Trial · NCT01061736
Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients
NCT01061736, Phase 2, Phase 3, Completed, Sanofi; results first posted 2017-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients. Trials, record NCT01061736. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01061736
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients
- NCT number
- NCT01061736
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,675 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Rheumatoid Arthritis
- Interventions
- Sarilumab, Placebo (for sarilumab), Methotrexate, Folic Acid
- First posted
- 2010-02-03
- Last updated
- 2017-06-28
- Other registries' IDs
- eudract:2009-016266-90
- Results first posted
- 2017-06-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 | Baseline to Week 12 | ACR20 response was defined, based on guidelines set forth by the American College of Rheumatology (ACR), as ≥20 % improvement in tender joint count and swollen joint count as well as ≥20% improvement in at least 3 of 5 following measures: C-Reactive Protein (CRP), Participant assessment of pain; Participant's global assessment of disease activity; Physician global assessment of disease activity; and Health Assessment Question-Disability Index (HAQ-DI). Missing data imputed by Last Observation Carried Forward (LOCF). |
| Primary | Part B: Percentage of Participants Achieving ACR20 Response at Week 24 | Baseline to Week 24 | ACR20 improvement responses were determined without imputation of missing post-baseline values. In addition data collected after treatment discontinuation or rescue was set to missing. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment. |
| Primary | Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16 | Baseline, Week 16 | HAQ-DI was a participant-reported questionnaire that assesses the difficulty of performing daily activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Overall score range from 0=least difficulty to 3=extreme difficulty. An increase in the score indicates a worsening of physical function while a decrease in the score represents improvement. Data collected after treatment discontinuation was set to missing. |
| Primary | Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52 | Baseline, Week 52 | The Sharp method modified by D. van der Heijde involves separate scores for erosions and joint space narrowing based on radiographs to assess the degree of structural damage. Total score range from 0 (normal) to 448 (worst possible total score). An increase in total score represents progression of structural damage. Missing data were imputed by the linear extrapolation method. |
| Secondary | Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52 | Baseline up to Week 52 | Major clinical response was defined as an ACR70 response maintained for at least 24 consecutive weeks. ACR70 response uses the same criteria as for ACR20 but requires 70% improvement. In the primary approach, data collected after treatment discontinuation or rescue was set to missing. No imputation of missing post-baseline values was performed. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 | Baseline to Week 12 | Part A Intent-to-treat (ITT) population defined as all randomized participants. | Percentage of participants | NUMBER |
| PRIMARY | Part B: Percentage of Participants Achieving ACR20 Response at Week 24 | Baseline to Week 24 | ITT population which included all participants randomized after dose selection (cohort 2). | Percentage of participants | NUMBER |
| PRIMARY | Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16 | Baseline, Week 16 | Cohort 2 ITT population only and included participants with available data of HAQ-DI at baseline and on or before Week 16. | units on a scale | MEAN |
| PRIMARY | Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52 | Baseline, Week 52 | Cohort 2 ITT population and included participants with available data of mTSS at baseline and on or before Week 52. | units on a scale | MEAN |
| SECONDARY | Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52 | Baseline up to Week 52 | ITT population which included all participants randomized after dose selection (cohort 2). | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 | Part A: SAR 100 mg qw | 62 | Percentage of participants | ||
| Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 | Part A: SAR 150 mg qw | 72 | Percentage of participants | ||
| Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 | Part A: SAR 100 mg q2w | 49 | Percentage of participants | ||
| Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 | Part A: SAR 150 mg q2w | 66.7 | Percentage of participants | ||
| Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 | Part A: SAR 200 mg q2w | 65.4 | Percentage of participants | ||
| Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 | Part A: Placebo qw | 46.2 | Percentage of participants | ||
| Part B: Percentage of Participants Achieving ACR20 Response at Week 24 | Part B: SAR 150 mg q2w | 58 | Percentage of participants | ||
| Part B: Percentage of Participants Achieving ACR20 Response at Week 24 | Part B: SAR 200 mg q2w | 66.4 | Percentage of participants | ||
| Part B: Percentage of Participants Achieving ACR20 Response at Week 24 | Part B: Placebo q2w | 33.4 | Percentage of participants | ||
| Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16 | Part B: SAR 150 mg q2w | Baseline | 1.63 | Standard Deviation 0.63 | units on a scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow50
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: SAR 100 mg qw | 50 | |
| Overall Study | STARTED | Part A: SAR 150 mg qw | 50 | |
| Overall Study | STARTED | Part A: SAR 100 mg q2w | 51 | |
| Overall Study | STARTED | Part A: SAR 150 mg q2w | 51 | |
| Overall Study | STARTED | Part A: SAR 200 mg q2w | 52 | |
| Overall Study | STARTED | Part A: Placebo qw | 52 | |
| Overall Study | STARTED | Part B Cohort 1: Non-selected Doses | 84 | |
| Overall Study | STARTED | Part B: SAR 150 mg q2w (Cohort 1 [Selected Dose]+Cohort 2) | 430 | |
| Overall Study | STARTED | Part B: SAR 200 mg q2w (Cohort 1 [Selected Dose]+Cohort 2) | 427 | |
| Overall Study | STARTED | Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2) | 428 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 participant flowAdverse events1,846
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 | Neutropenia | Blood and lymphatic system disorders | Part A: SAR 100 mg qw | 6 | 50 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part A: SAR 150 mg qw | 5 | 50 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part A: SAR 100 mg q2w | 0 | 51 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part A: SAR 150 mg q2w | 1 | 52 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part A: SAR 200 mg q2w | 10 | 51 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part A: Placebo qw | 0 | 51 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part B: SAR 100 mg qw Cohort 1 (Non-selected Dose) | 1 | 29 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part B: SAR 150 mg qw Cohort 1 (Non-selected Dose) | 2 | 26 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part B: SAR 100 mg q2w Cohort 1 (Non-selected Dose) | 1 | 29 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2) | 36 | 370 |
1 to 10 of 1,846Source ClinicalTrials.gov
See all 1,846 adverse eventsAdverse event totals39
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: SAR 100 mg qw | ||
| Total, all-cause mortality | Part A: SAR 150 mg qw | ||
| Total, all-cause mortality | Part A: SAR 100 mg q2w | ||
| Total, all-cause mortality | Part A: SAR 150 mg q2w | ||
| Total, all-cause mortality | Part A: SAR 200 mg q2w | ||
| Total, all-cause mortality | Part A: Placebo qw | ||
| Total, all-cause mortality | Part B: SAR 100 mg qw Cohort 1 (Non-selected Dose) | ||
| Total, all-cause mortality | Part B: SAR 150 mg qw Cohort 1 (Non-selected Dose) | ||
| Total, all-cause mortality | Part B: SAR 100 mg q2w Cohort 1 (Non-selected Dose) | ||
| Total, all-cause mortality | Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2) |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse event totalsPapers12
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/NCT01061736
GET https://conductscience.org/api/trials/v1/NCT01061736/results?page=2