A 4-MONTH, OPEN-LABEL, MULTICENTER STUDY TO EXPLORE THE SAFETY AND TOLERABILITY OF FINGOLIMOD 0.5 MG IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS.

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 27 人开始时间: 2012年4月23日最近更新: 2023年9月4日

研究概览

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•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.

•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

发起方

OVARTIS BIOSCIENSES PERU S.A.,