Estudio multicéntrico, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad de teriflunomida en pacientes con esclerosis múltiple recurrente_________________________________________________________________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER

• Conditions: Esclerosis múltiple_____________Multiple sclerosis; MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis

• Registration Number: EUCTR2007-004452-36-ES
• Lead Sponsor: Sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-23
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1110

Inclusion Criteria

Patients with relapsing forms of Multiple Sclerosis meeting McDonald’s criteria for MS diagnosis at time of screening, and EDSS scores of = 5.5 at screening.

Experienced at least 1 relapse in the previous 12 months preceeding randomization, or at least 2 relapses in the 24 months preceeding randomization visit.

Patients who Have provided informed consent with signature on informed consent form: the informed consent process should be complete with full discussion of approved therapies available for relapsing forms of MS. The patient must have been offered these therapies and must choose to join the study instead of accepting therapy outside of the study.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• <18 years of age or =56 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 effect of 2 doses of teriflunomide in comparison to placebo, on frequency of MS (multiple sclerosis) relapses in patients with relapsing MS.;Secondary Objective: Key secondary:<br>- To assess the effect of 2 doses of teriflunomide in comparison to placebo, on disability progression in patients with relapsing MS.<br><br>Other secondary:<br>- To assess other measures of efficicacy of 2 doses of teriflunomide in comparison to placebo, on: <br> o Fatigue,<br> o Health-related quality of life, a measure of the impact of the patient’s health on his or her overall well being.<br><br>- To evaluate the safety and tolerability of teriflunomide<br><br><br>;Primary end point(s): - Annualized relapse rate, defined as number of relapses per patient-year