Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
Brief Summary: This open-label, rater-blinded extension study enrolled participants who had relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior Genzyme-sponsored studies of alemtuzumab (CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\] also known as CARE-MS I, or CAMMS324 \[NCT00548405\] also known as CARE-MS II). The purposes of this study were:

1. To examine the long term safety and efficacy of alemtuzumab treatment in participants who received alemtuzumab as their study treatment in one of the prior studies.
2. To examine the safety and efficacy of initial alemtuzumab treatment in this study for participants who received Rebif® (interferon beta-1a) as their study treatment in one of the prior studies.
3. To determine the safety and efficacy of additional "as needed" alemtuzumab treatment courses. This applied both to participants who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.


Options:
A: Inclusion Criteria:

* Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
* At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening)
* Neurologic stability for greater than or equal to (\>=) 30 days prior to both screening and baseline
* Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive

Exclusion Criteria:

* Primary progressive multiple sclerosis
* Disease duration of more than 10 years in participants with EDSS less than or equal to (\<=) 2.0 at screening
* Contraindications for MRI
* Known presence of other neurological disorders which may mimic multiple sclerosis
* Pregnancy or lactation
* Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
* History of or currently active primary or secondary immunodeficiency
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Active infection, or history of or known presence of recurrent or chronic infection (e.g., hepatitis B or C, human immunodeficiency virus \[HIV\], syphilis, tuberculosis)
* History of progressive multifocal leukoencephalopathy
* Contraindications to or intolerance of oral or iv corticosteroids
* Contraindications to Rebif or incompatibility with Rebif use
B: Inclusion Criteria:

* 1.Received alemtuzumab in CAMMS323 or CAMMS324, completed the 2-year study period, and had not subsequently received disease modifying treatments (other than glatiramer acetate or interferon beta); or
* 2.Received Rebif® in CAMMS323 or CAMMS324, completed the 2-year study period, and had not subsequently received alternative disease modifying treatments (other than glatiramer acetate or another interferon beta); or
* 3.Participated in CAMMS223.
* NOTE: Criteria 1 and 2 above meant that participants who enrolled in CAMMS323 or CAMMS324 but did not complete the 2-year study period or went on to receive non-study drug DMTs after randomization were not eligible for inclusion in the Extension Study. Participants who enrolled in CAMMS324 after participation in CAMMS223 must meet criteria 1 or 2 to be eligible for inclusion in the Extension Study.

Exclusion Criteria:

* Any alemtuzumab participant from CAMMS223, CAMMS323, or CAMMS324 who had received alemtuzumab off-label (ie, outside of one of the prior Genzyme-sponsored studies), or was participating in any other investigational study, unless approved by Genzyme. In addition, these participants must be screened for disqualifying safety concerns before receiving alemtuzumab retreatment.
* Any Rebif® participants from CAMMS223, CAMMS323, or CAMMS324 who met any of the following criteria. In addition, these participants must be screened for disqualifying safety concerns before receiving alemtuzumab treatment. a) Did not wish to receive alemtuzumab; b) Ongoing participation in any other investigational study, unless approved by Genzyme; c) Had received alemtuzumab off-label (ie, outside of one of the prior Genzyme-sponsored studies); d) Known bleeding disorder or therapeutic anticoagulation; e) Diagnosis of idiopathic thrombocytopenia purpura or other autoimmune hematologic abnormality; f) History of malignancy, except basal cell skin carcinoma; g) Intolerance of pulsed corticosteroids, especially a history of steroid psychosis h) Significant Autoimmune disorder (other than MS); i) Major psychiatric disorder or epileptic seizures not adequately controlled by treatment; j) Active infection or high risk for infection k) Unwilling to use a reliable and acceptable contraceptive method during and for at least 6 months following each alemtuzumab treatment cycle (fertile participants only).
C: Key inclusion Criteria:

* Diagnosis of Multiple Sclerosis (MS) as defined by revised McDonald criteria.
* A relapsing-remitting course of disease with at least 1 documented relapse during the previous year, or 2 documented relapses during the previous 2 years, or a positive gadolinium (Gd)-enhanced MRI scan at screening (in case the first MRI scan obtained at screening is negative, a second scan may be obtained 1 month later.)
* An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at randomization.
* Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization.
* Patients who decline initiation or continuation of treatment with available disease modifying drugs for MS, for whatever reason, after having been informed about their respective benefits and possible adverse events by the investigator.

Key exclusion Criteria:

* A manifestation of another type of MS than RRMS
* History of chronic disease of the immune system other than MS
* Malignancies, diabetes, significant cardiovascular, pulmonary and hepatic diseases and conditions
* Active infections
D: Inclusion Criteria

Patients may be eligible for this study if they:

* Have been diagnosed with RR-MS, within 2 years of diagnosis.
* Are 18-55 years old.
* Have RR-MS with evidence of demyelination on MRI scanning of the brain.
* Have extended disability status scale (EDSS) scores between 0 and 3.5.
* Have not taken Copaxone or oral myelin.
* Have not had immunomodulating therapy for the past 3 months.
* Have not taken immunosuppressants.
* Have not had steroid treatment 1 month before entry.
* Have no evidence of active infection or cancer.

Exclusion Criteria

Patients may not be eligible for this study if they:

* Have a normal brain MRI.
* Are not willing to practice contraception (applies to women who are able to have children).
* Are pregnant or breast-feeding.
* Are currently taking any of the following drugs: beta2-adrenergic agonist or antagonist, diuretics, tricyclic antidepressants, or monoamine oxidase inhibitors.
* Have heart, blood, liver, or kidney problems.
* Have a disease that affects blood clotting or lung function.
* Have abnormalities that relate to the endocrine system.
* Have a history of alcohol or drug abuse within 6 months of enrollment.
* Have been diagnosed with primary progressive MS, in which the disease slowly worsens without periods of recovery.

Answer: B