Trial record 1 of 1 for:
SARIL-RA-ASCERTAIN
To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01768572 |
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Recruitment Status :
Completed
First Posted : January 15, 2013
Results First Posted : June 26, 2017
Last Update Posted : June 26, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Rheumatoid Arthritis |
| Interventions |
Drug: sarilumab SAR153191 (REGN88) Drug: tocilizumab Drug: hydroxychloroquine Drug: methotrexate Drug: sulfasalazine Drug: leflunomide Drug: subcutaneous placebo Drug: intravenous placebo |
| Enrollment | 202 |
Participant Flow
| Recruitment Details | The study was conducted at 78 centers in 19 countries. A total of 389 participants were screened between 25 March 2013 and 02 April 2014, 187 of whom were screen failures. Screen failures were mainly due to failure to meet inclusion and exclusion criteria. |
| Pre-assignment Details | Randomization of participants were stratified by region and screening value of absolute neutrophil count. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in 1:1:2 (sarilumab 150 mg q2w: sarilumab 200 mg q2w: tocilizumab q4w). 202 participants were randomized. |
| Arm/Group Title | Sarilumab 150 mg q2w | Sarilumab 200 mg q2w | Tocilizumab q4w |
|---|---|---|---|
 Arm/Group Description |
Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD) for 24 weeks. | Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks. | Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator's discretion. |
| Period Title: Overall Study | |||
| Started | 49 | 51 | 102 |
| Completed | 40 | 39 | 96 |
| Not Completed | 9 | 12 | 6 |
| Reason Not Completed | |||
| Adverse Event | 7 | 8 | 4 |
| Lack of Efficacy | 1 | 3 | 1 |
| Other, Not due to an adverse event | 1 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Sarilumab 150 mg q2w | Sarilumab 200 mg q2w | Tocilizumab q4w | Total | |
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Arm/Group Description |
Sarilumab 150 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks. | Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks. | Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator's discretion. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 49 | 51 | 102 | 202 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 49 participants | 51 participants | 102 participants | 202 participants | |
| 54.8 (12.1) | 51.7 (13.1) | 50.4 (13.0) | 51.8 (12.8) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 49 participants | 51 participants | 102 participants | 202 participants | |
| Female |
41 83.7%
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39 76.5%
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82 80.4%
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162 80.2%
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| Male |
8 16.3%
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12 23.5%
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20 19.6%
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40 19.8%
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Duration of rheumatoid arthritis (RA) since diagnosis
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 49 participants | 51 participants | 102 participants | 202 participants | |
| 13.59 (8.24) | 10.45 (7.57) | 10.84 (8.91) | 11.41 (8.48) | ||
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RA functional class
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 49 participants | 51 participants | 102 participants | 202 participants |
| I | 10 | 4 | 16 | 30 | |
| II | 25 | 33 | 62 | 120 | |
| III | 14 | 14 | 24 | 52 | |
| IV | 0 | 0 | 0 | 0 | |
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[1]
Measure Description: RA Class I participants: completely able to perform usual activities of daily living (self-care, vocational and avocational); Class II participants: able to perform usual self-care and vocational activities, but limited in avocational activities; Class III participants: able to perform usual self-care activities, but limited in vocational and avocational activities; Class IV participants: limited in ability to perform usual self-care, vocational and avocational activities.
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Health Assessment Questionnaire Disability Index (HAQ-DI)
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 49 participants | 51 participants | 102 participants | 202 participants | |
| 1.63 (0.66) | 1.71 (0.60) | 1.78 (0.63) | 1.72 (0.63) | ||
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[1]
Measure Description: Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: HAQ-DI is consisted of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; activities are rated on a 4-point scale where 0=best and 3=worst. Overall score was computed as the sum of domain scores and divided by the number of domains answered, ranging from 0 to 3, where 0 = no disability and 3 = very severe, high-dependency disability.
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Disease Activity Score for 28 Joints- C-reactive protein (DAS28-CRP)
[1] Mean (Standard Deviation) Unit of measure: Score on scale |
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| Number Analyzed | 49 participants | 51 participants | 102 participants | 202 participants | |
| 5.85 (0.92) | 5.88 (0.97) | 5.91 (1.01) | 5.89 (0.97) | ||
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[1]
Measure Description: The DAS28-CRP is a composite score that contains 4 variables: Tender Joints Count (based on 28 joints), Swollen Joints Count (based on 28 joints), general health assessment and high sensitivity C-reactive protein (hs-CRP) in mg/L or erythrocyte sedimentation rate (ESR) in mm/hr. It ranges from 0-10 with a lower score indicating less disease activity. A DAS28-CRP above 5.1 indicates high disease activity, whereas a below 3.2 indicates low disease activity and below 2.6 as disease remission.
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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: | NCT01768572 |
| Other Study ID Numbers: |
SFY13370 2012-003536-23 U1111-1133-7839 ( Other Identifier: UTN ) |
| First Submitted: | January 11, 2013 |
| First Posted: | January 15, 2013 |
| Results First Submitted: | May 23, 2017 |
| Results First Posted: | June 26, 2017 |
| Last Update Posted: | June 26, 2017 |