None listed
Conditions
Interventions
UPON SIGNING THE INFORMED CONSENT, PATIENTS WILL BE TRANSFERRED INTO THIS STUDY FORM ONE OF THE ONGOING FINGOLIMOD CORE/EXTENSION STUDIES (CFTY720D2201/E1, CFTY720D2301/E1, CFTY720D2302/E1, CFTY720D23
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. WRITTEN INFORMED CONSENT MUST BE OBTAINED BEFORE ANY ASSESSMENT IS PERFORMED. 2. PATIENTS WHO HAVE COMPLETED DESIGNATED ONGOING OR PLANNED TRIALS WITH FINGOLIMOD, INCLUDING PHASE II/III PATIENTS WHO HAVE ALREADY COMPLETED CFTY72D2399, CFTY720D2309/E1 OR ONE OF THE PHASE II/III EXTENSION STUDIES 3. PATIENTS WHO PARTICIPATED IN ANY DESIGNATED GLOBAL FINGOLIMOD MS TRIAL OTHER THAN PHASE II/III (.G., CFTY720D2316, CFTY720D2320, ETC.) AND ARE LESS THAN 180 DAYSBEYOND THE TIME OF LOCAL APPROVAL AND GENERAL REIMBURSEMENT.
Exclusion criteria
Exclusion criteria: 1. PREMATURE PERMANENT DISCONTINUATION FROM ANY FINGOLIMOD STUDY DUE TO: A. AN ADVERSE EVENT OR SERIOUS ADVERSE EVENT OR LABORATORY ABNORMALITY, EXCEPT PREGNANCY. B. CONDITIONS LEADING TO PERMANENT STUDY DRUG DISCONTINUATION. 2. PREGNANT OR NURSING (LACTATING) WOMEN WHERE PREGNANCY IS DEFINED AS THE STATE OF A FEMALE AFTER CONCEPTION AND UNTIL THE TERMINATION OF GESTATION, CONFIRMED BY A POSITIVE HCG LABORATORY TEST (> 5 MIU/M1). 3. WOMEN OF CHILD-BEARING POTENTIAL DEFINED AS ALL WOMEN PHYSIOLOGICALLY CAPABLE OF BECOMING PREGNANT, UNLESS THEY ARE USING HIGHLY EFFECTIVE CONTRACEPTION DURING THE STUDY AND FOR 2 MONTHS AFTER STOPPING TREATMENT. “HIGHLY EFFECTIVE CONTRACEPTION”DEFINED AS CONTRACEPTION WHICH RESULTS IN LESS THAT 1 % UNANTED PREGNANCIES WHEN USED PROPERLY ACCORDING TO THE LABEL. WOMEN ARE CONSIDERED POST-MENOPAUSAL AND NOT OF CHILD-BEARING POTENTIAL IF THEY HAVE HAD 12 MONTHS OF NATURAL (SPONTANEOUS) AMENORRHEA WITH AN APPROPIATE CLINICAL PROFILE (E.G., AGE APPROPRIATE, HISTORY OF VASOMOTOR SYNPTOMS) OR HAVE HAD SURGICAL BILATERAL OOPHORECTOMY (WITH OR WITHOUT HYSTERECTOMY) OR TUBAL LIGATION AL LEAST SIX WEEKS PRIOR TO BASELINE. IN THE CASE OF OOPHORECTOMY ALNE, ONLY WHEN THE REPRODUCTIVE STATUS OF THE WOMAN HAS BEEN CONFIRMED BY FOLLOW UP HORMONE LEVEL ASSESSMENT IS THE CONSIDERED NOT OF CHILD BEARING POTENTIAL.
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Ireland, Israel, Italy, Korea North, Malasya, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kindgdom, United States
Contacts
Public ContactPamela Olaechea
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed