A 12-month double-blind, randomized, multicenter, active-controlled, parallel-group study comparing the efficacy and safety of two doses of fingolimod FTY720 0.5 mg and 1.25 mg administered orally once daily versus interferon beta-1a Avonex administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302

Conditions: Relapsing-remitting multiple sclerosis
MedDRA version: 6.1Level: PTClassification code 10028245

Registration Number: EUCTR2006-000704-17-IT

Lead Sponsor: OVARTIS FARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1275

Inclusion Criteria

Patients who meet all of the following inclusion criteria during the Pre-Randomization Phase will be eligible for enrollment in the study General 1. male or female females of childbearing potential must have a negative pregnancy test at Baseline prior to entry into the Double-Blind Treatment Phase or be either post-menopausal for 12 months prior to Screening 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. sign written informed consent prior to participating in the study Multiple sclerosis 4. diagnosis of multiple sclerosis as defined by 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 6. an Expanded Disability Status Scale EDSS score of 0-5.5 inclusive at Baseline. 7. neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to baseline
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

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 seizures within 3 months of Baseline 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 if screening blood glucose is suspicious for diabetes 8805;126 mg/dL or 8805;7 mmol/L if fasting and 8805;200 mg/dL or 11.1 mmol/L if random testing a patient should be further evaluated for diabetes mellitus 6.a diagnosis of macular edema during Pre-randomization Phase 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 in the past 1 month IFN- or glatiramer acetate in the past 3 months immunosuppressive medications such as azathioprine or methotrexate in the past 6 months immunoglobulins and/or monoclonal antibodies including natalizumab in the past 6 months 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 history of cardiac arrest myocardial infarction within the past 6 months prior to enrollment or current unstable ischemic heart disease cardiac failure at time of Screening Class III, according to New York Heart Association Classification or any severe cardiac disease as determined by the investigator past or current history of recurrent symptomatic bradycardia 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 resting pulse rate 55 bpm during Pre-randomization Phase proven history of sick sinus syndrome or sino-atrial heart block history of vagal syncope with a positive tilt test known history of angina pectoris due to coronary spasm or history of Raynaud s phenomenon hypertension, not controlled by prescribed medications BP 8805;140/90 mm Hg 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 x-ray 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 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-glutamyl-transfera