NCT00492466

Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies

A Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta Antibodies

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study is to find out if Interferon-beta can recover its effectiveness in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta.

Detailed description

This is a multi-center, open Label, non-comparative Phase IV trial. Eligible Patients will receive treatment with Interferon-beta-1a (AVONEX) 30mcg I.M. once weekly for up to 12 months. In the wash-out period prior to commencing treatment with AVONEX, patients will receive treatment with intermittent Methylprednisolone 500 mg PO Daily for three consecutive days at monthly intervals. The patients will be examined clinically and laboratory tests will be performed at screening (month -1) and after 3, 9, and 15 months. Neutralizing antibody(NAb)titres and Binding antibody(BAb)titres as well as MxA protein levels will be evaluated at screening/baseline (month -1/0) and after 3, 6, 9, 12, and 15 months.

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Interferon-beta-1a	dosage and frequency as per label
DRUG	methylprednisolone	dosage and frequency as per Biogen Idec protocol

Timeline

• Start date: 2003-03-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2007-06-27
• Last updated: 2008-01-30

Locations

1 site across 1 country: Finland