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Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies

NCT ID: NCT00492466

Last Updated: 2008-01-30

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2006-08-31

Brief Summary

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This study is to find out if Interferon-beta can recover its effectiveness in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta.

Detailed Description

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This is a multi-center, open Label, non-comparative Phase IV trial. Eligible Patients will receive treatment with Interferon-beta-1a (AVONEX) 30mcg I.M. once weekly for up to 12 months.

In the wash-out period prior to commencing treatment with AVONEX, patients will receive treatment with intermittent Methylprednisolone 500 mg PO Daily for three consecutive days at monthly intervals.

The patients will be examined clinically and laboratory tests will be performed at screening (month -1) and after 3, 9, and 15 months.

Neutralizing antibody(NAb)titres and Binding antibody(BAb)titres as well as MxA protein levels will be evaluated at screening/baseline (month -1/0) and after 3, 6, 9, 12, and 15 months.

Conditions

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Relapsing-Remitting Multiple Sclerosis

Keywords

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Multiple Sclerosis antibody Neutralizing antibody Binding antibody MxA protein

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 label

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 label

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

* Relapsing remitting Multiple Sclerosis according to Poser criteria (CDMS or LDMS) or Multiple Sclerosis according to McDonald criteria
* Disability equivalent to EDSS of 6.0 or less
* Clinical activity defined as at least one relapse rate within the last 12 months
* NAb titre \>20 (measured at least 48 hours after last interferon-beta injection
* has been treated with subcutaneously administered interferon-beta-1b or interferon-beta-1a (Rebif) for at least 24 hours before enrollment

Exclusion Criteria

* Any condition that might give rise to similar symptoms as MS
* Immunomodulatory therapy other than interferon-beta-1a or interferon-beta-1b or any immunosuppressive treatment six months prior to inclusion into the trial
* Treatment with glucocorticoids or ACTH less than one month prior to inclusion into the trial
* History of major depression
* Alcohol or drug dependency
* Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
* hypertension (BP \> 180/110 mmHg)
* Renal insufficiency defined as serum creatinine \> 1.5 times the upper normal reference limit
* Any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
* Gastro-intestinal ulcers, gastritis, or dyspepsia
* Women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. To avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives
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

Principal Investigators

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Biogen-Idec Investigator

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Coordinating Research Site

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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RECOVER

Identifier Type: -

Identifier Source: org_study_id