Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis
- Conditions
- G35Multiple sclerosis
- Registration Number
- DRKS00000438
- Lead Sponsor
- Biogen Idec
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1845
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 ß 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 10E9/L
•lymphocytes =1.0 x 10E9/L
•neutrophils =1.5 x 10E9/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.
18.Infection (viral, fungal, bacterial) requiring hospital
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary study objective is to test the superiority of DAC HYP compared to IFN ß-1a in preventing MS relapse in subjects with relapsing remitting MS (RRMS).<br>The primary analysis will include all relapses between the time of the first dosing and either the end of study or time of censoring. This analysis will include any relapses and time on study that occur up to Week 144.<br>
- Secondary Outcome Measures
Name Time Method