Status:
TERMINATED
Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta
Lead Sponsor:
Sanofi
Conditions:
Multiple Sclerosis Relapse
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated ...
Detailed Description
The study period per patient was expected to be between 56 and 160 weeks depending on when the patient was randomized and this included the following: * a screening period up to 4 weeks, * a treatmen...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Patient with relapsing forms of MS treated with IFN-beta
- Stable dose of IFN-beta (approved brand) for at least 6 months prior to randomization
- Disease activity in the 12 months prior to randomization and after first 3 months of IFN-beta treatment (defined by at least 1 relapse supported by EDSS or equivalent neurological examination, or, at least 1 brain or spinal cord MRI with at least one T1 gadolinium enhancing lesion)
- Exclusion criteria:
- McDonald criteria for MS diagnosis not met at time of screening visit
- EDSS score greater than (\>) 5.5 at randomization visit
- A relapse within 30 days prior randomization
- Persistent significant or severe infection
- Patients must not have used adrenocorticotrophic hormone or systemic corticosteroids for 2 weeks prior to randomization
- Prior or concomitant use of cytokine therapy (except baseline interferons), glatiramer acetate or intravenous immunoglobulins in the 3 months preceding randomization
- Liver function impairment or persisting elevations (confirmed by retest) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or direct bilirubin greater than 2 times the upper limit of normal range (ULN)
- Active hepatitis or hepatobiliary disease or known history of severe hepatitis
- Pregnant or breast-feeding women or those who were planning to become pregnant during the study
- Significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia
- Human Immunodeficiency Virus (HIV) positive
- Known history of active tuberculosis not adequately treated
- Prior use within 2 years preceding randomization or concomitant use of cladribine and mitoxantrone
- Prior use within 6 months preceding randomization or concomitant use of natalizumab, or any other immunosuppressive agents such as azathioprine, cyclophosphamide, cyclosporine, methotrexate, mycophenolate, or fingolimod
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
534 Patients enrolled
Trial Details
Trial ID
NCT01252355
Start Date
January 1 2011
End Date
April 1 2013
Last Update
June 9 2014
Active Locations (185)
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1
Investigational Site Number 840049
Cullman, Alabama, United States, 35058
2
Investigational Site Number 840005
Cordova, Alaska, United States, 38018
3
Investigational Site Number 840003
Phoenix, Arizona, United States, 85060
4
Investigational Site Number 840011
Oceanside, California, United States, 92056