Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI

• Status: Unknown status
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stuart D Cook MD
• Treatments: (T,G)-A-L; Glatiramer Acetate; Interferon beta-1b

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