To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis (SARIL-RA-EASY)
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ClinicalTrials.gov Identifier: NCT02057250 |
Recruitment Status :
Completed
First Posted : February 7, 2014
Results First Posted : June 20, 2017
Last Update Posted : June 20, 2017
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Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
RA |
Interventions |
Drug: Sarilumab Device: Auto-Injector Device (AID) Device: Pre-filled Syringe (PFS) Drug: Methotrexate Drug: Sulfasalazine Drug: Leflunomide Drug: Hydroxychloroquine |
Enrollment | 217 |
Participant Flow
Recruitment Details | The study was conducted at 53 centers in 6 countries. A total of 419 participants were screened between 18 March 2014 and 14 October 2014, out of which 217 participants were enrolled and treated. |
Pre-assignment Details | Participants were randomized in 1:1:1:1 ratio to Sarilumab 150 mg administered by auto-injector device (AID) or prefilled syringe (PFS) or Sarilumab 200 mg administered by AID or PFS. Participants who completed 12-week AID assessment phase, were treated in open-label extension phase for 52 weeks. |
Arm/Group Title | Sarilumab 150 mg by AID (AID Assessment Phase) | Sarilumab 150 mg by PFS (AID Assessment Phase) | Sarilumab 200 mg by AID (AID Assessment Phase) | Sarilumab 200 mg by PFS (AID Assessment Phase) | Sarilumab 150 mg by PFS (Extension Phase) |
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Sarilumab 150 mg subcutaneous (SC) injection every 2 weeks (q2w) administered by AID with one or a combination of non-biologic disease-modifying anti-rheumatic drug (DMARD) for 12 weeks. | Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks. | Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks. | Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks. | Participants who completed 12 week AID assessment phase received Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. |
Period Title: AID Assessment Phase | |||||
Started | 56 | 53 | 52 | 56 | 0 |
Completed | 52 | 50 | 45 | 54 | 0 |
Not Completed | 4 | 3 | 7 | 2 | 0 |
Reason Not Completed | |||||
Adverse Event | 3 | 2 | 6 | 1 | 0 |
Other than specified above | 1 | 1 | 1 | 1 | 0 |
Period Title: Extension Phase | |||||
Started | 0 | 0 | 0 | 0 | 192 [1] |
Treated | 0 | 0 | 0 | 0 | 188 |
Completed | 0 | 0 | 0 | 0 | 156 |
Not Completed | 0 | 0 | 0 | 0 | 36 |
Reason Not Completed | |||||
Adverse Event | 0 | 0 | 0 | 0 | 15 |
Lack of Efficacy | 0 | 0 | 0 | 0 | 10 |
Entered in this period but not treated | 0 | 0 | 0 | 0 | 4 |
Other than specified above | 0 | 0 | 0 | 0 | 7 |
[1]
9 participants who completed AID Assessment phase did not enter extension phase.
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Baseline Characteristics
Arm/Group Title | Sarilumab 150 mg by AID (AID Assessment Phase) | Sarilumab 150 mg by PFS (AID Assessment Phase) | Sarilumab 200 mg by AID (AID Assessment Phase) | Sarilumab 200 mg by PFS (AID Assessment Phase) | Total | |
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Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks. | Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks. | Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks. | Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 56 | 53 | 52 | 56 | 217 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 56 participants | 53 participants | 52 participants | 56 participants | 217 participants | |
53.7 (13.8) | 54.2 (14.2) | 55.9 (12.3) | 50.3 (12.8) | 53.5 (13.4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 56 participants | 53 participants | 52 participants | 56 participants | 217 participants | |
Female |
45 80.4%
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43 81.1%
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44 84.6%
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49 87.5%
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181 83.4%
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Male |
11 19.6%
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10 18.9%
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8 15.4%
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7 12.5%
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36 16.6%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: | Trial Transparency Team |
Organization: | Sanofi |
EMail: | Contact-US@sanofi.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT02057250 |
Other Study ID Numbers: |
MSC12665 2012-004339-21 U1111-1130-9931 ( Other Identifier: UTN ) |
First Submitted: | January 31, 2014 |
First Posted: | February 7, 2014 |
Results First Submitted: | May 23, 2017 |
Results First Posted: | June 20, 2017 |
Last Update Posted: | June 20, 2017 |