Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS.


Options:
A: Inclusion Criteria:

* Male or female patients aged 18 to 55 years at Screening
* Diagnosis of multiple sclerosis (MS)
* Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) with disease activity
* Documentation of at least: 1 relapse during the previous 1 year OR 2 relapses during the previous 2 years OR a positive gadolinium-enhancing MRI scan during the year prior to randomization
* Disability status at Screening with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5
* Neurologically stable within 1 month prior to randomization

Exclusion Criteria:

* Patients with primary progressive MS or SPMS without disease activity
* Disease duration of more than 10 years in patients with an EDSS score of 2 or less
* Patients with an active chronic disease of the immune system other than MS
* Patients at risk of developing or having reactivation of hepatitis
* Patients with active systemic infections or with neurological findings consistent with PML
B: Key Inclusion Criteria:

* Must have a confirmed diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), and a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS
* Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive
* 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

Key Exclusion Criteria:

* Known intolerance, contraindication to, or history of non-compliance with Avonex® 30 µg
* History of treatment with Daclizumab High Yield Process (Dac HYP)
* History of malignancy
* History of severe allergic or anaphylactic reactions
* Known hypersensitivity to study drugs or their excipients
* History of abnormal laboratory results indicative of any significant disease
* History of human immunodeficiency virus (HIV) or other immunodeficient conditions
* History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization
* History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline
* History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1
* 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
* Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus
* Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening
* Exposure to varicella zoster virus within 21 days before screening

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
C: Inclusion Criteria:

* Diagnosis of MS, as defined by McDonald et al., criteria # 1-4 (McDonald et al., 2001)
* Between the ages of 18 and 50, inclusive.
* Baseline EDSS score between 0.0 and 5.0, inclusive.
* Have experienced at least one relapse within the 12 months prior to randomization.
* Cranial MRI scan demonstrating lesion(s) consistent with MS.
* Have given written informed consent to participate in the study.

Exclusion Criteria:

* Primary progressive, secondary progressive, or progressive relapsing MS.
* MS relapse has occurred,in the opinion of the investigator, within 50 days prior to randomization and/or the subject has not stabilized from a previous relapse.
* A clinically significant infectious illness within 30 days prior to randomization.
* History of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent for 116 weeks.
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
* Unable to perform the Timed 25-foot Walk, 9HPT, and PASAT 3.
* Abnormal blood tests performed at the Screening Visit.
D: Inclusion Criteria:

* Female or male patients with relapsing-remitting forms of multiple sclerosis (according to McDonald's criteria)
* Age between 18 and 60 years
* Natalizumab-treatment for at least 12 month following the current Swiss guidelines for treatment initiation
* Eligible patients are clinically stable (free from relapses and 6-month confirmed disability progression for at least 6 months) while on natalizumab-treatment
* Women of potential childbearing with active contraceptive methods
* Patients who are willing to undergo study procedures
* Patients who are willing and able to sign informed consent

Exclusion Criteria:

* Patients who have previously entered this study
* Natalizumab-treatment for less than 12 month following the current Swiss guidelines for treatment initiation
* Sign of clinical disease activity within the 6 month
* One or more relapses and/or 6-month confirmed disability progression during the 6 months prior to the study
* Any disease other than multiple sclerosis that would better explain the patient's signs and symptoms
* Secondary progressive MS
* Primary progressive MS
* Pregnancy - Urine pregnancy test at baseline visit - or breast feeding
* Uncontrolled, clinically significant heart diseases, such as arrhythmias, angina, or uncompensated congestive heart failure
* History of severe depression or attempted suicide or current suicidal ideation
* Medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol, or to complete the study
* Uncontrolled seizure disorder
* Myopathy or clinically significant liver disease
* Inability, in the opinion of the principal investigator or staff, to comply with protocol requirements for the duration of the study
* Known hypersensitivity to interferon-beta or other human proteins including albumin
* Any contraindication for MRI or contrast administration
* A history of drug abuse in the 6 months prior to screening
* Treatment with any of the following in the 30 days before day 1: systemic corticosteroids, ACTH, or other investigational drugs.
* Participation in any other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study
* Current participation on other clinical trials
* Treatment with drugs which might interfere with the evaluation of study drugs during the study protocol
* Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol

Answer: C