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How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose

NCT ID: NCT00574041

Last Updated: 2008-09-04

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-02-29

Brief Summary

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This study is to find out if starting at low dose Avonex and slowly increasing to full dose will improve flu like symptoms as a side effect of Avonex treatment.

Detailed Description

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Conditions

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Relapsing Remitting Multiple Sclerosis

Keywords

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Multiple Sclerosis Avonex side effects flu like symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

titrated dose of Avonex

Group Type EXPERIMENTAL

Interferon beta-1a

Intervention Type DRUG

injected, once a week

2

full dose Avonex

Group Type ACTIVE_COMPARATOR

Interferon beta-1a

Intervention Type DRUG

injected, once a week

Interventions

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Interferon beta-1a

injected, once a week

Intervention Type DRUG

Other Intervention Names

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Avonex

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of clinically-definite relapsing-remitting multiple sclerosis

Exclusion Criteria

* Any Product Information-specified contraindications to interferon-beta therapy, or other medical factors which, in the opinion of the investigator, make the subject unsuitable for interferon-beta therapy
* Use of AVONEX, but not other interferon therapies, in the 3 months prior to randomisation into the study
* A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to randomisation.
* History of seizure in the 3 months prior to randomisation
* History of suicidal ideation or severe depression within the 3 months prior to randomisation.
Minimum Eligible Age

18 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

Biogen

Locations

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Coordinating Research Site

Malvern, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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AUS-8002

Identifier Type: -

Identifier Source: org_study_id