
0
0
Chile
Query!
State/province [62]
0
0
Vina Del Mar
Query!
Country [63]
0
0
Chile
Query!
State/province [63]
0
0
Viña Del Mar
Query!
Country [64]
0
0
Colombia
Query!
State/province [64]
0
0
Barranquilla
Query!
Country [65]
0
0
Colombia
Query!
State/province [65]
0
0
Bogota
Query!
Country [66]
0
0
Colombia
Query!
State/province [66]
0
0
Bogotá
Query!
Country [67]
0
0
Colombia
Query!
State/province [67]
0
0
Bucaramanga
Query!
Country [68]
0
0
Czechia
Query!
State/province [68]
0
0
Liberec
Query!
Country [69]
0
0
Czechia
Query!
State/province [69]
0
0
Ostrava
Query!
Country [70]
0
0
Czechia
Query!
State/province [70]
0
0
Pardubice
Query!
Country [71]
0
0
Czechia
Query!
State/province [71]
0
0
Praha 2
Query!
Country [72]
0
0
Czechia
Query!
State/province [72]
0
0
Praha 4
Query!
Country [73]
0
0
Czechia
Query!
State/province [73]
0
0
Uherske Hradiste
Query!
Country [74]
0
0
Czechia
Query!
State/province [74]
0
0
Zlin
Query!
Country [75]
0
0
Ecuador
Query!
State/province [75]
0
0
Cuenca
Query!
Country [76]
0
0
Ecuador
Query!
State/province [76]
0
0
Guayaquil
Query!
Country [77]
0
0
Ecuador
Query!
State/province [77]
0
0
Quito
Query!
Country [78]
0
0
Estonia
Query!
State/province [78]
0
0
Tallinn
Query!
Country [79]
0
0
Finland
Query!
State/province [79]
0
0
Helsinki
Query!
Country [80]
0
0
Finland
Query!
State/province [80]
0
0
Hyvinkää
Query!
Country [81]
0
0
Finland
Query!
State/province [81]
0
0
Pori
Query!
Country [82]
0
0
Finland
Query!
State/province [82]
0
0
Riihimäki
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Bad Nauheim
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Berlin
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Deggingen
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Halle/Saale
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Hamburg
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Herne
Query!
Country [89]
0
0
Germany
Query!
State/province [89]
0
0
Leipzig
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
München
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Osnabrück
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Tübingen
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Zerbst
Query!
Country [94]
0
0
Greece
Query!
State/province [94]
0
0
Heraklion
Query!
Country [95]
0
0
Greece
Query!
State/province [95]
0
0
Thessaloniki
Query!
Country [96]
0
0
Guatemala
Query!
State/province [96]
0
0
Guatemala City
Query!
Country [97]
0
0
Guatemala
Query!
State/province [97]
0
0
Guatemala
Query!
Country [98]
0
0
Hungary
Query!
State/province [98]
0
0
Budapest
Query!
Country [99]
0
0
Hungary
Query!
State/province [99]
0
0
Debrecen
Query!
Country [100]
0
0
Hungary
Query!
State/province [100]
0
0
Esztergom
Query!
Country [101]
0
0
Hungary
Query!
State/province [101]
0
0
Györ
Query!
Country [102]
0
0
Hungary
Query!
State/province [102]
0
0
Szolnok
Query!
Country [103]
0
0
Hungary
Query!
State/province [103]
0
0
Szombathely
Query!
Country [104]
0
0
Hungary
Query!
State/province [104]
0
0
Székesfehérvár
Query!
Country [105]
0
0
Hungary
Query!
State/province [105]
0
0
Sátoraljaújhely
Query!
Country [106]
0
0
Israel
Query!
State/province [106]
0
0
Haifa
Query!
Country [107]
0
0
Israel
Query!
State/province [107]
0
0
Tel Aviv
Query!
Country [108]
0
0
Israel
Query!
State/province [108]
0
0
Tel Hashomer
Query!
Country [109]
0
0
Italy
Query!
State/province [109]
0
0
Genova
Query!
Country [110]
0
0
Korea, Republic of
Query!
State/province [110]
0
0
Anyang-Si
Query!
Country [111]
0
0
Korea, Republic of
Query!
State/province [111]
0
0
Busan
Query!
Country [112]
0
0
Korea, Republic of
Query!
State/province [112]
0
0
Daegu
Query!
Country [113]
0
0
Korea, Republic of
Query!
State/province [113]
0
0
Daejeon
Query!
Country [114]
0
0
Korea, Republic of
Query!
State/province [114]
0
0
Gwangju
Query!
Country [115]
0
0
Korea, Republic of
Query!
State/province [115]
0
0
Incheon
Query!
Country [116]
0
0
Korea, Republic of
Query!
State/province [116]
0
0
Jeonju
Query!
Country [117]
0
0
Korea, Republic of
Query!
State/province [117]
0
0
Seoul
Query!
Country [118]
0
0
Korea, Republic of
Query!
State/province [118]
0
0
Suwon
Query!
Country [119]
0
0
Lithuania
Query!
State/province [119]
0
0
Kaunas
Query!
Country [120]
0
0
Lithuania
Query!
State/province [120]
0
0
Klaipeda
Query!
Country [121]
0
0
Lithuania
Query!
State/province [121]
0
0
Vilnius
Query!
Country [122]
0
0
Malaysia
Query!
State/province [122]
0
0
Ipoh
Query!
Country [123]
0
0
Malaysia
Query!
State/province [123]
0
0
Kuching
Query!
Country [124]
0
0
Mexico
Query!
State/province [124]
0
0
Chihuahua
Query!
Country [125]
0
0
Mexico
Query!
State/province [125]
0
0
Durango
Query!
Country [126]
0
0
Mexico
Query!
State/province [126]
0
0
Guadalajara
Query!
Country [127]
0
0
Mexico
Query!
State/province [127]
0
0
Leon
Query!
Country [128]
0
0
Mexico
Query!
State/province [128]
0
0
Merida
Query!
Country [129]
0
0
Mexico
Query!
State/province [129]
0
0
Metepec
Query!
Country [130]
0
0
Mexico
Query!
State/province [130]
0
0
Mexicali
Query!
Country [131]
0
0
Mexico
Query!
State/province [131]
0
0
Mexico City
Query!
Country [132]
0
0
Mexico
Query!
State/province [132]
0
0
Monterrey
Query!
Country [133]
0
0
Mexico
Query!
State/province [133]
0
0
Mérida
Query!
Country [134]
0
0
Mexico
Query!
State/province [134]
0
0
México, D.F.
Query!
Country [135]
0
0
Mexico
Query!
State/province [135]
0
0
México
Query!
Country [136]
0
0
Mexico
Query!
State/province [136]
0
0
Queretaro
Query!
Country [137]
0
0
Netherlands
Query!
State/province [137]
0
0
Amsterdam
Query!
Country [138]
0
0
New Zealand
Query!
State/province [138]
0
0
Christchurch
Query!
Country [139]
0
0
New Zealand
Query!
State/province [139]
0
0
Nelson
Query!
Country [140]
0
0
New Zealand
Query!
State/province [140]
0
0
Otahuhu
Query!
Country [141]
0
0
New Zealand
Query!
State/province [141]
0
0
Rotorua
Query!
Country [142]
0
0
New Zealand
Query!
State/province [142]
0
0
Timaru
Query!
Country [143]
0
0
Peru
Query!
State/province [143]
0
0
Lima
Query!
Country [144]
0
0
Philippines
Query!
State/province [144]
0
0
Cebu City
Query!
Country [145]
0
0
Philippines
Query!
State/province [145]
0
0
Manila
Query!
Country [146]
0
0
Poland
Query!
State/province [146]
0
0
Bialystok
Query!
Country [147]
0
0
Poland
Query!
State/province [147]
0
0
Bydgoszcz
Query!
Country [148]
0
0
Poland
Query!
State/province [148]
0
0
Bytom
Query!
Country [149]
0
0
Poland
Query!
State/province [149]
0
0
Elblag
Query!
Country [150]
0
0
Poland
Query!
State/province [150]
0
0
Krakow
Query!
Country [151]
0
0
Poland
Query!
State/province [151]
0
0
Lublin
Query!
Country [152]
0
0
Poland
Query!
State/province [152]
0
0
Poznan
Query!
Country [153]
0
0
Poland
Query!
State/province [153]
0
0
Szczecin
Query!
Country [154]
0
0
Poland
Query!
State/province [154]
0
0
Torun
Query!
Country [155]
0
0
Poland
Query!
State/province [155]
0
0
Warszawa
Query!
Country [156]
0
0
Poland
Query!
State/province [156]
0
0
Wroclaw
Query!
Country [157]
0
0
Portugal
Query!
State/province [157]
0
0
Lisboa
Query!
Country [158]
0
0
Romania
Query!
State/province [158]
0
0
Braila
Query!
Country [159]
0
0
Romania
Query!
State/province [159]
0
0
Bucharest
Query!
Country [160]
0
0
Romania
Query!
State/province [160]
0
0
Bucuresti
Query!
Country [161]
0
0
Romania
Query!
State/province [161]
0
0
Galati
Query!
Country [162]
0
0
Russian Federation
Query!
State/province [162]
0
0
Kemerovo
Query!
Country [163]
0
0
Russian Federation
Query!
State/province [163]
0
0
Moscow
Query!
Country [164]
0
0
Russian Federation
Query!
State/province [164]
0
0
Novosibirsk
Query!
Country [165]
0
0
Russian Federation
Query!
State/province [165]
0
0
Ryazan
Query!
Country [166]
0
0
Russian Federation
Query!
State/province [166]
0
0
Saint-Petersburg
Query!
Country [167]
0
0
Russian Federation
Query!
State/province [167]
0
0
Samara
Query!
Country [168]
0
0
Russian Federation
Query!
State/province [168]
0
0
Saratov
Query!
Country [169]
0
0
Russian Federation
Query!
State/province [169]
0
0
St-Petersburg
Query!
Country [170]
0
0
Russian Federation
Query!
State/province [170]
0
0
Ufa
Query!
Country [171]
0
0
South Africa
Query!
State/province [171]
0
0
Cape Town
Query!
Country [172]
0
0
South Africa
Query!
State/province [172]
0
0
Durban
Query!
Country [173]
0
0
South Africa
Query!
State/province [173]
0
0
Johannesburg
Query!
Country [174]
0
0
South Africa
Query!
State/province [174]
0
0
Kempton Park
Query!
Country [175]
0
0
South Africa
Query!
State/province [175]
0
0
Pretoria
Query!
Country [176]
0
0
South Africa
Query!
State/province [176]
0
0
Stellenbosch
Query!
Country [177]
0
0
Spain
Query!
State/province [177]
0
0
Barakaldo
Query!
Country [178]
0
0
Spain
Query!
State/province [178]
0
0
Barcelona
Query!
Country [179]
0
0
Spain
Query!
State/province [179]
0
0
Cádiz
Query!
Country [180]
0
0
Spain
Query!
State/province [180]
0
0
La Coruña
Query!
Country [181]
0
0
Spain
Query!
State/province [181]
0
0
Málaga
Query!
Country [182]
0
0
Spain
Query!
State/province [182]
0
0
Sabadell
Query!
Country [183]
0
0
Spain
Query!
State/province [183]
0
0
Santiago De Compostela
Query!
Country [184]
0
0
Spain
Query!
State/province [184]
0
0
Sevilla
Query!
Country [185]
0
0
Sweden
Query!
State/province [185]
0
0
Uppsala
Query!
Country [186]
0
0
Taiwan
Query!
State/province [186]
0
0
Taichung
Query!
Country [187]
0
0
Taiwan
Query!
State/province [187]
0
0
Taoyuan County
Query!
Country [188]
0
0
Thailand
Query!
State/province [188]
0
0
Bangkok
Query!
Country [189]
0
0
Turkey
Query!
State/province [189]
0
0
Gaziantep
Query!
Country [190]
0
0
Ukraine
Query!
State/province [190]
0
0
Dnipro
Query!
Country [191]
0
0
Ukraine
Query!
State/province [191]
0
0
Kharkiv
Query!
Country [192]
0
0
Ukraine
Query!
State/province [192]
0
0
Kyiv
Query!
Country [193]
0
0
Ukraine
Query!
State/province [193]
0
0
Lviv
Query!
Country [194]
0
0
Ukraine
Query!
State/province [194]
0
0
Simferopol
Query!
Country [195]
0
0
Ukraine
Query!
State/province [195]
0
0
Vinnytsya
Query!
Country [196]
0
0
Ukraine
Query!
State/province [196]
0
0
Zaporizhzhya
Query!
Country [197]
0
0
United Kingdom
Query!
State/province [197]
0
0
Doncaster
Query!
Country [198]
0
0
United Kingdom
Query!
State/province [198]
0
0
Edinburgh
Query!
Country [199]
0
0
United Kingdom
Query!
State/province [199]
0
0
Leytonstone
Query!
Country [200]
0
0
United Kingdom
Query!
State/province [200]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Sanofi
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Regeneron Pharmaceuticals
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01146652
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Sciences and Operations
Query!
Address
0
0
Sanofi
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01146652
Download to PDF