A Multi-center, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Methylprednisolone in Combination with Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis

Completed

• Conditions: Relapsing Remitting Multiple Sclerosis (MS); Nervous System Diseases; Multiple sclerosis (MS)

• Registration Number: ISRCTN68218781
• Lead Sponsor: Biogen Idec

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04-01
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Current inclusion criteria as of 21/05/2008:
1. Informed consent
2. Relapsing remitting MS according to Poser criteria or McDonell criteria and naïve to therapy
3. Extended Disability Status Scale (EDSS) score of 4.0 or less at baseline
4. Clinical activity as defined by at least one relapse in the last year

Previous inclusion criteria:
Adult subjects aged 18-55 with relapsing remitting MS, previously untreated with immunomodulatory drugs.

Exclusion Criteria

Exclusion criteria added as of 21/05/2008:
1. Relapse in the month prior to enrolment
2. Treatment with immunosuppressive drugs for MS
3. History of major depression
4. Former severe reactions to corticosteroids
5. Pregnant women
6. Diabetes mellitus, and drug or alcohol dependency
7. Known or suspected allergy to trial products

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Added as of 21/05/2008:<br>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 randomisation in EDSS (Time Frame: 4 years)

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration