CompletedPhase 4Relapsing MSNCT00176592

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
The Primary Outcome Measure is the Number of "Combined Active Lesions" (CAL) by Monthly MRI at the Conclusion of the Study.Mean Difference (Final Values) 0.05<0.05

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Results by group

The Primary Outcome Measure is the Number of "Combined Active Lesions" (CAL) by Monthly MRI at the Conclusion of the Study.

up to 2 years

GroupValueIntervalNumber analysed
Betaseron0.63 Average number of lesions per scan2.76 (Standard Deviation)1688
Copaxone0.58 Average number of lesions per scan2.46 (Standard Deviation)1053

Betaseron

0.63

Copaxone

0.58

p = <0.05; Mean Difference (Final Values) 0.05

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Betaseron367 (19.4%)
Copaxone397 (17.9%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • The Primary Outcome Measure is the Number of "Combined Active Lesions" (CAL) by Monthly MRI at the Conclusion of the Study.

    up to 2 years

    MRI lesionsImmune response

Other measures (2)

  • The Number of Enhancing Lesions.

    up to 2 years

    MRI lesions
  • The Number of MRI Disease Free Patients.

    1 year

    MRI lesions

Who could take part

Relapsing MS · 18 to 55

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

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Related trials

History

    1. Started

      Jan 2003

    2. Main results due

      Jan 2007

    3. Finished

      Jan 2007

    4. Results posted

      Nov 2021

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