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

Information source: Biogen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing-Remitting Multiple Sclerosis

Intervention: Interferon-beta-1a (Drug); methylprednisolone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Biogen

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

Clinical Details

Official title: A Multi-Centre, Open Label Study to Investigate the Recovery of IFN-beta Efficacy in Relapsing-Remitting Multiple Sclerosis Patients With Neutralising IFN-beta Antibodies and Reduced Bioavailability

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: return of bioavailability of AVONEX (interferon-beta-1a) as measured by induction of MxA mRNA

Secondary outcome:

Proportion of patients becoming neutralizing antibody negative

proportion of patients becoming neutralizing antibody positive after treatment with AVONEX

proportion of patents relapse free

total relapses

proportion of patients with an increase in EDSS of 1 point

Brain atrophy and cumulative number of enlarging T2 lesions on MRI

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

Coordinating Research Site, NSW, Australia

Research Site, Hamilton, New Zealand

Additional Information

Starting date: October 2003
Last updated: September 12, 2013

Page last updated: August 20, 2015

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