Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)
1 other identifier
interventional
105
1 country
19
Brief Summary
The main purposes of this study are to describe the pharmacodynamic effects, safety and pharmacokinetics of a single dose of sarilumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 rheumatoid-arthritis
Started Mar 2014
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 3, 2014
CompletedFirst Posted
Study publicly available on registry
March 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 5, 2015
May 1, 2015
1.1 years
March 3, 2014
May 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
PD parameters
Pharmacodynamic (PD) parameters, what a drug does to the body, will be collected from baseline through week 4: * the time to nadir (or peak) * change from baseline * area under the curve (AUC)
baseline through week 4
Secondary Outcomes (2)
Percentage of TEAEs
baseline through week 6
PK parameters
baseline through week 4
Study Arms (4)
Sarilumab - dose 1
EXPERIMENTALSingle subcutaneous (SC) injection of Sarilumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Sarilumab - dose 2
EXPERIMENTALSingle SC injection of Sarilumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Tocilizumab - dose 1
ACTIVE COMPARATORSingle intravenous (IV) administration of Tocilizumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Tocilizumab - dose 2
ACTIVE COMPARATORSingle IV administration of Tocilizumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Interventions
Eligibility Criteria
You may qualify if:
- Patients with RA as defined by the 2010 revised American College of Rheumatology (ACR)
- ACR Class I-III functional status, based on the 1991 revised criteria
- Treated for a minimum of 12 weeks with Methotrexate with a stable dose of MTX for at least 8 weeks prior to screening visit
You may not qualify if:
- Patients less than 18 years of age or minimum legal age
- Prior treatment with any biologic anti-Interleukin 6 (IL-6) or IL-6 Receptor (IL-6R) antagonists
- Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening
- Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks prior to randomization
- Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening visit, whichever is longer
- Treatment with oral/ biologic DMARDs (disease-modifying antirheumatic drugs), other than MTX, within a certain amount of time prior to screening visit
- Active or suspected TB or at high risk of contracting TB
- Fever, or chronic, persistent, or recurring infections requiring active treatment
- HIV positive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Sanoficollaborator
Study Sites (19)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Orange, California, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Edgewater, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Miami Lakes, Florida, United States
Unknown Facility
Granger, Indiana, United States
Unknown Facility
Grand Blanc, Michigan, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Cinicinnati, Ohio, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Carrollton, Texas, United States
Unknown Facility
Channelview, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Mesquite, Texas, United States
Unknown Facility
Plano, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Related Publications (2)
Kovalenko P, Paccaly A, Boyapati A, Xu C, St John G, Nivens MC, Davis JD, Rippley R, DiCioccio AT. Population Pharmacodynamic Model of Neutrophil Margination and Tolerance to Describe Effect of Sarilumab on Absolute Neutrophil Count in Patients with Rheumatoid Arthritis. CPT Pharmacometrics Syst Pharmacol. 2020 Jul;9(7):405-416. doi: 10.1002/psp4.12534. Epub 2020 Jun 20.
PMID: 32453485DERIVEDEmery P, Rondon J, Parrino J, Lin Y, Pena-Rossi C, van Hoogstraten H, Graham NMH, Liu N, Paccaly A, Wu R, Spindler A. Safety and tolerability of subcutaneous sarilumab and intravenous tocilizumab in patients with rheumatoid arthritis. Rheumatology (Oxford). 2019 May 1;58(5):849-858. doi: 10.1093/rheumatology/key361.
PMID: 30590833DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2014
First Posted
March 27, 2014
Study Start
March 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
May 5, 2015
Record last verified: 2015-05