The purpose of this study is to determine the effect of 2 different doses of daclizumab on reducing relapses in subjects with relapsing-remitting MS.
- Conditions
- Health Condition 1: null- Relapsing Remitting Multiple Sclerosis (RRMS)
- Registration Number
- CTRI/2010/091/000773
- Lead Sponsor
- Biogen Idec
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 600
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.
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
?
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Annualised relapse rateTimepoint: Week 52
- Secondary Outcome Measures
Name Time Method a. Brain MRI measures (number of gd enhancing lesions, number of new or newly enlarging T2 hyperintense lesions<br><br>b. Proportion of relapsing subjects<br><br>c. Improving quality of lifeTimepoint: Week 52