Health Condition 1: null- Relapsing Remitting Multiple Sclerosis (RRMS)
Conditions
Interventions
Intervention1: Daclizumab HYP: 300mg SC Inj. every 4wk
Intervention2: Daclizumab HYP: 150mg SC Inj. every 4wk
Control Intervention1: Placebo: to match
Sponsors
Biogen Idec
Eligibility
Inclusion criteria
Inclusion criteria: MS subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline EDSS between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria: a. Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial MRI demonstrating lesion(s) consistent with MS , OR b. Show evidence of gadolinium-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.
Exclusion criteria
Exclusion criteria: Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of randomization: Medical History 1. Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined Lublin and Reingold, 1996 [Section 23]). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Patients with these conditions may also have superimposed relapses, but are distinguished from relapsing-remitting patients by the lack of clinically stable periods or clinical improvement. 2. 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 screening for active infection with Hepatitis B virus or Hepatitis C virus. 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: ? Hemoglobin ≤9.0 g/dL ? Platelets ≤100 × 109/L ? Lymphocytes ≤1.0 × 109/L ? Neutrophils ≤1.5 × 109/L ? alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase >2 times the upper limit of normal (ULN) ? serum creatinine >ULN. Treatment History 12. 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 subjects 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 rituximab. 17. 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 ?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualised relapse rateTimepoint: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Brain MRI measures (number of gd enhancing lesions, number of new or newly enlarging T2 hyperintense lesions b. Proportion of relapsing subjects c. Improving quality of lifeTimepoint: Week 52 | — |
Countries
India
Contacts
Public ContactNitya Pandita
Biogen Idec Biotech India Pvt. Ltd.
Outcome results
None listed