A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis.----------------------------------------------------------------------------------------------------------Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias”.
- Conditions
- Multiple sclerosis.Esclerosis Múltiple.
- Registration Number
- EUCTR2006-003134-14-ES
- Lead Sponsor
- Sanofi-aventis U.S. Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
- Patients of both gender aged 18 to 55 years with a diagnosis of multiple sclerosis (as defined by McDonald's criteria) who are ambulatory (Expanded Disability Status Scale [EDSS] of < or = to 5.5).
-Stable dose of IFN-béta for at least 26 weeks prior to the screening visit
-No onset of MS relapse in the preceding 60 days prior to randomization
-Clinically stable for 4 weeks prior to randomization
-Main informed consent and informed consent for HIV testing forms signed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
*disease related:
-cancer, lymphoproliferative disease or lymphoïd irradiation
-Impaired bone marrow function; significant anemia, leukopenia, or thrombocytopenia
-Congenital or acquired severe immunodeficiency, HIV positive subjects, persistent significant or severe infection, tuberculosis
-Liver function impairment or persisting elevation of alanine transaminase(ALT) aspartate transferase (AST), or direct bilirubine >1.5 fold the upper limit of normal (ULN)
- Persisting elevations of serum amylase or lipase greater to 2-fold the upper limit of normal
-chronic pancreatic disease or pancreatitis, chronic active hepatitis
-Hypoprotéinemia
-Moderate to severe impairment of renal function
-Clinically relevant cardiovascular, hypertensive, hepatic, neurological, endocrine, or other systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the subject at risk by participing in the study
*Prior or concomitant use or likelihood of requiring treatment during the study period with drugs not permitted
- cladribine, mitoxantrone, azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate.
- St.John's Wort, phenytoin, warfarin, tolbutamide or cholestyramine; adrenocorticotropic hormone (ACTH) or systemic corticosteroids within 4 weeks prior to randomization (minimum 4 weeks before randomization)
-natalizumab TYSABRI
-glatiramer acetate or cytokine therapy, immunoglobins or any investigational drug in the preceding 24 weeks
- Previous treatment with teriflunomide or leflunomide (ARAVA)
*Contra-indicating for MRI
*Other
-Pregnancy, breastfeeding, wishing to parent children
-History of drug or alcohol abuse
-Mental condition rendering the subject unable to understand the nature, scope, and possible consequence of the study
-Subject unlikely to comply with protocol
-Subject involved in the conduct of protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method