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Friday, October 31, 2014
Sanofi Recruiting for Teriflunomide ( AUBAGIO® ) Phase 4 Study
information showing below, was in-part obtained from the MSF
Sanofi is seeking recruits for a Phase 4 study to describe effectiveness, tolerability, and convenience of teriflunomide treatment through the evaluation of patient-reported outcomes.
The total duration of the study per patient is up to 50 or 54 weeks (if accelerated elimination procedure is performed), including screening for up to two weeks, teriflunomide treatment for 48 weeks, and accelerated elimination procedure for four weeks, when performed. An accelerated elimination procedure at any time after discontinuation of teriflunomide treatment is possible, and it is particularly recommended for women of child-bearing potential.
Male and female MS patients with a relapsing form of multiple sclerosis having signed written informed consent and are 18 years and older are eligible to participate.
Exclusion criteria includes, according to local labeling, less than 18 years of age, current or history of receiving teriflunomide, previous treatment with leflunomide within six months prior to baseline, patients with pre-existing acute or chronic liver disease, or those with serum alanine aminotransferase greater than two times the upper limit of normal, known history of active tuberculosis or latent TB infection, known history of severe immunodeficiency, acquired immunodeficiency syndrome, bone marrow disease, acute or severe active infections, women who are pregnant or breast-feeding, female patients with a positive pregnancy test at screening or women of child-bearing potential who do not agree to use reliable contraception throughout the course of the study, male patients (only when required according to local labeling) unwilling to use reliable contraception during the course of the study, hypersensitivity to the active substance or to any of the excipients, other additional contraindications per local labeling. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
To learn more about this study and find the investigation site nearest to you, visit clinicaltrials.gov/ct2/show/NCT01895335?term=multiple+sclerosis&recr=Open&cntry1=NA%3AUS&phase=23&rank=2.
You or your doctor may contact the study research staff using the contacts provided.
Refer to this study by its ClinicalTrials.gov identifier: NCT01895335.
For investigation site information, send an email with site number to Contact-Us@sanofi.com.
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