CompletedPhase 4Relapsing MSNCT00168766ISRCTN68218781

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Methylprednisolone

    Glucocorticoid receptor agonist

  • Interferon beta-1a

    Interferon alpha/beta receptor agonist

What it measured

Main measures

  • To estimate the effect interferon-beta-1a in combination with methylprednisolone vs interferon-beta-1a in combination with placebo on the time to onset of disability progression sustained over at least 6 months based on change from randomization in EDSS

    4 years

    Disability progressionImmune response

Other measures (1)

  • Not provided at time of registration

Who could take part

Relapsing MS · 18 to 55

Inclusion Criteria: * Informed consent * Relapsing remitting MS according to Poser criteria or McDonell criteria and naïve to therapy * Disability EDSS score of 4.0 or less at baseline * Clinical activity as defined by at least one relapse in the last year Exclusion Criteria: * Relapse in the month prior to enrolment * Treatment with immunosuppressive drugs for MS * History of major depression * Former severe reactions to corticosteroids * Pregnant women * Diabetes mellitus, and drug or alcohol dependency * Known or suspected allergy to trial products

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

About this trial

In the sponsor's words

The primary objective of this study is to determine whether combination treatment (adding methylprednisolone to Avonex) reduces progression of disability over 4 years compared to Avonex alone. The study will also investigate whether combination therapy has any impact on the incidence of relapse and brain atrophy as measured by MRI.

Papers

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Related trials

History

    1. Started

      Jan 2003

    2. Main results due

      Nov 2008

    3. Finished

      Nov 2008

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