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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00176592
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Stuart D Cook MD
• Public title: Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI BECOME
• Scientific title: Phase IV, Rater-blinded, Randomized Study, Comparing 250 mg of Betaseron With 20 mg of Copaxone in Patients With the Relapsing-remitting(RR) or CIS Forms of ms Using 3 Tesla(3T) Magnetic Resonance Imaging (MRI) With Triple-dose Gadolinium
• Date of first enrolment: January 2003
• Target sample size: 93
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00176592
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Stuart D Cook, MD
• Affiliation: MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Betaseron

Drug: Copaxone

Primary Outcome(s)

The primary outcome measure is the number of "combined active" lesions by monthly MRI at the conclusion of the study. [Time Frame: up to 2 years]

Secondary Outcome(s)

The number of "combined active" disease free patients. [Time Frame: up to 2 years]

The number of new lesions on long TR. [Time Frame: up to 2 years]

The number of enhancing lesions. [Time Frame: up to 2 years]

Secondary ID(s)

0120020167

Source(s) of Monetary Support

Please refer to primary and secondary sponsors