NCT00493077

Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy

A Swedish Multi-Centre, Prospective, Open Label Study: Safety of Avonex Treatment in Multiple Sclerosis Patients Who Are NAB Positive on Previous s.c Interferon Beta Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy in patients who have developed neutralizing antibodies during previous interferon-beta treatment

Detailed description

This is a multi-centre, prospective, open label, non-comparative phase IV trial. Eligible patients will receive treatment with IFN-beta-1a AVONEX® 30 mcg i.m. once weekly for 12 months.The patients will be examined clinically and NAb titres will be performed at screening and after 12 months. Adverse event source verification will be performed during the documentation period.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	low immunogenic interferon-beta-1a	dosage and frequency as per Biogen Idec protocol

Timeline

• Start date: 2004-05-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2007-06-27
• Last updated: 2008-01-30

Locations

5 sites across 1 country: Sweden