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

Biogen

Status and phase

Completed

Phase 4

Conditions

Relapsing-Remitting Multiple Sclerosis

Treatments

Drug: methylprednisolone

Drug: Interferon-beta-1a

Study type

Interventional

Funder types

Industry

Identifiers

NCT00493116

AUS-8001

Details and patient eligibility

About

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

Full description

This is an explorative multi-centre, open label, non-comparative trial investigating whether it is possible to recover IFN-beta efficacy in breakthrough relapsing-remitting multiple sclerosis patients with high titres of neutralizing IFN-beta antibodies.

Prior to enrollment, treated MS subjects must have been on interferon-beta-1a or interferon-beta-1b for a minimum of 12 months and have reduced bioavailability as defined by the relative expression of MxA mRNA/GAPDH.

Subjects will complete a washout period with concurrent methylprednisolone 500mg PO daily for 3 days every month until they become Neutralizing Antibody negative. Subjects will then be challenged with AVONEX 30mcg IM weekly. Bioavailability will be measured every three months to determine return of biological activity. Clinical and MRI parameters, safety and tolerability will be compared to baseline to determine efficacy.

Enrollment

20 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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