Trial · NCT01146652
Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
NCT01146652, Phase 3, Completed, Sanofi; results first posted 2022-01-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND). Trials, record NCT01146652. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01146652
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
- NCT number
- NCT01146652
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,023 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Rheumatoid Arthritis
- Interventions
- SAR153191 (REGN88)
- First posted
- 2010-06-17
- Last updated
- 2022-03-28
- Other registries' IDs
- eudract:2010-019262-86
- Results first posted
- 2022-01-24
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose (i.e., Day 1 of study LTS11210) up to 60 days after last dose (maximum duration: up to 523 weeks) | 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). |
| 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 | From Week 24 to 36 | 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. |
| Primary | Sub-study: Number of Product Technical Complaints - Product Technical Failures With Pre-filled Syringe With Safety System | From Week 24 to 36 | 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. |
| Primary | Sub-study: Number of Failed Drug Deliveries Associated With Pre-filled Syringe With Safety System | From Week 24 to 36 | 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. |
| Primary | Sub-study: Number of Product Technical Complaints With Pre-filled Syringe With Safety System | From Week 24 to 36 | 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. |
| Secondary | Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response | At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 | 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. |
| Secondary | Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response | At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 | 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. |
| Secondary | Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response | At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 | 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. |
| Secondary | Percentage of Participants With Disease Activity Score for 28 Joints (DAS28) Remission | At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210 | 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. |
| Secondary | Percentage of Participants Achieving Good Response, Moderate Response or Non-response Using the European League Against Rheumatism (EULAR) Response Criteria | At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210 | 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. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose (i.e., Day 1 of study LTS11210) up to 60 days after last dose (maximum duration: up to 523 weeks) | Analysis was performed on safety population which included all enrolled participants who had received at least one dose of the study treatment in LTS11210. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | From Week 24 to 36 | Analysis was performed on all participants who were enrolled in the sub-study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Sub-study: Number of Product Technical Complaints - Product Technical Failures With Pre-filled Syringe With Safety System | From Week 24 to 36 | Analysis was performed on all participants who were enrolled in the sub-study. | PTF | NUMBER |
| PRIMARY | Sub-study: Number of Failed Drug Deliveries Associated With Pre-filled Syringe With Safety System | From Week 24 to 36 | Analysis was performed on all participants who were enrolled in the sub-study. | FDD | NUMBER |
| PRIMARY | Sub-study: Number of Product Technical Complaints With Pre-filled Syringe With Safety System | From Week 24 to 36 | Analysis was performed on all participants who were enrolled in the sub-study. | PTC | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response | At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 | Analysis was performed on safety population which included participants who had at least 1 dose of study treatment in LTS11210. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response | At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 | Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response | At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 | Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Activity Score for 28 Joints (DAS28) Remission | At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210 | Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category and 0 in the number analyzed field denotes that data were not planned to be collected and analyzed for the specified time-points in the respective groups. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Good Response, Moderate Response or Non-response Using the European League Against Rheumatism (EULAR) Response Criteria | At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210 | Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category and 0 in the number analyzed field denotes that data was not planned to be collected and analyzed for the specified time-points in the respective groups. | percentage of participants | NUMBER |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group909
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | Any TEAE | 1760 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Sarilumab Monotherapy | Any TEAE | 98 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | Any TE SAE | 617 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Sarilumab Monotherapy | Any TE SAE | 27 | Participants | |
| 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 | PFS-S Sarilumab 150 mg q2w | PFS-S-associated PTF | 0 | Participants | |
| 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 | PFS-S Sarilumab 200 mg q2w | PFS-S-associated PTF | 0 | Participants | |
| 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 | PFS-S Sarilumab 200 to 150 mg q2w | PFS-S-associated PTF | 0 | Participants | |
| 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 | PFS-S Sarilumab 150 mg q2w | PFS-S-associated FDD | 0 | Participants | |
| 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 | PFS-S Sarilumab 200 mg q2w | PFS-S-associated FDD | 5 | Participants | |
| 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 | PFS-S Sarilumab 200 to 150 mg q2w | PFS-S-associated FDD | 0 | Participants |
1 to 10 of 909Source ClinicalTrials.gov
See all 909 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | 1,912 | |
| Overall Study | STARTED | Sarilumab Monotherapy | 111 | |
| Overall Study | Treated | Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | 1,910 | |
| Overall Study | Treated | Sarilumab Monotherapy | 111 | |
| Overall Study | Enrolled in the Sub-study | Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | 110 | |
| Overall Study | Enrolled in the Sub-study | Sarilumab Monotherapy | 14 | |
| Overall Study | Discontinued From the Sub-study | Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | 1 | |
| Overall Study | Discontinued From the Sub-study | Sarilumab Monotherapy | 2 | |
| Overall Study | Switched Back to Main Study | Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | 108 | |
| Overall Study | Switched Back to Main Study | Sarilumab Monotherapy | 13 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events998
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukopenia | Blood and lymphatic system disorders | Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | 101 | 1,910 | 181 |
| other | Leukopenia | Blood and lymphatic system disorders | Sarilumab Monotherapy | 4 | 111 | 5 |
| other | Neutropenia | Blood and lymphatic system disorders | Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | 348 | 1,910 | 786 |
| other | Neutropenia | Blood and lymphatic system disorders | Sarilumab Monotherapy | 18 | 111 | 64 |
| other | Diarrhoea | Gastrointestinal disorders | Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | 122 | 1,910 | 153 |
| other | Diarrhoea | Gastrointestinal disorders | Sarilumab Monotherapy | 2 | 111 | 2 |
| other | Injection Site Erythema | General disorders | Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | 111 | 1,910 | 751 |
| other | Injection Site Erythema | General disorders | Sarilumab Monotherapy | 0 | 111 | 0 |
| other | Bronchitis | Infections and infestations | Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | 215 | 1,910 | 301 |
| other | Bronchitis | Infections and infestations | Sarilumab Monotherapy | 12 | 111 | 19 |
1 to 10 of 998Source ClinicalTrials.gov
See all 998 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | 49 | 1,910 |
| Total, all-cause mortality | Sarilumab Monotherapy | 3 | 111 |
| Total, other adverse events | Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | 1,444 | 1,910 |
| Total, other adverse events | Sarilumab Monotherapy | 82 | 111 |
| Total, serious adverse events | Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | 617 | 1,910 |
| Total, serious adverse events | Sarilumab Monotherapy | 27 | 111 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) vs Sarilumab Monotherapy: deaths from any cause | Trial comparisons |
| Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) vs Sarilumab Monotherapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01146652
GET https://conductscience.org/api/trials/v1/NCT01146652/registered?page=2