Phase 3
Completed N=2,023
Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
Source: ClinicalTrials.gov NCT01146652 ↗Enrolled (actual)
2,023
Serious AEs
31.9%
Results posted
Jan 2022
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 1760; 98; 617; 27 Participants
◆ Published Evidence
Established
40citations · ~6 / year
Long-term safety and efficacy of sarilumab plus methotrexate on disease activity, physical function and radiographic progression: 5 years of sarilumab plus methotrexate treatment.
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.
Linked Publications (5)
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Long-term safety and efficacy of sarilumab plus methotrexate on disease activity, physical function and radiographic progression: 5 years of sarilumab plus methotrexate treatment.
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Disproportionate articular pain is a frequent phenomenon in rheumatoid arthritis and responds to treatment with sarilumab.
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Long-term safety and efficacy of sarilumab over 5 years in patients with rheumatoid arthritis refractory to TNF inhibitors.
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Subcutaneous Sarilumab in Patients With Rheumatoid Arthritis who Previously Received Subcutaneous Sarilumab or Intravenous Tocilizumab: An Open-Label Extension of a Randomized Clinical Trial.
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Long-term safety and efficacy of sarilumab with or without background csDMARDs in rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
1760; 98; 617; 27 | — |
| PRIMARY 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 |
0; 0; 0; 0; 5; 0 | — |
| PRIMARY Sub-study: Number of Product Technical Complaints - Product Technical Failures With Pre-filled Syringe With Safety System |
0; 0; 0 | — |
| PRIMARY Sub-study: Number of Failed Drug Deliveries Associated With Pre-filled Syringe With Safety System |
0; 5; 0 | — |
| PRIMARY Sub-study: Number of Product Technical Complaints With Pre-filled Syringe With Safety System |
0; 5; 0 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response |
69.4; 82.0; 77.8; 85.8; 80.2; 92.5 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response |
43.4; 58.6; 51.3; 59.3; 55.1; 59.0 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response |
22.9; 32.4; 27.8; 31.5; 32.1; 36.2 | — |
| SECONDARY Percentage of Participants With Disease Activity Score for 28 Joints (DAS28) Remission |
30.4; 46.4; 39.2; 51.9; 44.6; 49.5 | — |
| SECONDARY Percentage of Participants Achieving Good Response, Moderate Response or Non-response Using the European League Against Rheumatism (EULAR) Response Criteria |
44.7; 60.9; 40.3; 30.9; 15.0; 8.2 | — |
| SECONDARY 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 |
-2.50; -2.99; -2.98; -3.18; -3.12; -3.21 | — |
| SECONDARY 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 |
-0.56; -0.58; -0.59; -0.57; -0.63; -0.63 | — |
| SECONDARY 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 |
1.05; 1.34 | — |
| SECONDARY 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 |
1.60; 2.14 | — |
| SECONDARY 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 |
1.83; 2.24; 2.83 | — |
| SECONDARY 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 |
51.9; 51.2 | — |
| SECONDARY 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 |
46.6; 44.2 | — |
| SECONDARY 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 |
48.6; 46.0; 41.8 | — |
| SECONDARY 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 |
-16.67; -19.86; -18.97; -20.13; -19.72; -20.09 | — |
| SECONDARY 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 |
-11.36; -14.06; -12.81; -14.55; -13.43; -14.60 | — |
| SECONDARY 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 |
-40.51; -46.38; -43.98; -47.94; -45.79; -49.27 | — |
| SECONDARY 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 |
-30.51; -32.30; -32.87; -33.63; -34.65; -34.25 | — |
| SECONDARY 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 |
-31.08; -37.01; -34.04; -37.53; -35.79; -38.14 | — |
| SECONDARY 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 |
7.95; 8.84; 9.25; 9.72; 9.43; 9.64 | — |
| SECONDARY 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 |
6.43; 7.15; 7.43; 7.20; 7.48; 7.43 | — |
| SECONDARY 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 |
9.20; 10.26; 10.94; 10.91; 10.86; 10.97 | — |
| SECONDARY 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 |
-24.58; -26.11; -26.44; -27.37; -26.15; -26.98 | — |
| SECONDARY 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 |
-10.82; -8.62; -11.92; -9.62; -11.39; -10.03 | — |
| SECONDARY 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 |
-21.65; -22.16; -23.45; -27.01; -24.76; -25.17 | — |
| SECONDARY 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 |
-22.84; -23.13; -25.39; -28.13; -24.72; -26.44 | — |
| SECONDARY 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 |
-26.47; -28.02; -28.76; -29.71; -29.11; -29.81 | — |
| SECONDARY 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 |
-2.72; -3.66; -3.70; -3.73; -3.37; -3.55 | — |
| SECONDARY 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 |
-3.47; -4.93; -5.14; -5.47; -5.75; -5.16 | — |
| SECONDARY 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 |
-20.83; -27.95; -35.16; -37.48; -36.78; -40.35 | — |
| SECONDARY 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 |
-4.65; -6.17; -6.55; -6.65; -6.61; -6.84 | — |
| SECONDARY 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 |
-4.08; -5.64; -6.01; -6.57; -7.06; -7.01 | — |
| SECONDARY 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 |
-2.94; -4.16; -4.50; -4.38; -4.44; -4.46 | — |
| SECONDARY 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 |
-2.92; -4.24; -4.12; -4.28; -4.58; -4.21 | — |
| SECONDARY 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 |
-23.24; -33.49; -36.94; -36.42; -37.45; -38.19 | — |
| SECONDARY Sub-study: Number of Participants Who Reported Adverse Events Related to Pre-filled Syringe With Safety System |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion criteria
Main study:
Participants with RA who were previously randomized in the sarilumab RA clinical program: e.g., the EFC11072 study, ACT11575 study, EFC10832 study, SFY13370, and EFC13752 study.
Sub-study:
Participants enrolled in the LTS11210 study who were receiving either sarilumab 200mg q2w PFS or sarilumab 150mg q2w PFS and who were able and willing to participate in this sub-study.
Participants who had been enrolled in the main study for at least 24 weeks. Participants must sign a sub-study written informed consent prior to any sub-study related procedure.
Exclusion criteria
Main study:
Participants with any adverse event (AE) led to permanent study drug discontinuation from a prior study.
Participants with an abnormality(ies) or AEs that per investigator judgment would adversely affect participation of the participant in the study.
Sub-study: There are no additional exclusion criteria to those defined in main study.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT01146652) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.