Estudio internacional multicéntrico, doble ciego, aleatorizado, de grupos paralelos, con control activo y de 12 meses de duración para comparar la eficacia y seguridad de 0.5 mg y 1.25 mg de fingolimod (FTY720) administrado por vía oral una vez al día respecto a interferon Beta-1a (Avonex®) administrado por vía i.m una vez a la semana, en pacientes con esclerosis múltiple remitente-recurrente - D2302

Conditions: Esclerosis múltiple remitente-recurrente

Registration Number: EUCTR2006-000704-17-ES

Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1275

Inclusion Criteria

General
1. male or female;
• females of childbearing potential must: have negative pregnancy tests prior to entry into the Double-Blind Treatment Phase, or be either post-menopausal for 12 months prior to Randomization or surgically sterile, or use adequate contraception during the treatment and 3 months after discontinuation of the study medication
2. 18 through 55 years of age inclusive
3. signed written informed consent prior to participating in the study.

Multiple sclerosis
4. diagnosis of multiple sclerosis as defined by 2005 revised McDonald criteria
5. a relapsing-remitting course with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years; prior to randomization
6. an Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive
7. neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization

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)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who meet any of the following exclusion criteria during the Pre-Randomization Phase will not be eligible for enrollment in the study:
1. a manifestation of MS other than RRMS
2. a history of chronic disease of the immune system other than MS or a known
immunodeficiency syndrome
3. a history of epileptic seizures within 3 months of randomization
4. a history or presence of malignancy (except for successfully treated basal or squamous cell carcinoma of skin)
5. a known or ‘new’ diagnosis of diabetes mellitus
6. a diagnosis of macular edema during Pre-randomization Phase (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at the ophthalmic screening visit).
7. active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively
8. have received total lymphoid irradiation or bone marrow transplantation
9. have been treated with:
• corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to randomization
• immunosuppressive medications such as azathioprine or methotrexate within 6 months prior to randomization
• immunoglobulins and/or monoclonal antibodies (including natalizumab) within 6 months prior to randomization
• cladribine, cyclophosphamide or mitoxantrone at any time
10. any medically unstable condition, as assessed by the primary treating physician
11. any of the following cardiovascular conditions:
• myocardial infarction within the past 6 months prior to enrollment or current unstable ischemic heart disease
• history of angina pectoris due to coronary spasm or history of Raynaud’s phenomenon
• cardiac failure at time of Screening (Class III, according to NYHA Classification; or any severe cardiac disease as determined by the investigator
• history of cardiac arrest
• history of symptomatic bradycardia
• resting pulse rate <55 bpm prior to randomization
• history of sick sinus syndrome or sino-atrial heart block
• history or presence of a second degree AV block or a third degree AV block or an increased QTc interval >440 ms on Screening ECG
• arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide)
• history of a positive tilt test from workup for vasovagal syncope
• hypertension, uncontrolled by medication
12. any of the following pulmonary conditions:
• severe respiratory disease or pulmonary fibrosis
• tuberculosis, except for history of successfully treated tuberculosis or history of prophylactic treatment after positive PPD skin reaction
• abnormal chest High Resolution Computer Tomography (HRCT) [or chest x-ray in case HRCT is not permitted by local regulations] suggestive of active pulmonary
disease
• abnormal Pulmonary Function Tests: FEV1;, FVC values lower than 70% of predicted value, DLCO values lower than 60% of predicted value
• patients receiving daily therapies for asthma
13. any of the following hepatic conditions:
• known history of alcohol abuse, chronic liver or biliary disease, with the exception of Gilbert’s syndrome
• total or conjugated bilirubin greater than the upper limit of the normal range
• alkaline phosphatase (AP) greater than 1.5 times the upper limit of the normal range
• AST (SGOT), ALT (SGPT) greater than 2 times the upper limit of the normal range
• gamma-glut