An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis
Launched by SANOFI · Sep 11, 2008
Trial Information
Current as of May 13, 2025
Completed
Keywords
ClinConnect Summary
The study consists of:
* A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo was administered in double-blind fashion until a fixed common end date which was approximately 48 weeks after randomization of the last participant.
* An extension treatment period: the highest dose of teriflunomide was administered in open-label fashion to participants who successfully complete the core treatment period and wish to continue.
The overall treatment period was followed by a 4-week elimination follow-up period.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Relapsing multiple sclerosis,
- • Two relapses in prior 2 years or one relapse in prior year.
- Exclusion Criteria:
- • Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
- • Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,
- • Pregnant or nursing woman,
- • Alcohol or drug abuse,
- • Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,
- • Human immunodeficiency virus (HIV) positive,
- • Any known condition or circumstance that would prevent, in the investigator's opinion, compliance or completion of the study.
- • 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
Tartu, , Estonia
Barcelona, , Spain
Bangkok Noi, , Thailand
Bangkok, , Thailand
Phoenix, Arizona, United States
Tucson, Arizona, United States
Loma Linda, California, United States
Modesto, California, United States
Fort Collins, Colorado, United States
Fairfield, Connecticut, United States
Maitland, Florida, United States
Ocala, Florida, United States
Ormond Beach, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Sunrise, Florida, United States
Elk Grove Village, Illinois, United States
Flossmoor, Illinois, United States
Ft Wayne, Indiana, United States
Indianapolis, Indiana, United States
Des Moines, Iowa, United States
Clinton Township, Michigan, United States
Grand Rapids, Michigan, United States
Traverse City, Michigan, United States
Minneapolis, Minnesota, United States
Tupelo, Mississippi, United States
St. Louis, Missouri, United States
Syracuse, New York, United States
Charlotte, North Carolina, United States
Bismarck, North Dakota, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Greenville, South Carolina, United States
Cordova, Tennessee, United States
Nashville, Tennessee, United States
San Antonio, Texas, United States
Bennington, Vermont, United States
Seattle, Washington, United States
Charleston, West Virginia, United States
Bedford Park, , Australia
Chatswood, , Australia
Fitzroy, , Australia
Geelong, , Australia
Heidelberg, , Australia
New Lambton, , Australia
Sydney, , Australia
Wien, , Austria
Grodno, , Belarus
Minsk, , Belarus
Minsk, , Belarus
Minsk, , Belarus
Vitebsk, , Belarus
Brugge, , Belgium
Leuven, , Belgium
Melsbroek, , Belgium
Sijsele Damme, , Belgium
Gatineau, , Canada
Kingston, , Canada
Montreal, , Canada
Ottawa, , Canada
Quebec, , Canada
Regina, , Canada
Saint John, , Canada
Santiago, , Chile
Santiago, , Chile
Viña Del Mar, , Chile
Baotou, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Changchun, , China
Chengdu, , China
Guangzhou, , China
Guangzhou, , China
Haikou, , China
Hangzhou, , China
Jinan, , China
Nanjing, , China
Nanjing, , China
Qingdao, , China
Shanghai, , China
Shanghai, , China
Shenyang, , China
Shijiazhuang, , China
Suzhou, , China
Taiyuan, , China
Tianjin, , China
Tianjin, , China
Wenzhou, , China
Wuhan, , China
Xi'an, , China
Xi'an, , China
Brno, , Czech Republic
Ostrava Poruba, , Czech Republic
Teplice, , Czech Republic
Tallinn, , Estonia
Besancon, , France
Dijon Cedex, , France
Lyon Cedex 03, , France
Nantes Cedex 01, , France
Nice Cedex, , France
Nimes, , France
Poissy, , France
Bamberg, , Germany
Bayreuth, , Germany
Berlin, , Germany
Erlangen, , Germany
Gießen, , Germany
Hannover, , Germany
Leipzig, , Germany
Magdeburg, , Germany
Wiesbaden, , Germany
Athens, , Greece
Thessaloniki, , Greece
Monterrey, , Mexico
México, , Mexico
'S Hertogenbosch, , Netherlands
Breda, , Netherlands
Groesbeek, , Netherlands
Nieuwegein, , Netherlands
Sittard Geleen, , Netherlands
Cebu City, , Philippines
Makati City, , Philippines
Manila, , Philippines
Quezon City, , Philippines
Gdansk, , Poland
Lodz, , Poland
Lublin, , Poland
Szczecin, , Poland
Warszawa 44, , Poland
Bacau, , Romania
Brasov, , Romania
Bucuresti, , Romania
Oradea, , Romania
Bratislava 2, , Slovakia
Bratislava 2, , Slovakia
Martin, , Slovakia
Presov, , Slovakia
Getafe, , Spain
Girona, , Spain
Madrid, , Spain
Sevilla, , Spain
Stockholm, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Manouba, , Tunisia
Sfax, , Tunisia
Tunis, , Tunisia
Tunis, , Tunisia
Edirne, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Izmir, , Turkey
Kocaeli, , Turkey
Manisa, , Turkey
Samsun, , Turkey
Trabzon, , Turkey
Chernihiv, , Ukraine
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Donetsk, , Ukraine
Ivano Frankovsk, , Ukraine
Kharkiv, , Ukraine
Kharkov, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Lutsk, , Ukraine
Lutsk, , Ukraine
Lviv, , Ukraine
Lviv, , Ukraine
Poltava, , Ukraine
Vinnytsya, , Ukraine
Zaporizhya, , Ukraine
Zaporizhzhia, , Ukraine
Zaporozhye, , Ukraine
Edinburgh, , United Kingdom
Haywards Heath, , United Kingdom
Irvine, , United Kingdom
Leeds, , United Kingdom
Salford, , United Kingdom
Patients applied
Trial Officials
Clinical Sciences & Operations
Study Director
Sanofi
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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