Patients must meet all of the following criteria at the time of the baseline visit in order to enter the trial:

• Be Between 18 and 55 years of age, inclusive, at baseline.
• Be capable of giving, and have given written informed consent in English prior to any study related procedures. Spanish speaking patients who do not read English well can give written informed consent if a relative or friend fluent in both English and Spanish has translated the consent and any questions the patient may have.
• Be available and willing to complete all study assessments as specified in the protocol.

• Presently meet one of the two following forms of multiple sclerosis:

  1. Relapsing-remitting multiple sclerosis by McDonald’s criteria plus evidence of recent disease activity as shown by the development of one or more clinical and/or MRI lesions during the 6 months prior to entry into the study.

  2. A clinically isolated syndrome consistent with CNS demyelination confirmed on ophthalmologic or neurological examination with onset within 6 months prior to study entry. In addition, the following two criteria should be met: a- As evidence of dissemination in space, there should be two or more brain MRI lesions ≥ 3 mm in size at least one of which should be ovoid and/or periventricular in location; and b- As evidence of dissemination in time, if the CIS is acute (≤1 month) there should be one or more non-enhancing lesion or if the CIS is not acute (older than 1 month) the MRI should show one or more enhancing lesions.

     • At baseline, have an EDSS between 0-5.5, inclusive.
• Females of childbearing potential must agree to practice adequate contraception methods (IUCD, condoms, oral contraceptives, or other adequate barrier contraception) at baseline through 60 days after the last dose of trial drug. All females must have negative pregnancy test results (beta-HCG tests) at screening and a negative urine pregnancy test at baseline.
• Screening laboratory results that confirm adequate bone marrow, renal, and hepatic function as defined in the following table 1:

Table 1. Acceptable ranges for bone marrow, renal, and hepatic functions

· Bone Marrow Function Renal Function Hepatic Function Hemoglobin (HBO) ³9.0 gm/dl Serum creatinine £1.5 mg/dl Aminotransferases (ALT and AST) £2.5 times the upper limit of normal White blood cell count (WBC) ³2,500 and £15,000/mm3 Total bilirubin less than or equal to 1.75 mg/dL Absolute neutrophil count (ANC) ³750/mm3 Platelet count ³100,000/ mm3 Absolute lymphocyte count ³750/ mm3

7.3.2 Exclusion criteria

Patients were not permitted into the study if they met any of the following criteria:

• Onset of a relapse between screening and Study Day 1.
• Present evidence or history of any conditions that could affect the CNS or interfere with the MRI results or any other evaluation in the study.
• Possess any of the standard metallic devices or foreign bodies that are contraindications for MRI.
• Patient weight and or size unable to fit in the 3T MRI scanner.
• Pregnancy, as denoted by a positive serum pregnancy test (beta human chorionic gonadotropin [beta HCG]) at screening visit or a positive urine pregnancy test at the baseline visit. Subjects who are breast-feeding are also excluded.
• Have a known allergy or hypersensitivity to Gadolinium-chelates, human proteins including albumin and interferons, or Glatiramer Acetate or Mannitol.
• Uncontrolled, clinically significant heart diseases, such as dysrythmias, angina, or uncompensated congestive heart failure. History of or current unstable medical conditions that could be deemed clinically significant.
• Intolerance or any contraindication to acetaminophen, ibuprofen, or steroids.
• Inability, in the opinion of the principal investigator or staff, to be compliant with protocol requirements for the duration of the study.
• Participation in any clinical trial within the past six months
• History or present evidence of addictions.
• Have active peptic ulcer disease.
• Inability to administer subcutaneous injections either by self or by caregiver.
• Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study.
• Claustrophobia.
• Uncontrolled head movements.
• Treatment with any of the following in the indicated time frames:

Table 2. Prohibited treatments and washout periods

Washout Period Treatment(s) No use for at least one year before entry into the study · Any of the Interferons for > 6 months· Glatiramer acetate (Copaxone) for > 6 months.

No prior use allowed · Total lymphoid irradiation· Anti-lymphocyte monoclonal antibody (e.g. anti-CD4, anti-CD52 (Campath-1H) · Mitoxantrone,cyclophosphamide, Azathioprine, IVIG, cyclosporine A.

6 months before screening visit · Any investigational drug 21 days before screening visit · Systemic corticosteroids· ACTH Screening visit through Study Day 1 · Investigational drugs· Systemic corticosteroids· ACTH