Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients
Launched by SANOFI · Feb 2, 2010
Trial Information
Current as of May 04, 2025
Completed
Keywords
ClinConnect Summary
The total study duration for a participant was 16-22 weeks (Part A) and 56-62 weeks (Part B) broken down as follows:
* Screening: Up to 4 weeks
* Treatment: 12 weeks (Part A) and 52 weeks (Part B)\*
* Follow-up: 6 weeks (for participants who would not continue in the long-term extension study).
'\*' Participants successfully completing their treatment period would be offered the opportunity to enter the long term extension study LTS11210 (SARIL-RA-EXTEND) (NCT01146652).
Gender
ALL
Eligibility criteria
- Inclusion criteria :
- • Diagnosis of rheumatoid arthritis ≥3 months duration
- * Active disease defined as:
- • at least 8/68 tender joints and 6/66 swollen joints,
- • high sensitivity C-reactive protein (hs-CRP) \>6 mg/l,
- • continuous treatment with MTX for at least 12 weeks prior to baseline visit and on stable dose for at least 6 weeks prior to screening visit.
- Part B only:
- • Bone erosion based on documented X-ray prior to first study drug intake, or
- • Cyclic Citrullinated Peptide (CCP) positive, or
- • Rheumatoid Factor (RF) positive.
- Exclusion criteria:
- • Age \<18 years or \>75 years.
- • Treatment with disease-modifying antirheumatic drugs (DMARDs) other than MTX within 4 weeks or 12 weeks prior to screening (depending on DMARDs).
- • Past history of non-response to prior Tumor Necrosis Factor (TNF) or biologic treatment.
- • Any past or current biologic agents for the treatment of rheumatoid arthritis within 3 months.
- • Use of parenteral glucocorticoids or intraarticular glucocorticoids within 4 weeks prior to screening visit.
- • Use of oral glucocorticoid greater than 10mg/day or equivalent/day, or a change in dosage within 4 weeks prior to baseline visit.
- • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
About Sanofi
Sanofi is a global healthcare leader dedicated to empowering life through innovation in pharmaceuticals and vaccines. With a strong commitment to research and development, Sanofi focuses on addressing complex health challenges across various therapeutic areas, including diabetes, oncology, immunology, and rare diseases. The company leverages advanced science and technology to develop transformative therapies that improve patient outcomes. Through collaborative partnerships and a patient-centric approach, Sanofi strives to enhance global health and deliver sustainable solutions that meet the evolving needs of healthcare systems and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Graz, , Austria
Heraklion, , Greece
Incheon, , Korea, Republic Of
Kaunas, , Lithuania
Medellin, , Colombia
Seoul, , Korea, Republic Of
Vilnius, , Lithuania
Aveiro, , Portugal
Durban, , South Africa
Athens, , Greece
Veszprém, , Hungary
Bangkok, , Thailand
Helsinki, , Finland
Wien, , Austria
Newmarket, , Canada
Toronto, , Canada
Praha 2, , Czechia
Erlangen, , Germany
Frankfurt Am Main, , Germany
Hamburg, , Germany
Herne, , Germany
Debrecen, , Hungary
Sátoraljaújhely, , Hungary
Bialystok, , Poland
Krakow, , Poland
Ankara, , Turkey
Izmir, , Turkey
Anniston, Alabama, United States
Birmingham, Alabama, United States
Gilbert, Arizona, United States
Beverly Hills, California, United States
Palm Desert, California, United States
San Francisco, California, United States
Santa Maria, California, United States
Upland, California, United States
Dunedin, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
Sarasota, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Marietta, Georgia, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
Cumberland, Maryland, United States
Frederick, Maryland, United States
Wheaton, Maryland, United States
Saint Louis, Missouri, United States
Omaha, Nebraska, United States
New York, New York, United States
Hickory, North Carolina, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Tulsa, Oklahoma, United States
Bethlehem, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Reading, Pennsylvania, United States
Columbia, South Carolina, United States
North Charleston, South Carolina, United States
Jackson, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Lubbock, Texas, United States
Mesquite, Texas, United States
Tacoma, Washington, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Caba, , Argentina
Cordoba, , Argentina
Córdoba, , Argentina
Mar Del Plata, , Argentina
Quilmes, , Argentina
Ramos Mejia, , Argentina
Rosario, , Argentina
Tucuman, , Argentina
Zarate, , Argentina
Camperdown, , Australia
Clayton, , Australia
East Malvern, , Australia
Fitzroy, , Australia
Garran, , Australia
Heidelberg West, , Australia
Herston, , Australia
Maroochydore, , Australia
St Leonards, , Australia
Sydney, , Australia
Victoria Park, , Australia
Woodville, , Australia
Minsk, , Belarus
Minsk, , Belarus
Genk, , Belgium
Liège, , Belgium
Campinas, , Brazil
Campinas, , Brazil
Curitiba, , Brazil
Goiania, , Brazil
Juiz De Fora, , Brazil
Porto Alegre, , Brazil
Rio De Janeiro, , Brazil
Salvador, , Brazil
Sao Paulo, , Brazil
Sao Paulo, , Brazil
Vitoria, , Brazil
Burlington, , Canada
Mississauga, , Canada
St. Catharines, , Canada
Toronto, , Canada
Winnipeg, , Canada
Osorno, , Chile
Puerto Montt, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Talca, , Chile
Valdivia, , Chile
Vina Del Mar, , Chile
Viña Del Mar, , Chile
Barranquilla, , Colombia
Bogota, , Colombia
Bogota, , Colombia
Bogotá, , Colombia
Bogotá, , Colombia
Bucaramanga, , Colombia
Bucaramanga, , Colombia
Brno, , Czechia
Hlucin, , Czechia
Uherske Hradiste, , Czechia
Cairo, , Egypt
Cairo, , Egypt
Tallinn, , Estonia
Tallinn, , Estonia
Hyvinkää, , Finland
Pori, , Finland
Berlin, , Germany
Berlin, , Germany
Halle/Saale, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Hildesheim, , Germany
Thessaloniki, , Greece
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Eger, , Hungary
Gy?R, , Hungary
Szombathely, , Hungary
Ahmedabad, , India
Bangalore, , India
Chennai, , India
Hyderabad, , India
Hyderabad, , India
Lucknow, , India
Lucknow, , India
Maharashtra, , India
Mumbai, , India
Mumbai, , India
New Delhi, , India
New Delhi, , India
Anyang, , Korea, Republic Of
Busan, , Korea, Republic Of
Daegu, , Korea, Republic Of
Daegu, , Korea, Republic Of
Daejeon, , Korea, Republic Of
Gwangju, , Korea, Republic Of
Incheon, , Korea, Republic Of
Jeonju, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Suwon, , Korea, Republic Of
Ipoh, , Malaysia
Kuching, , Malaysia
Putrajaya, , Malaysia
Durango, , Mexico
Guadalajara, , Mexico
Merida, , Mexico
Merida, , Mexico
Metepec, , Mexico
Mexico City, , Mexico
Mexico, D.F., , Mexico
Monterrey, , Mexico
Heerlen, , Netherlands
Christchurch, , New Zealand
Rotorua, , New Zealand
Tauranga, , New Zealand
Timaru, , New Zealand
Kristiansand, , Norway
Tønsberg, , Norway
Cebu City, , Philippines
Manila, , Philippines
Manila, , Philippines
Bialystok, , Poland
Lublin, , Poland
Torun, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Lisboa, , Portugal
Lisboa, , Portugal
Braila, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Galati, , Romania
Ploiesti, , Romania
Kemerovo, , Russian Federation
Kemerovo, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Novosibirsk, , Russian Federation
Ryazan, , Russian Federation
Saint Petersburg, , Russian Federation
Samara, , Russian Federation
Saratov, , Russian Federation
St Petersburg, , Russian Federation
St Petersburg, , Russian Federation
Ufa, , Russian Federation
Cape Town, , South Africa
Cape Town, , South Africa
Cape Town, , South Africa
Durban, , South Africa
Johannesburg, , South Africa
Kempton Park, , South Africa
Pretoria, , South Africa
Pretoria, , South Africa
Pretoria, , South Africa
Stellenbosch, , South Africa
Barcelona, , Spain
La Coruña, , Spain
Sabadell, , Spain
Santiago De Compostela, , Spain
Sevilla, , Spain
Linkou, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Adana, , Turkey
Ankara, , Turkey
Antalya, , Turkey
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Kharkov, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Simferopol, , Ukraine
Zaporizhzhia, , Ukraine
Patients applied
Trial Officials
Mark C Genovese, MD, Professor of Medicine
Principal Investigator
Division of Immunology and Rheumatology - Stanford University - USA
TWJ Huizinga, Prof Dr
Study Chair
Dpt of Rheumatology - Leiden University Medical Center - The Netherlands
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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