Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had not previously received MS disease-modifying therapies. Participants had monthly laboratory tests and comprehensive testing every 3 months.


Options:
A: Inclusion Criteria:

- Diagnosis of RMS (as per McDonald criteria, 2005) Other protocol-defined inclusion criteria could apply.

Exclusion Criteria:

* Have primary progressive multiple sclerosis (MS)
* Have secondary progressive MS without superimposed relapses
* Relevant cardiac, hepatic and renal diseases as specified in the protocol
* Pretreatment with immunosuppressants and immunomodulating drugs as specified in the protocol
* Clinical significant abnormalities in blood cell counts and immunoglobulin levels as specified in the protocol
* Clinical significant acute or chronic infections as specified in the protocol Other protocol-defined exclusion criteria could apply.
B: Inclusion Criteria:

1. Must be 18 to 55 years old, inclusive, at the time of informed consent.
2. Must have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 (McDonald et al, 2001; Appendix 2).
3. Must have a baseline EDSS between 0.0 and 5.0, inclusive.
4. Must have experienced at least one relapse within the 12 months prior to randomization, with a prior cranial MRI demonstrating lesion(s) consistent with MS OR show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks.
5. Male and female subjects must be willing to take appropriate measures to prevent pregnancy.

Exclusion Criteria:

1. Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996 \[Appendix 3\]).
2. History of malignancy.
3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
4. History of abnormal laboratory results 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.
5. History of human immunodeficiency virus (HIV).
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. Body weight \>100 kg.
9. Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
10. Any of the following abnormal blood tests at screening.
11. Any previous treatment with FUMADERM®, FAG-201, or BG00012.
12. A medication history that precludes entry into the study.
13. Female subjects who are currently pregnant or breast-feeding.
C: Inclusion Criteria:

* Given written/signed informed consent
* Age 18 to 50 years old (inclusive) as of the date the informed consent form (ICF) was signed
* Diagnosis of MS per updated McDonald criteria, and cranial magnetic resonance imaging (MRI) scan demonstrating white matter lesions attributable to MS within 5 years of screening
* Onset of MS symptoms (as determined by a neurologist, either at screening or retrospectively) within 5 years of the date the ICF was signed
* Expanded Disability Status Scale (EDSS) score 0.0 to 3.0 (inclusive) at screening
* Greater than or equal to (\>=) 2 MS attacks (first episode or relapse) occurring in the 24 months prior to the date the ICF was signed, with \>=1 attack in the 12 months prior to the date the ICF was signed, with objective neurological signs confirmed by a physician, nurse practitioner, or other Genzyme-approved health-care provider and the objective signs could be identified retrospectively

Exclusion Criteria:

* Received prior therapy for MS other than corticosteroids, for example, alemtuzumab, interferons, intravenous immunoglobulin, glatiramer acetate, natalizumab, and mitoxantrone
* Exposure to azathioprine, cladribine, cyclophosphamide, cyclosporine A, methotrexate, or any other immunosuppressive agent other than systemic corticosteroid treatment
* Any progressive form of MS
* History of malignancy (except basal skin cell carcinoma)
* CD4 + , CD8 + count, B cell, or absolute neutrophil count less than (\<) lower limit of normal (LLN) at screening
* Known bleeding disorder (for example, dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, or clotting factor deficiency)
* Significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
* Presence of anti-thyroid stimulating hormone (TSH) receptor (TSHR) antibodies (that is, above the LLN)
* Active infection or at high risk for infection
D: Inclusion Criteria:

* Relapsing multiple sclerosis,
* Two relapses in prior 2 years or one relapse in prior year.

Exclusion Criteria:

* Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
* Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,
* Pregnant or nursing woman,
* Alcohol or drug abuse,
* Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,
* Human immunodeficiency virus (HIV) positive,
* Any known condition or circumstance that would prevent, in the investigator's opinion, compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Answer: C