Efficacy and Safety of Daclizumab High Yield Process Versus Interferon β 1a in Patients With Relapsing-Remitting Multiple Sclerosis
- Conditions
- Health Condition 1: null- Relapsing Remitting Multiple Sclerosis
- Registration Number
- CTRI/2010/091/000254
- Lead Sponsor
- Biogen Idec Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1500
Inclusion Criteria
To be eligible for this study, candidates must meet the following
eligibility criteria prior to randomization or at the timepoint specified in
the individual criteria listed below:
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
2. Must be 18 to 55 years of age, inclusive, at the time of consent.
3. Must have a confirmed diagnosis of RRMS according to McDonald
criteria, numbers 1 through 4 (Polman et al, 2005), and a cranial
MRI demonstrating lesion(s) consistent with MS (it is not necessary to obtain a current scan if a scan performed previously is available; if a previous scan is not available, then the baseline scan may be used).
4. Must have a baseline EDSS between 0.0 and 5.0, inclusive.
5. Must meet one of the following disease activity-related criteria:
a) Two or more clinical relapses within the previous 3 years with
at least 1 clinical relapse in the 12 months prior to
randomization.
OR
b) One or more clinical relapses and 1 or more new MRI lesions
(Gd+ and/or T2 hyperintense lesion) within the previous 2 years
with at least one of these events in the 12 months prior to
randomization. The new MRI lesion must be distinct from one
associated with the clinical relapse. The baseline MRI may be
used to satisfy this criterion.
Note: For inclusion purposes, a clinical relapse is defined as neurologic
signs and/or symptoms documented in the medical record of at least 24
hours duration that are determined by the Investigator or the Treating
Neurologist as consistent with an MS relapse. Time since relapse should be
measured from the time of relapse onset. When inclusion is based on a new
MRI lesion, activity must be verified by the central MRI reading center.
6. Male subjects and female subjects of childbearing potential must be
willing to practice effective contraception during the study and be
willing and able to continue contraception for 4 months after their
last dose of study treatment.
Exclusion Criteria
Candidates will be excluded from study entry if any of the following
exclusion criteria exist at randomization or at the timepoint specified in the
individual criteria listed below:
Medical History
1. Diagnosis of primary progressive, secondary progressive, or
progressive relapsing MS (as defined by Lublin and Reingold,
2001). 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. Known intolerance, contraindication to, or history of non-compliance with Avonex 30 mcg.
Note: Current or prior use of an approved IFN β preparation for MS,
including Avonex, is allowed as long as the subject is currently appropriate
for Avonex treatment according to local prescribing information.
3. History of malignancy; however, subjects with a history of excised
or treated basal cell carcinoma or fewer than 3 squamous cell
carcinomas are eligible to participate in this study.
4. History of severe allergic or anaphylactic reactions.
5. Known hypersensitivity to study drugs or their excipients.
6. History of abnormal laboratory results that, in the opinion of the
Investigator, are indicative of any significant cardiac, endocrine,
hematological, hepatic, immunologic, metabolic, urologic,
pulmonary, gastrointestinal, dermatologic, psychiatric, renal,
neurological (other than MS), and/or other major disease that would
preclude administration of DAC HYP or Avonex.
7. History of human immunodeficiency virus (HIV) or other
immunodeficient conditions.
8. History of drug or alcohol abuse (as defined by the Investigator)
within the 2 years prior to randomization.
9. History of seizure disorder or unexplained blackouts OR history of
a seizure within 6 months prior to Baseline.
10. History of suicidal ideation or an episode of clinically severe
depression (as determined by the Investigator) within 3 months
prior to Day 1. Subjects receiving ongoing antidepressant therapy
will not be excluded from the study unless the medication has been
increased within the 6 months prior to Baseline.
11. 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.
12. Known history of, or positive screening test result for hepatitis C
virus or hepatitis B virus.
13. Varicella or herpes zoster virus infection or any severe viral
infection within 6 weeks before screening.
14. Exposure to varicella zoster virus within 21 days before screening.
15. Any of the following abnormal blood tests at screening:
? hemoglobin ≤9.0 g/dL
? platelets ≤100 x 109/L
? lymphocytes ≤1.0 x 109/L
? neutrophils ≤1.5 x 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
16. Any previous treatment with daclizumab or other anti-CD25
monoclonal antibody.
17. Any type of live virus vaccine from 4 weeks before randomization,
including but not limited to, measles/mumps/rubella vaccine,
varicella zoster virus vaccine, oral polio vaccine, and nasal
influenza vaccine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Annualized relapse rate (ARR)Timepoint: 96 weeks
- Secondary Outcome Measures
Name Time Method The secondary endpoints (rank ordered) for this study are: <br>1) Number of new or newly-enlarging T2 hyperintense lesions on brain MRI over 96 weeks <br>2) Change in Multiple Sclerosis Functional Composite (MSFC) score <br>3) Sustained disability progression defined by at least a 1.0-point increase on EDSS from baseline EDSS &#8805;1.0 that is sustained for 12 weeks or at least a 1.5-point increase on the EDSS from baseline EDSS <1.0 that is sustained for 12 weeks <br>4) Change in Multiple Sclerosis Impact Scale 29 (MSIS-29) physical score <br>5) The proportion of subjects who are relapse-freeTimepoint: 96 weeks