Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients
Public ClinicalTrials.gov record NCT01061736. 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, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Part B (pivotal study): To demonstrate that sarilumab added to MTX was effective in: * reduction of signs and symptoms of rheumatoid arthritis at 24 weeks * inhibition of progression of structural damage at 52 weeks * improvement in physical function at 16 weeks Secondary Objectives: Part B: To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks To assess the safety of sarilumab added to MTX To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.
Study identification
- NCT ID
- NCT01061736
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 1,675 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- 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
- Mar 2010 (Type not available)
- Primary completion
- Oct 2013 (Actual)
- Completion
- Oct 2013 (Actual)
- Last update posted
- Jun 28, 2017
2010 – 2013
United States locations
- U.S. sites
- 45
- U.S. states
- 20
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840070 | Anniston | Alabama | 36207 | — |
| Investigational Site Number 840004 | Birmingham | Alabama | 35205 | — |
| Investigational Site Number 840072 | Gilbert | Arizona | 85234 | — |
| Investigational Site Number 840029 | Beverly Hills | California | 90211 | — |
| Investigational Site Number 840007 | Palm Desert | California | 92260 | — |
| Investigational Site Number 840008 | San Francisco | California | 94143 | — |
| Investigational Site Number 840021 | Santa Maria | California | 94354 | — |
| Investigational Site Number 840049 | Upland | California | 91786 | — |
| Investigational Site Number 840050 | Dunedin | Florida | 34698 | — |
| Investigational Site Number 840041 | Jacksonville | Florida | 32209 | — |
| Investigational Site Number 840067 | Jupiter | Florida | 33458 | — |
| Investigational Site Number 840048 | Miami | Florida | 33155 | — |
| Investigational Site Number 840006 | Orlando | Florida | 32806 | — |
| Investigational Site Number 840063 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 840060 | Sarasota | Florida | 34239 | — |
| Investigational Site Number 840003 | Atlanta | Georgia | 30322 | — |
| Investigational Site Number 840028 | Decatur | Georgia | 30033 | — |
| Investigational Site Number 840027 | Marietta | Georgia | 30060 | — |
| Investigational Site Number 840018 | Idaho Falls | Idaho | 83404 | — |
| Investigational Site Number 840046 | Chicago | Illinois | 60612 | — |
| Investigational Site Number 840015 | Lexington | Kentucky | 40504 | — |
| Investigational Site Number 840073 | Cumberland | Maryland | 21502 | — |
| Investigational Site Number 840055 | Frederick | Maryland | 21702 | — |
| Investigational Site Number 840013 | Wheaton | Maryland | 20902 | — |
| Investigational Site Number 840066 | St Louis | Missouri | 63117 | — |
| Investigational Site Number 840071 | Omaha | Nebraska | 68114 | — |
| Investigational Site Number 840056 | New York | New York | 10016 | — |
| Investigational Site Number 840068 | Hickory | North Carolina | 28601 | — |
| Investigational Site Number 840044 | Toledo | Ohio | 43606 | — |
| Investigational Site Number 840002 | Oklahoma City | Oklahoma | 73103 | — |
| Investigational Site Number 840011 | Tulsa | Oklahoma | 74104 | — |
| Investigational Site Number 840065 | Tulsa | Oklahoma | 74135 | — |
| Investigational Site Number 840010 | Bethlehem | Pennsylvania | 18015 | — |
| Investigational Site Number 840009 | Duncansville | Pennsylvania | 16635 | — |
| Investigational Site Number 840062 | Reading | Pennsylvania | 19611 | — |
| Investigational Site Number 840058 | Columbia | South Carolina | 29204 | — |
| Investigational Site Number 840016 | North Charleston | South Carolina | 29406 | — |
| Investigational Site Number 840025 | Jackson | Tennessee | 38305 | — |
| Investigational Site Number 840001 | Dallas | Texas | 75231 | — |
| Investigational Site Number 840022 | Dallas | Texas | 75235 | — |
| Investigational Site Number 840012 | Dallas | Texas | 75390 | — |
| Investigational Site Number 840020 | Houston | Texas | 77034 | — |
| Investigational Site Number 840069 | Lubbock | Texas | 79424 | — |
| Investigational Site Number 840074 | Mesquite | Texas | 75150 | — |
| Investigational Site Number 840061 | Tacoma | Washington | 98405 | — |
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 217 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01061736, 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 Jun 28, 2017 · Synced Oct 22, 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 NCT01061736 live on ClinicalTrials.gov.