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)
Public ClinicalTrials.gov record NCT01709578. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-α Antagonists
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) were effective for: * reduction of signs and symptoms at Week 24 and * improvement of physical function at Week 12 in participants with active rheumatoid arthritis (RA) who were inadequate responders or intolerant to tumor necrosis factor alpha (TNF-α) antagonists. Secondary Objectives: The secondary objectives were to investigate the effects of SAR153191 (REGN88) when added to DMARD therapy, in participants with active RA who were inadequate responders or intolerant to TNF-α antagonists, for: * Reduction of signs and symptoms at Week 12; * Improvement in physical function at Week 24; * Improvement in disease activity score as measured by other American College of Rheumatology (ACR) derived components at Weeks 12 and 24; * Improvement in quality of life as measured by participant reported outcomes (PROs) at intermediate visits and Week 24. To assess the exposure of sarilumab added to DMARD therapy in this population. To assess the safety of sarilumab in this population.
Study identification
- NCT ID
- NCT01709578
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 546 participants
Conditions and interventions
Conditions
Interventions
- Sarilumab Drug
- placebo Drug
- hydroxychloroquine Drug
- methotrexate Drug
- sulfasalazine Drug
- leflunomide Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2012 (Type not available)
- Primary completion
- Mar 2015 (Actual)
- Completion
- Mar 2015 (Actual)
- Last update posted
- Aug 8, 2017
2012 – 2015
United States locations
- U.S. sites
- 56
- U.S. states
- 23
- U.S. cities
- 55
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840070 | Anniston | Alabama | 36207 | — |
| Investigational Site Number 840138 | Birmingham | Alabama | 35205 | — |
| Investigational Site Number 840142 | Phoenix | Arizona | 85037 | — |
| Investigational Site Number 840134 | Fullerton | California | 92835 | — |
| Investigational Site Number 840141 | Glendale | California | 85304 | — |
| Investigational Site Number 840111 | La Jolla | California | 92037 | — |
| Investigational Site Number 840135 | San Diego | California | 92120 | — |
| Investigational Site Number 840021 | Santa Maria | California | 94354 | — |
| Investigational Site Number 840100 | Stanford | California | 94305 | — |
| Investigational Site Number 840049 | Upland | California | 91786 | — |
| Investigational Site Number 840131 | Whittier | California | 90606 | — |
| Investigational Site Number 840201 | Denver | Colorado | 80230 | — |
| Investigational Site Number 840130 | Lewes | Delaware | 19958 | — |
| Investigational Site Number 840125 | DeBary | Florida | 32713 | — |
| Investigational Site Number 840048 | Miami | Florida | 33155 | — |
| Investigational Site Number 840024 | Naples | Florida | 34102 | — |
| Investigational Site Number 840006 | Orlando | Florida | 32806 | — |
| Investigational Site Number 840128 | Ormond Beach | Florida | 32174 | — |
| Investigational Site Number 840063 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 840060 | Sarasota | Florida | 34239 | — |
| Investigational Site Number 840140 | Tampa | Florida | 33614 | — |
| Investigational Site Number 840126 | Vero Beach | Florida | 32960 | — |
| Investigational Site Number 840018 | Idaho Falls | Idaho | 83404 | — |
| Investigational Site Number 840110 | Meridian | Idaho | 83642 | — |
| Investigational Site Number 840052 | Kansas City | Kansas | 66160-7321 | — |
| Investigational Site Number 840015 | Lexington | Kentucky | 40504 | — |
| Investigational Site Number 840120 | Baton Rouge | Louisiana | 70809 | — |
| Investigational Site Number 840109 | Lake Charles | Louisiana | 70601 | — |
| Investigational Site Number 840055 | Frederick | Maryland | 21702 | — |
| Investigational Site Number 840150 | Lansing | Michigan | 48910 | — |
| Investigational Site Number 840137 | Saint Clair Shores | Michigan | 48081 | — |
| Investigational Site Number 840037 | Tupelo | Mississippi | 38801 | — |
| Investigational Site Number 840112 | Lincoln | Nebraska | 68516 | — |
| Investigational Site Number 840106 | Orchard Park | New York | 14127 | — |
| Investigational Site Number 840121 | Rochester | New York | 14609 | — |
| Investigational Site Number 840115 | Roslyn | New York | 11576 | — |
| Investigational Site Number 840118 | Smithtown | New York | 11787 | — |
| Investigational Site Number 840139 | Syracuse | New York | 13210 | — |
| Investigational Site Number 840123 | Charlotte | North Carolina | 28210 | — |
| Investigational Site Number 840116 | Wilmington | North Carolina | 28401 | — |
| Investigational Site Number 840127 | Oklahoma City | Oklahoma | 73103 | — |
| Investigational Site Number 840011 | Tulsa | Oklahoma | 74104 | — |
| Investigational Site Number 840009 | Duncansville | Pennsylvania | 16635 | — |
| Investigational Site Number 840117 | Pittsburgh | Pennsylvania | 15213 | — |
| Investigational Site Number 840062 | Reading | Pennsylvania | 19611 | — |
| Investigational Site Number 840058 | Columbia | South Carolina | 29204 | — |
| Investigational Site Number 840025 | Jackson | Tennessee | 38305 | — |
| Investigational Site Number 840059 | Memphis | Tennessee | 38119 | — |
| Investigational Site Number 840132 | Austin | Texas | 78731 | — |
| Investigational Site Number 840022 | Dallas | Texas | 75235 | — |
| Investigational Site Number 840114 | El Paso | Texas | 79902 | — |
| Investigational Site Number 840133 | Houston | Texas | 77008 | — |
| Investigational Site Number 840129 | Houston | Texas | 77074 | — |
| Investigational Site Number 840074 | Mesquite | Texas | 75150 | — |
| Investigational Site Number 840036 | Spokane | Washington | 99204 | — |
| Investigational Site Number 840124 | Clarksburg | West Virginia | 26301 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 140 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01709578, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 8, 2017 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01709578 live on ClinicalTrials.gov.