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, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).


Options:
A: 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.
B: Inclusion Criteria:

* Be between 18 and 60 years of age
* Have definite relapsing multiple sclerosis
* Have had one or more relapses within the prior 12 months
* Must be in a clinically stable or improving neurological state during the four weeks prior to Study Day 1
* Expanded Disability Status Scale (EDSS) score from 0 to 5.5, inclusive
* If female, she must either be post-menopausal or surgically sterilized; or use a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and be neither pregnant nor breast-feeding
* Confirmation that the subject is not pregnant must be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days of Study Day 1 and a negative urine pregnancy test on Study Day 1. A pregnancy test is not required if the subject is post-menopausal or surgically sterilized
* Be willing and able to comply with the protocol for the duration of the study
* Voluntarily provide written informed consent and, for USA sites only, a subject authorization under Health Insurance Portability and Accountability Act (HIPAA), prior to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care

Exclusion Criteria:

* Have secondary progressive multiple sclerosis (SPMS) or primary progressive MS (PPMS)
* Prior use of any interferon or glatiramer acetate
* Have had treatment with oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within 4 weeks of Study Day 1 and within 7 days prior to the Day 1 magnetic resonance imaging (MRI)
* Have a psychiatric disorder that is unstable or would preclude safe participation in the study.
* Have significant leukopenia (white blood cell count \< 0.5 times the lower limit of normal of the central laboratory) within 7 days of Study Day 1.
* Have elevated liver function tests (alanine aminotransferase \[AST\], aspartate aminotransferase \[ALT\], alkaline phosphatase \> 2.0 times the upper limit of normal \[ULN\] of the central laboratory, or total bilirubin \> 1.5 times the ULN of the central laboratory) within 7 days of Study Day 1 or a history of hepatitis (including infectious or drug-induced)
* Prior cytokine or anti-cytokine therapy within 3 months prior to Study Day 1
* Prior use of immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone) within the 12 months prior to Study Day 1
* Prior use of cladribine or have received total lymphoid irradiation
* Have allergy or hypersensitivity to human serum albumin, mannitol, glatiramer acetate, natural or recombinant interferon-β, or any other components of the study drugs or gadolinium diethylenetriaminepentaacetic acid
* Have taken intravenous immunoglobulin or any other investigational drug or taken part in any experimental procedure in the 6 months prior to Study Day 1.
* Presence of systemic disease that might interfere with subject safety, compliance or evaluation of the condition under study (e.g. insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, human immunodeficiency virus \[HIV\], human T-cell lymphotrophic virus type I \[HTLV-1\])
* Have had plasma exchange in 3 months prior to Study Day 1.
C: Inclusion Criteria:

* Diagnosis of MS as defined by McDonald et al, criteria, # 1- 4
* Between the ages of 18 and 55, inclusive
* Baseline EDSS score between 0.0 and 5.0, inclusive
* Have been treated with Avonex for at least the 12 months prior to randomization
* Have experienced at least one relapse (while on Avonex) within the 12 months prior to randomization.
* Cranial MRI scan demonstrating lesions 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 within 50 days of randomization
* A clinically significant infectious illness within 30 days prior to randomization
* History of, or abnormal lab result, indicative of significant disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent or Avonex 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 at Screening Visit
D: Inclusion Criteria:

* Female and male patients
* Aged 18-55 years
* Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis), EDSS score of 0 to 5.0
* Treatment-naive to IFNB or Copaxone

Exclusion Criteria:

* Neurological progression at disease onset or between relapses
* Serious or acute heart diseases
* History of severe depression or suicide attempt
* Serious or acute liver, renal or bone marrow dysfunction
* Monoclonal gammopathy
* Known allergy to Gadolinium-DTPA, to IFNs (Interferons), to glatiramer acetate, to human albumin or to mannitol
* Pregnancy or lactation

Answer: C