EUCTR2008-006226-34-ITActive, not recruitingNot Applicable
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 sclerosisA 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
sanofi-aventis recherche et development0 sites300 target enrollmentStarted: March 9, 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion 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
- •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
Investigators
Similar Trials
Active, not recruiting
Not Applicable
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 plus a long-term extension period. - TENEREMultiple sclerosisEUCTR2008-006226-34-BEsanofi-aventis recherche et development300
Active, not recruiting
Not Applicable
A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (TENERE)Multiple sclerosisMedDRA version: 14.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2008-006226-34-GBsanofi-aventis recherche et developpement300
Active, not recruiting
Phase 1
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 sclerosisA 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. - TENEREMultiple sclerosisEUCTR2008-006226-34-GRsanofi-aventis recherche et development300
Active, not recruiting
Not Applicable
A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (TENERE)MedDRA version: 13.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMultiple sclerosisEUCTR2008-006226-34-CZsanofi-aventis recherche et developpement300
Active, not recruiting
Not Applicable
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 - TENEREMultiple sclerosisEUCTR2008-006226-34-FRsanofi-aventis Recherche & Dévelopment300