Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to find out if Interferon-beta (IFN-beta) can recover its effectiveness after a washout period in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Antibodies; Immunoglobulins; Interferon beta-1a; Interferon-beta; Interferons; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Must have been receiving interferon-beta-1a or interferon-beta-1b for a minimum of 12 consecutive months prior to enrollment

• Relapsing-Remitting Multiple Sclerosis according to Poser or McDonald criteria

• EDSS score of 6 or less

• NAB titre >or equal to 20 via CPE assay or >or equal to 100 via MxA Protein assay measured at least 24 hours after last interferon-beta injection on two consecutive tests at least 3 months apart

• Reduced bioavailability (relative expression of MxA mRNA/GAPDH

Exclusion Criteria:

• History of severe allergic or anaphylactic reaction to human albumin, to any interferon, Methylprednisolone or to any other component of study drugs

• Clinically significant systemic illness

• History of poorly controlled hypertension, diabetes, or osteoporosis

• History of uncontrolled seizures within 3 months of enrollment

• History of Depression or suicidal ideation within 3 months of enrollment

• Serious local infection (abscess or cellulitis) or systemic infection within 8 weeks of study

• abnormal screening blood tests