Trial · NCT01709578
To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)
NCT01709578, Phase 3, Completed, Sanofi; results first posted 2017-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET). Trials, record NCT01709578. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01709578
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)
- NCT number
- NCT01709578
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 546 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Rheumatoid Arthritis
- Interventions
- Sarilumab, placebo, hydroxychloroquine, methotrexate, sulfasalazine, leflunomide
- First posted
- 2012-10-18
- Last updated
- 2017-08-08
- Other registries' IDs
- eudract:2011-003538-16
- Results first posted
- 2017-08-08
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved at Least 20% Improvement in the American College of Rheumatology (ACR20) Criteria at Week 24 | Week 24 | ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant (C-reactive Protein levels \[CRP\]); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by (health assessment questionnaire disability index \[HAQ-DI\]). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR. |
| Primary | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 | Baseline, Week 12 | Physical function was assessed by HAQ-DI. It consisted of at least 2 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. Least-squares (LS) means and standard errors (SE) at Week 12 were obtained from a mixed-effect model with repeated measures (MMRM) with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI as a covariate. |
| Secondary | Change From Baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 24 | Baseline, Week 24 | DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. LS means and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline DAS28-CRP score as a covariate. |
| Secondary | Percentage of Participants Achieving ACR50 Criteria at Week 24 | Week 24 | ACR responses are assessed with a composite rating scale that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR50 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR. |
| Secondary | Percentage of Participants Achieving ACR70 Criteria at Week 24 | Week 24 | ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR. |
| Secondary | Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 24 | Week 24 | DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH by the participant assessed from the ACR rheumatoid arthritis core set questionnaire (participant global assessment) in 100 mm VAS; marker of inflammation assessed by hs-CRP in mg/L. The DAS28 provides a number indicating the current activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. |
| Secondary | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24 | Baseline, Week 24 | CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: TJC (28 joints), SJC (28 joints), Participant's Global Assessment of Disease Activity VAS (in cm), and Physician's Global Assessment of Disease VAS (in cm). Total scores ranges from 0 to 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. LS means and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline CDAI as a covariate. |
| Secondary | Change From Baseline in HAQ-DI at Week 24 | Baseline, Week 24 | Physical function was assessed by HAQ-DI. It consisted of at least 2 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. LS means and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI as a covariate. |
| Secondary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Component Summary Scores (PCS) at Week 24 | Baseline, Week 24 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: PCS and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS had 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS had 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health and well-being. LS mean and SE at Week 24 by MMRM with treatment,region,number of previous anti TNFs,visit,and treatment-by-visit interaction as fixed effects and baseline SF-36 (PCS) as a covariate. |
| Secondary | Change From Baseline in SF-36 MCS at Week 24 | Baseline, Week 24 | SF-36 is a generic 36-item questionnaire measuring HRQL covering 2 summary measures: PCS and MCS. The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health and well-being. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline SF-36 MCS as a covariate. |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved at Least 20% Improvement in the American College of Rheumatology (ACR20) Criteria at Week 24 | Week 24 | Intent-to-treat (ITT) population included all randomized participants. | percentage of participants | NUMBER |
| PRIMARY | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 | Baseline, Week 12 | ITT population. Number of participants analyzed = number of participants with HAQ-DI assessment at both baseline and Week 12. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 24 | Baseline, Week 24 | ITT population. Number of participants analyzed = number of participants with DAS28--CRP Score assessment at both baseline and Week 24. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving ACR50 Criteria at Week 24 | Week 24 | ITT population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving ACR70 Criteria at Week 24 | Week 24 | ITT population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 24 | Week 24 | ITT population. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24 | Baseline, Week 24 | ITT population. Number of participants analyzed=number of participants with CDAI assessment at both baseline and Week 24. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HAQ-DI at Week 24 | Baseline, Week 24 | ITT population. Number of participants analyzed = number of participants with HAQ-DI assessment at both baseline and Week 24. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Component Summary Scores (PCS) at Week 24 | Baseline, Week 24 | ITT population. Number of participants analyzed = participants with SF-36 PCS assessment at both baseline and Week 24. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SF-36 MCS at Week 24 | Baseline, Week 24 | ITT population. Number of participants analyzed=participants with SF-36 MCS assessment at both baseline and Week 24. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 outcomesResults by group162
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved at Least 20% Improvement in the American College of Rheumatology (ACR20) Criteria at Week 24 | Placebo q2w | 33.7 | percentage of participants | ||
| Percentage of Participants Who Achieved at Least 20% Improvement in the American College of Rheumatology (ACR20) Criteria at Week 24 | Sarilumab 150 mg q2w | 55.8 | percentage of participants | ||
| Percentage of Participants Who Achieved at Least 20% Improvement in the American College of Rheumatology (ACR20) Criteria at Week 24 | Sarilumab 200 mg q2w | 60.9 | percentage of participants | ||
| Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 | Placebo q2w | -0.26 | Standard Error 0.043 | units on a scale | |
| Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 | Sarilumab 150 mg q2w | -0.46 | Standard Error 0.044 | units on a scale | |
| Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 | Sarilumab 200 mg q2w | -0.47 | Standard Error 0.043 | units on a scale | |
| Change From Baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 24 | Placebo q2w | -1.38 | Standard Error 0.119 | units on a scale | |
| Change From Baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 24 | Sarilumab 150 mg q2w | -2.35 | Standard Error 0.111 | units on a scale | |
| Change From Baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 24 | Sarilumab 200 mg q2w | -2.82 | Standard Error 0.108 | units on a scale | |
| Percentage of Participants Achieving ACR50 Criteria at Week 24 | Placebo q2w | 18.2 | Percentage of participants |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo q2w | 181 | |
| Overall Study | STARTED | Sarilumab 150 mg q2w | 181 | |
| Overall Study | STARTED | Sarilumab 200 mg q2w | 184 | |
| Overall Study | COMPLETED | Placebo q2w | 101 | |
| Overall Study | COMPLETED | Sarilumab 150 mg q2w | 125 | |
| Overall Study | COMPLETED | Sarilumab 200 mg q2w | 133 | |
| Overall Study | NOT COMPLETED | Placebo q2w | 80 | |
| Overall Study | NOT COMPLETED | Sarilumab 150 mg q2w | 56 | |
| Overall Study | NOT COMPLETED | Sarilumab 200 mg q2w | 51 |
Source ClinicalTrials.gov
Adverse events96
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 | Nasopharyngitis | Infections and infestations | Placebo q2w | 9 | 181 | |
| other | Nasopharyngitis | Infections and infestations | Sarilumab 150 mg q2w | 11 | 181 | |
| other | Nasopharyngitis | Infections and infestations | Sarilumab 200 mg q2w | 7 | 184 | |
| other | Urinary tract infection | Infections and infestations | Placebo q2w | 12 | 181 | |
| other | Urinary tract infection | Infections and infestations | Sarilumab 150 mg q2w | 6 | 181 | |
| other | Urinary tract infection | Infections and infestations | Sarilumab 200 mg q2w | 13 | 184 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo q2w | 2 | 181 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sarilumab 150 mg q2w | 23 | 181 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sarilumab 200 mg q2w | 22 | 184 | |
| other | Hypertriglyceridaemia | Metabolism and nutrition disorders | Placebo q2w | 3 | 181 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo q2w | ||
| Total, all-cause mortality | Sarilumab 150 mg q2w | ||
| Total, all-cause mortality | Sarilumab 200 mg q2w | ||
| Total, other adverse events | Placebo q2w | 26 | 181 |
| Total, other adverse events | Sarilumab 150 mg q2w | 60 | 181 |
| Total, other adverse events | Sarilumab 200 mg q2w | 57 | 184 |
| Total, serious adverse events | Placebo q2w | 6 | 181 |
| Total, serious adverse events | Sarilumab 150 mg q2w | 6 | 181 |
| Total, serious adverse events | Sarilumab 200 mg q2w | 10 | 184 |
Source ClinicalTrials.gov
Papers10
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01709578
GET https://conductscience.org/api/trials/v1/NCT01709578/registered?page=2