A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (TENERE)

• Conditions: Multiple sclerosis; MedDRA version: 14.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2008-006226-34-GB
• Lead Sponsor: sanofi-aventis recherche et developpement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-01
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Patients with relapsing forms of multiple sclerosis meeting McDonald’s criteria for MS diagnosis at time of screening visit, and EDSS score =5.5 at screening visit.
Provided informed consent with signature on informed consent form

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 299
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

Exclusion (key):
• <18 years of age
• Patients with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia
• Persistent significant or severe infection
• Liver function impairment or persisting elevations (confirmed by retest) of serum glutamic pyruvic transaminase (SGPT/ALT), serum glutamic oxaloacetic transaminase (SGOT/AST), or direct bilirubin greater than 1.5-fold the upper limit of normal
• Known history of hepatitis
• Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 2 weeks prior to randomization
• Human immunodeficiency virus (HIV) positive patients
• Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate
• Prior or concomitant use of natalizumab (Tysabri®)
• Pregnant or breast-feeding women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified