Sarilumab

Generic Name
Sarilumab
Brand Names
Kevzara
Drug Type
Biotech
Chemical Formula
-
CAS Number
1189541-98-7
Unique Ingredient Identifier
NU90V55F8I
Background

Sarilumab is a fully human anti-interleukin 6 (IL-6) receptor monoclonal IgG1 antibody that binds to both membrane-bound and soluble IL-6 receptor forms, thus blocking the cis- and trans-inflammatory signalling cascades of IL-6. Sarilumab was developed by Sanofi and Regeneron Pharmaceuticals, Inc; it was US FDA-approved in May 2017 and followed by EU approva...

Indication

Sarilumab is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs); and adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tole...

Associated Conditions
Polymyalgia Rheumatica (PMR), Moderate, active Rheumatoid arthritis, Severe, active Rheumatoid arthritis
Associated Therapies
-

Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)

First Posted Date
2015-01-07
Last Posted Date
2022-03-28
Lead Sponsor
Sanofi
Target Recruit Count
369
Registration Number
NCT02332590
Locations
🇺🇸

Investigational Site Number 840403, Saint Petersburg, Florida, United States

🇺🇸

Investigational Site Number 840229, Coral Gables, Florida, United States

🇺🇸

Investigational Site Number 840140, Tampa, Florida, United States

and more 83 locations

Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-03-27
Last Posted Date
2015-05-05
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
105
Registration Number
NCT02097524

To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

First Posted Date
2014-02-07
Last Posted Date
2017-06-20
Lead Sponsor
Sanofi
Target Recruit Count
217
Registration Number
NCT02057250
Locations
🇨🇱

Investigational Site Number 152050, Santiago, Chile

🇨🇱

Investigational Site Number 152007, Viña Del Mar, Chile

🇲🇽

Investigational Site Number 484005, Monterrey, Mexico

and more 50 locations

Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis

First Posted Date
2013-07-16
Last Posted Date
2017-06-20
Lead Sponsor
Sanofi
Target Recruit Count
58
Registration Number
NCT01900431
Locations
🇺🇸

Investigational Site Number 840007, Cleveland, Ohio, United States

🇹🇷

Investigational Site Number 792004, Izmir, Turkey

🇹🇷

Investigational Site Number 792006, Izmir, Turkey

and more 17 locations

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

First Posted Date
2013-01-10
Last Posted Date
2017-07-27
Lead Sponsor
Sanofi
Target Recruit Count
776
Registration Number
NCT01764997
Locations
🇺🇸

Investigational Site Number 840203, Washington, D.C., District of Columbia, United States

🇦🇷

Investigational Site Number 032009, Zarate, Argentina

🇨🇱

Investigational Site Number 152018, Santiago, Chile

and more 254 locations

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)

First Posted Date
2012-10-18
Last Posted Date
2017-08-08
Lead Sponsor
Sanofi
Target Recruit Count
546
Registration Number
NCT01709578
Locations
🇺🇸

Investigational Site Number 840018, Idaho Falls, Idaho, United States

🇺🇸

Investigational Site Number 840058, Columbia, South Carolina, United States

🇺🇸

Investigational Site Number 840124, Clarksburg, West Virginia, United States

and more 193 locations

Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers

First Posted Date
2010-10-08
Last Posted Date
2017-09-01
Lead Sponsor
Sanofi
Target Recruit Count
16
Registration Number
NCT01217814
Locations
🇲🇽

Investigational Site Number 484008, Durango, Mexico

🇨🇴

Investigational Site Number 170004, Barranquilla, Colombia

🇨🇴

Investigational Site Number 170005, Barranquilla, Colombia

and more 11 locations

Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2010-05-07
Last Posted Date
2017-06-21
Lead Sponsor
Sanofi
Target Recruit Count
223
Registration Number
NCT01118728
Locations
🇪🇸

Sanofi-Aventis Administrative Office, Barcelona, Spain

Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients

First Posted Date
2010-02-03
Last Posted Date
2017-06-28
Lead Sponsor
Sanofi
Target Recruit Count
1675
Registration Number
NCT01061736
Locations
🇦🇷

Investigational Site Number 032002, Cordoba, Argentina

🇦🇷

Investigational Site Number 032004, Tucuman, Argentina

🇦🇷

Investigational Site Number 032003, Córdoba, Argentina

and more 259 locations

Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-02-03
Last Posted Date
2017-08-08
Lead Sponsor
Sanofi
Target Recruit Count
301
Registration Number
NCT01061723
Locations
🇺🇸

Investigational Site Number 840027, Los Angeles, California, United States

🇺🇸

Investigational Site Number 840009, Boca Raton, Florida, United States

🇺🇸

Investigational Site Number 840015, Boise, Idaho, United States

and more 77 locations
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