A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis - TENERE

• Conditions: Multiple sclerosis

• Registration Number: EUCTR2008-006226-34-FR
• Lead Sponsor: sanofi-aventis Recherche & Dévelopment

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-25
• Last Update Posted: 11 September 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
;
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

;
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