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Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy

NCT ID: NCT00493077

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

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2006-05-31

Brief Summary

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This study is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy in patients who have developed neutralizing antibodies during previous interferon-beta treatment

Detailed Description

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This is a multi-centre, prospective, open label, non-comparative phase IV trial. Eligible patients will receive treatment with IFN-beta-1a AVONEX® 30 mcg i.m. once weekly for 12 months.The patients will be examined clinically and NAb titres will be performed at screening and after 12 months. Adverse event source verification will be performed during the documentation period.

Conditions

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Multiple Sclerosis

Keywords

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Multiple Sclerosis Neutralizing antibodies Safety Low immunogenicity interferon interferon-beta-1a

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

low immunogenic interferon-beta-1a

Intervention Type DRUG

dosage and frequency as per Biogen Idec protocol

Interventions

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low immunogenic interferon-beta-1a

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 MS according to Poser criteria(CDMS or LSDMS)30 or MS according to McDonald criteria
* Disability equivalent to an EDSS of 6.0 or less at screening
* Neutralizing antibody titre \> 20 and \<500 in two consecutive NAb tests. One must be from before screening
* previous treatment with either subcutaneous administered interferon-b-1b (Betaferon®) or interferon-b-1a (Rebif TM) prior to enrolment
* A priori has been decided to be treated with AVONEX

Exclusion Criteria

* Is NAb positive on AVONEX
* History of major depression
* Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV), or significant 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
* 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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Research Site

Gothenburg, , Sweden

Site Status

Coordinating Research Site

Huddinge, , Sweden

Site Status

Research Site

Jönköping, , Sweden

Site Status

Research Site

Karlstad, , Sweden

Site Status

Research Site

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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SAFE

Identifier Type: -

Identifier Source: org_study_id