None listed
Conditions
Brief summary
The purpose of the study is to determine whether or not 3 different doses of DAC HYP are effective in decreasing the number of abnormal spots (lesions) on brain magnetic resonance imaging (MRI) scans and in delaying the progression of MS, and to test the safety of DAC HYP in patients with relapsing-remitting MS. This is a double blind, parallel group study where subjects will receive either placebo, or Dac HYP 25mg, 100 mg or 200 mg every 4 weeks by subcutaneous injection for 52 weeks.
Interventions
Daclizumab HYP (high yield process) 25mg, 100mg or 200mg, administered by subcutaneous injection every 4 weeks, for a duration of 12 months.
Sponsors
Biogen Idec
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Diagnosed with relapsing-remitting multiple sclerosis (according to McDonald criteria #1-4, Section 22), with a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, and who either have experienced at least 1 relapse within the 12 months prior to randomization with a cranial MRI demonstrating lesion(s) consistent with MS or show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.
Exclusion criteria
1.Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS2. History of malignancy; however, subjects with a history of excised or treated basal cell carcinoma or fewer than 3 squamous sell carcinomas are eligible to participate in this study.3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.4. History of abnormal laboratory results that, in the opinion of the investigator, are indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than MS), and/or other major disease that would preclude administration of DAC HYP.5. History of human immunodeficiency virus (HIV) or other immunodeficient conditions.6. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.7. An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.8. Positive for hepatitis C virus (HCV) antibody and/or positive for hepatitis B surface antigen (HBsAg) at Screening.9. Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening.10. Exposure to varicella zoster virus within 21 days before Screening.11. Any of the following abnormal blood tests at Screening:i.Hemoglobin < or = 9.0 g/dLii.Platelets < or = 100 x 109/Liii.Lymphocytes < or = 1.0 x 109/Liv.Neutrophils < or = 1.5 x 109/L12. Any previous treatment with DAC HYP or Zenapax®.13. Any of the following types of live virus vaccine from 4 weeks before randomization: measles/mumps/rubella vaccine, varicella zoster virus vaccine, oral polio vaccine, and nasal influenza vaccine. Use of these vaccines, however, by other members of the subject’s household does not affect the eligibility of patients to enroll or continue in the study.14. Infection (viral, fungal, bacterial) requiring hospitalization or intravenous (IV) antibiotics within 8 weeks before randomization.15. Elective surgery performed from 2 weeks prior to randomization or scheduled through the end of the study.16. Prior treatment with the any of the following:· total lymphoid irradiation· cladribine· mitoxantrone· T-cell or T-cell receptor vaccination· any therapeutic monoclonal antibody, except natalizumab or rituximab17. Prior treatment with cyclophosphamide or rituximab within 1 year prior to randomization.18. Prior treatment with any of the following medications or procedures within the 6 months prior to randomization:· natalizumab· cyclosporine· azathioprine· methotrexate· intravenous immunoglobulin (IVIg)· plasmapheresis or cytapheresis19. Prior treatment with any of the following within the 3 months prior to randomization:·SC or oral glatiramer acetate·IFN-alpha·IFN-beta (subjects who are positive for neutralizing antibodies to IFN beta may receive IFN-beta treatment up to 2 weeks prior to randomization)20. Treatment with any of the following medications within the 30 days prior to randomization:·IV corticosteroid treatment·oral corticosteroid treatment·4-aminopyridine or related products21. Female subjects considering becoming pregnant while in the study.22. Female subjects who are currently pregnant or breastfeeding.23. Previous participation in this study.24. Subjects, for whom MRI is contraindicated, i.e., have pacemakers or other contraindicated implanted metal devices, are allergic to gadolinium, or have claustrophobia that cannot be medically managed.25. Current enrollment in any other investigational drug study or participation in any other investigational study within 6 months prior to randomization.26.Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s ability to comply with the protocol.27. Other unspecified reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment.
Outcome results
None listed