Trial · NCT02057250
To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis
NCT02057250, Phase 3, Completed, Sanofi; results first posted 2017-06-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis. Trials, record NCT02057250. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02057250
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis
- NCT number
- NCT02057250
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 217 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- RA
- Interventions
- Sarilumab, Auto-Injector Device (AID), Pre-filled Syringe (PFS), Methotrexate, Sulfasalazine, Leflunomide, Hydroxychloroquine
- First posted
- 2014-02-07
- Last updated
- 2017-06-20
- Results first posted
- 2017-06-20
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Validated AID Associated Product Technical Failures (PTFs) | Baseline up to Week 12 | A PTF was defined as any product technical complaint (PTC) related to the use of the AID that had a validated technical cause. Each participant was given a diary having questions related to participant's ability to remove the cap, to start the injection, to complete the injection and regarding confirmation of completing the injection. Participants were asked to answer the questions each time they self-inject the sarilumab. If the response was "no" to any of the first 3 questions, this was considered as a PTC. The used AID, for which PTC was reported, was sent to sponsor, examined and evaluated for the occurrence of a PTF. |
| Secondary | Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab | Week 0-2: pre-dose on Day 1, anytime post-dose on Day 3, Day 5, Day 8, Day 12, Day 15; Week 10-12: pre-dose on Day 71, anytime post-dose on Day 73, Day 75, Day 78, Day 82, Day 85 | AUC(0-tau) is defined as area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval, where dose interval was 2 weeks. Serum concentrations of sarilumab were analyzed using validated enzyme linked immunosorbent assay (ELISA). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Validated AID Associated Product Technical Failures (PTFs) | Baseline up to Week 12 | Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of investigational medicinal product (IMP) with AID and attended at least 1 post-baseline visit during AID assessment phase of the study. | PTFs | NUMBER |
| SECONDARY | Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab | Week 0-2: pre-dose on Day 1, anytime post-dose on Day 3, Day 5, Day 8, Day 12, Day 15; Week 10-12: pre-dose on Day 71, anytime post-dose on Day 73, Day 75, Day 78, Day 82, Day 85 | Pharmacokinetic(PK) population included all randomized participants who received at least 1 dose of IMP and have least 1 PK parameter calculated using non compartmental methods following the first (Day 1) or sixth administration (Day 71). Here, Number Analyzed = participants with available data for specified category for each arm, respectively. | mg*day/L | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Validated AID Associated Product Technical Failures (PTFs) | Sarilumab 150 mg by AID (AID Assessment Phase) | 0 | PTFs | ||
| Number of Validated AID Associated Product Technical Failures (PTFs) | Sarilumab 200 mg by AID (AID Assessment Phase) | 0 | PTFs | ||
| Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab | Sarilumab 150 mg by AID (AID Assessment Phase) | Week 0-2 | 131 | Standard Deviation 54.5 | mg*day/L |
| Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab | Sarilumab 150 mg by PFS (AID Assessment Phase) | Week 0-2 | 152 | Standard Deviation 76.7 | mg*day/L |
| Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab | Sarilumab 200 mg by AID (AID Assessment Phase) | Week 0-2 | 235 | Standard Deviation 117 | mg*day/L |
| Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab | Sarilumab 200 mg by PFS (AID Assessment Phase) | Week 0-2 | 227 | Standard Deviation 94.9 | mg*day/L |
| Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab | Sarilumab 150 mg by AID (AID Assessment Phase) | Week 10-12 | 205 | Standard Deviation 126 | mg*day/L |
| Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab | Sarilumab 150 mg by PFS (AID Assessment Phase) | Week 10-12 | 220 | Standard Deviation 130 | mg*day/L |
| Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab | Sarilumab 200 mg by AID (AID Assessment Phase) | Week 10-12 | 455 | Standard Deviation 294 | mg*day/L |
| Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab | Sarilumab 200 mg by PFS (AID Assessment Phase) | Week 10-12 | 405 | Standard Deviation 244 | mg*day/L |
Source ClinicalTrials.gov
Participant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| AID Assessment Phase | STARTED | Sarilumab 150 mg by AID (AID Assessment Phase) | 56 | |
| AID Assessment Phase | STARTED | Sarilumab 150 mg by PFS (AID Assessment Phase) | 53 | |
| AID Assessment Phase | STARTED | Sarilumab 200 mg by AID (AID Assessment Phase) | 52 | |
| AID Assessment Phase | STARTED | Sarilumab 200 mg by PFS (AID Assessment Phase) | 56 | |
| AID Assessment Phase | STARTED | Sarilumab 150 mg by PFS (Extension Phase) | 0 | |
| AID Assessment Phase | COMPLETED | Sarilumab 150 mg by AID (AID Assessment Phase) | 52 | |
| AID Assessment Phase | COMPLETED | Sarilumab 150 mg by PFS (AID Assessment Phase) | 50 | |
| AID Assessment Phase | COMPLETED | Sarilumab 200 mg by AID (AID Assessment Phase) | 45 | |
| AID Assessment Phase | COMPLETED | Sarilumab 200 mg by PFS (AID Assessment Phase) | 54 | |
| AID Assessment Phase | COMPLETED | Sarilumab 150 mg by PFS (Extension Phase) | 0 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events225
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 | Bronchitis | Infections and infestations | Sarilumab 150 mg by AID (AID Assessment Phase) | 4 | 56 | |
| other | Bronchitis | Infections and infestations | Sarilumab 150 mg by PFS (AID Assessment Phase) | 1 | 53 | |
| other | Bronchitis | Infections and infestations | Sarilumab 200 mg by AID (AID Assessment Phase) | 1 | 52 | |
| other | Bronchitis | Infections and infestations | Sarilumab 200 mg by PFS (AID Assessment Phase) | 1 | 56 | |
| other | Bronchitis | Infections and infestations | Sarilumab 150 mg by PFS (Extension Phase) | 8 | 188 | |
| other | Nasopharyngitis | Infections and infestations | Sarilumab 150 mg by AID (AID Assessment Phase) | 4 | 56 | |
| other | Nasopharyngitis | Infections and infestations | Sarilumab 150 mg by PFS (AID Assessment Phase) | 1 | 53 | |
| other | Nasopharyngitis | Infections and infestations | Sarilumab 200 mg by AID (AID Assessment Phase) | 1 | 52 | |
| other | Nasopharyngitis | Infections and infestations | Sarilumab 200 mg by PFS (AID Assessment Phase) | 2 | 56 | |
| other | Nasopharyngitis | Infections and infestations | Sarilumab 150 mg by PFS (Extension Phase) | 4 | 188 |
1 to 10 of 225Source ClinicalTrials.gov
See all 225 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sarilumab 150 mg by AID (AID Assessment Phase) | ||
| Total, all-cause mortality | Sarilumab 150 mg by PFS (AID Assessment Phase) | ||
| Total, all-cause mortality | Sarilumab 200 mg by AID (AID Assessment Phase) | ||
| Total, all-cause mortality | Sarilumab 200 mg by PFS (AID Assessment Phase) | ||
| Total, all-cause mortality | Sarilumab 150 mg by PFS (Extension Phase) | ||
| Total, other adverse events | Sarilumab 150 mg by AID (AID Assessment Phase) | 29 | 56 |
| Total, other adverse events | Sarilumab 150 mg by PFS (AID Assessment Phase) | 21 | 53 |
| Total, other adverse events | Sarilumab 200 mg by AID (AID Assessment Phase) | 24 | 52 |
| Total, other adverse events | Sarilumab 200 mg by PFS (AID Assessment Phase) | 23 | 56 |
| Total, other adverse events | Sarilumab 150 mg by PFS (Extension Phase) | 83 | 188 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29209946 | DERIVED |
Source PubMed
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/NCT02057250
GET https://conductscience.org/api/trials/v1/NCT02057250/flow?page=2