None listed
Conditions
Interventions
AFTER SIGNING INFORMED CONSENT, PATIENTS WILL ENTER A SCREENING PHASE (-2 to -1 WEEK) TO DETERMINE ELIGIBILITY FOR THE STUDY. UPON ELIGIBILITY PATIENTS WILL ENTER THE 16 WEEK OPEN-LABEL TREATMENT PHAS
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: PATIENTS ELIGIBLE FOR INCLUSION IN THIS STUDY HAVE TO FULFILL ALL TO THE FOLLOWING CRITERIA: 1. WRITTEN INFORMED CONSENT MUST BE OBTAINED BEFORE ANY ASSESSMENT IS PERFORMED. 2. MALE AND FEMALE PATIENTS AGED 18-65 (AT THE TIME OF INFORMED CONSENT). 3. SUBJECTS WITH RELAPSING REMITTING MS, DEFINED BY 2005 REVISED MCDONALD CRITERIA. 4. PATIENTS WITH EXPANDED DISABILITY STATUS SCALE (EDSS) SCORE OF 0-6.5.
Exclusion criteria
Exclusion criteria: PATIENTS FULFILLING ANY OF THE FOLLOWING CRITERIA ARE NOT ELIGIBLE FOR INCLUSION IN THIS STUDY: 1. PATIENTS WITH A MANIFESTATION OF MS OTHER THAN RELAPSING REMITTING MS. 2. PATIENTS WITH A HISTORY OF CHRONIC DISEASE OF THE IMMUNE SYSTEM OTHER THAN MS, WHICH REQUIRES SYSTEMIC IMMUNOSUPPRESSIVE TREATMENT, OR A KNOWN IMMUNODEFICIENCY SYNDROME. 3. PATIENTS WHO HAVE BEEN TREATED WITH: . SYSTEMIC CORTICOSTEROIDS OR IMMUNOGLOBULINS WITHIN 1 MONTH PRIOR BASELINE; . IMMUNOSUPPRESSIVE MEDICATIONS SUCH AS AZATHIOPRINE, CYCLOPHOSPHAMIDE, OR METHOTREXATE WITHIN 3 MONTHS PRIOR TO BASELINE; . MONOCLONAL ANTIBODIES (INCLUDING NATALIZUMAB) WITHIN 3 MONTHS PRIOR TO BASELINE; . CLADRIBRINE, MITOXANTRONE OR ALEMTUZUMAB AT ANY TIME. 4. HISTORY OF MALIGNANCY OF ANY ORGAN SYSTEM (OTHER THAN CUTANEOUS BASAL CELL CARCINOMA). 5. UNCONTROLLED DIABETES MELLITUS (HbA1c>7%) AT SCREENING. 6. DIAGNOSIS OF MACULAR EDEMA DURING SCREENING PHASE (PATIENTS WITH A HISTORY OF MACULAR EDEMA WILL BE ALLOWED TO ENTER THE STUDY PROVIDED THAT THEY DO NOT HAVE MACULAR EDEMA AL THE SCREENING VISIT). 7. PATIENTS WITH ACTIVE SYSTEMIC BACTERIAL, VIRAL OR FUNGAL INFECTIONS, OR KNOWN TO HAVE AIDS, HEPATITIS B, HEPATITIS C INFECTION OR TO HAVE POSITIVE HIV ANTIBODY, HEPATITIS B SURFACE ANTIGEN OR HEPATITIS C ANTIBODY TESTS. 8. NEGATIVE FOR VARICELLA-ZOSTER VIRUS IgG ANTIBODIES PRIOR TO BASELINE. 9. HAVE RECEIVED ANY LIVE OR LIVE ATTENUATED VACCINES (INCLUDING FOR VARICELLA-ZOSTER VIRUS
Countries
Argentina, Brazil, Colombia, Costa Rica, Jordan, Malasya, Mexico, Panama, Peru
Contacts
Public ContactPamela Olaechea
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed