Combination Treatment of Relapsing-Remitting Multiple Sclerosis With Methylprednisolone and Interferon-Beta-1a

Condition(s) targeted: Multiple Sclerosis

Intervention: Methylprednisolone with interferon-beta-1a (Drug); Placebo with interferon-beta-1a (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Biogen Idec

Official(s) and/or principal investigator(s):
Biogen-Idec Investigator, Principal Investigator, Affiliation: Copenhagen, Denmark

Overall contact:
Biogen-Idec investigator, Email: neurologyclinicaltrials@biogenidec.com

This study is to find out if methylprednisolone in combination with Interferon-beta-1a improves the overall course and shortens relapses of Multiple Sclerosis.

Official title: A Multi-Centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-Beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Expanded Disability Status Scale (EDSS)progression of 1.0-1.5 or more

Secondary outcome:

Mean Changes in Multiple Sclerosis Functional Composite (MSFC) score

Number of Documented Relapses

Brain Atrophy as measured on MRI

Detailed description: This study is a Multi-centre, Double Blind,Randomized, Placebo controlled Parallel Group trial for the treatment of relapsing-remitting Multiple Sclerosis with a combination of Methylprednisolone and Interferon-beta-1a. The primary objective is to estimate the effect of these medications on the time to onset of disability or progression of Multiple Sclerosis. Mean Changes in the Multiple Sclerosis Functional Composite (MSFC) score, number of documented relapses, and Brain Atrophy on MRI will be followed in this study.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with Multiple Sclerosis according to McDonald criteria

- EDSS < or = to 4. 0

Exclusion Criteria:

- Relapse within 1 month of baseline

- previous treatment with Interferons of Glatiramer Acetate

- History of Major Depression

- Diabetes Mellitus

- Cardiac insufficiency

- women who are pregnant

- medical illness requiring treatment with systemic corticosteroids

Biogen-Idec investigator, Email: neurologyclinicaltrials@biogenidec.com

Coordinating Research Site, Copenhagen, Denmark; Recruiting
Biogen-Idec Investigator, Email: neurologyclinicaltrials@biogenidec.com
Biogen-Idec Investigator, Principal Investigator

Starting date: September 2002
Ending date: September 2007
Last updated: June 25, 2007