Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Betaseron; Copaxone
Intervention description: Betaseron 250 micrograms injected SQ every other day; Copaxone 20 mg injected SQ every day (glatiramer acetate)
Intervention MeSH terms: Glatiramer Acetate; Interferon beta-1b; (T,G)-A-L
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Brain; Betaseron; Copaxone; MRI

Summary:

      This is the first comparison of efficacy of Betaseron and Copaxone for treatment of relapsing
      forms of MS.
    

Eligibility criteria:

        Inclusion criteria:

        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, at baseline.

          -  Be capable of 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.

          -  Presently meet one of the two following forms of multiple sclerosis:

               1. Relapsing-remitting ms 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 CIS consistent with central nervous system (CNS) demyelination confirmed on
                  ophthalmologic or neurological examination with onset within 6 months prior to
                  study entry. Also:a- 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.

          -  Females of childbearing potential must agree to practice adequate contraception
             methods. All females must have negative pregnancy test results at screening and a
             negative urine pregnancy test at baseline.

          -  Screening laboratory results that confirm adequate bone marrow, renal, and hepatic
             function.

        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 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 dysrhythmias, 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 have subcutaneous injections administered.

          -  Medical, psychiatric or other conditions that compromise the patient's ability to
             understand the study procedures.

          -  Claustrophobia.

          -  Uncontrolled head movements.

          -  Treatment with any of the following in the indicated time frames: Any of the
             Interferons for > 6 months· Glatiramer acetate (Copaxone) for > 6 months.No prior use
             allowed of Total lymphoid irradiation, Anti-lymphocyte monoclonal antibody
             (e.g.(Campath-1H) .Mitoxantrone,cyclophosphamide, Azathioprine, intravenous
             immunoglobulin (IVIG), cyclosporine within 6 months before the screening visit·Any
             investigational drug 21 days before screening visit·Systemic corticosteroids·ACTH from
             screening visit through Study Day