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

Phase 1

• Conditions: Multiple sclerosis

• Registration Number: EUCTR2008-006226-34-GR
• Lead Sponsor: sanofi-aventis recherche et development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-19
• Last Update Posted: 10 October 2016

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
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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effectiveness of 2 doses of teriflunomide in comparison to interferon-beta 1a, evaluated by the time to failure, with failure being defined as either relapse or permanent study treatment discontinuation for any cause whichever comes first.;Secondary Objective: To assess the effect of 2 doses of teriflunomide in comparison to interferon-beta 1a, on:<br>- Frequency of relapses,<br>- Fatigue,<br>- Patient’s satisfaction with treatment.<br>To evaluate the safety and tolerability of 2 doses of teriflunomide in comparison to interferon-beta 1a.<br>An optional Pharmacogenomic Teriflunomide Substudy aims at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes.<br>;Primary end point(s): Time to failure, defined as the first occurrence of relapse or permanent study treatment discontinuation for any cause whichever comes first.