Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Regeneron Pharmaceuticals
- Study ID
- NCT02097524
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Sarilumab — DRUG
- Tocilizumab — DRUG
Study Details
The main purposes of this study are to describe the pharmacodynamic effects, safety and pharmacokinetics of a single dose of sarilumab.
Key Dates
- Start date
- Mar 31, 2014
- Status verified
- May 2015
- Primary completion
- Apr 30, 2015
- Completion
- Apr 30, 2015
Study Design
- Enrollment
- 105 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Sarilumab - dose 1Single subcutaneous (SC) injection of Sarilumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
- Experimental: Sarilumab - dose 2Single SC injection of Sarilumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
- Active Comparator: Tocilizumab - dose 1Single intravenous (IV) administration of Tocilizumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
- Active Comparator: Tocilizumab - dose 2Single IV administration of Tocilizumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Primary Outcome Measure
PD parameters [ Time Frame: baseline through week 4 ]
Locations (19)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Birmingham | Alabama | - | - |
| - | Orange | California | - | - |
| - | DeLand | Florida | - | - |
| - | Edgewater | Florida | - | - |
| - | Miami | Florida | - | - |
| - | Miami Lakes | Florida | - | - |
| - | Granger | Indiana | - | - |
| - | Grand Blanc | Michigan | - | - |
| - | Charlotte | North Carolina | - | - |
| - | Cinicinnati | Ohio | - | - |
| - | Memphis | Tennessee | - | - |
| - | Austin | Texas | - | - |
| - | Carrollton | Texas | - | - |
| - | Channelview | Texas | - | - |
| - | Dallas | Texas | - | - |
| - | Houston | Texas | - | - |
| - | Mesquite | Texas | - | - |
| - | Plano | Texas | - | - |
| - | San Antonio | Texas | - | - |
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