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

NCT ID: NCT00493116

Last Updated: 2013-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2009-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Relapsing-Remitting Multiple Sclerosis

Keywords

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recovery of efficacy MxA protein neutralizing antibodies Multiple sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Interferon-beta-1a

Intervention Type DRUG

dosage and frequency as per Biogen Idec protocol

methylprednisolone

Intervention Type DRUG

dosage and frequency as per Biogen Idec protocol

Interventions

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Interferon-beta-1a

dosage and frequency as per Biogen Idec protocol

Intervention Type DRUG

methylprednisolone

dosage and frequency as per Biogen Idec protocol

Intervention Type DRUG

Other Intervention Names

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Avonex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Biogen Idec

Locations

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Coordinating Research Site

NSW, , Australia

Site Status

Research Site

Hamilton, , New Zealand

Site Status

Countries

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Australia New Zealand

Other Identifiers

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AUS-8001

Identifier Type: -

Identifier Source: org_study_id