Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)
NCT ID: NCT02097524
Last Updated: 2015-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
105 participants
INTERVENTIONAL
2014-03-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Sarilumab - dose 1
Single subcutaneous (SC) injection of Sarilumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Sarilumab
Sarilumab - dose 2
Single SC injection of Sarilumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Sarilumab
Tocilizumab - dose 1
Single intravenous (IV) administration of Tocilizumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Tocilizumab
Tocilizumab - dose 2
Single IV administration of Tocilizumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Tocilizumab
Interventions
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Sarilumab
Tocilizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ACR Class I-III functional status, based on the 1991 revised criteria
3. Treated for a minimum of 12 weeks with Methotrexate with a stable dose of MTX for at least 8 weeks prior to screening visit
Exclusion Criteria
2. Prior treatment with any biologic anti-Interleukin 6 (IL-6) or IL-6 Receptor (IL-6R) antagonists
3. Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening
4. 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
5. 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
6. Treatment with oral/ biologic DMARDs (disease-modifying antirheumatic drugs), other than MTX, within a certain amount of time prior to screening visit
7. Active or suspected TB or at high risk of contracting TB
8. Fever, or chronic, persistent, or recurring infections requiring active treatment
9. HIV positive
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Birmingham, Alabama, United States
Orange, California, United States
DeLand, Florida, United States
Edgewater, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Granger, Indiana, United States
Grand Blanc, Michigan, United States
Charlotte, North Carolina, United States
Cinicinnati, Ohio, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Carrollton, Texas, United States
Channelview, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Mesquite, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Countries
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References
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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.
Emery 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.
Other Identifiers
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6R88-RA-1309
Identifier Type: -
Identifier Source: org_study_id
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