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.
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.
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.
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.
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.
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.
provided.
Refer to this study by its ClinicalTrials.gov identifier:
NCT01895335.
NCT01895335.
For investigation site information, send an email with site number
to [email protected].
to [email protected].
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