Assessing Tolerability of Avonex Intramuscular Injections

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-02-28

Brief Summary

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The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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30 gauge

Subjects used a 30 gauge needle for intramuscular injection of Avonex.

Group Type EXPERIMENTAL

Avonex

Intervention Type DRUG

Intramuscular injection administered using 25 gauge or 30 gauge needle

25 gauge

Subjects used a 25 gauge needle for intramuscular injection of Avonex.

Group Type EXPERIMENTAL

Avonex

Intervention Type DRUG

Intramuscular injection administered using 25 gauge or 30 gauge needle

Interventions

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Avonex

Intramuscular injection administered using 25 gauge or 30 gauge needle

Intervention Type DRUG

Other Intervention Names

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Interferon beta-1a

Eligibility Criteria

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Inclusion Criteria

* Between 18 - 65 years of age;
* Confirmed diagnosis of Relapsing Remitting Multiple Sclerosis;
* Currently being treated with Avonex® for at least 90 days;
* Using 25 gauge needles for injection of Avonex® for at least 90 days;
* Willing and able to complete study questionnaires; and
* Provided informed consent to participate in this study

Exclusion Criteria

* Diagnosis of Progressive Multiple Sclerosis;
* History of recent illness or infection;
* History of allergic reaction to Avonex®;
* Any prior usage of a 30 gauge needle for administration of Avonex®;
* Concurrent treatment with other immunomodulating therapies;
* Pregnant or planning on becoming pregnant;
* Nursing mothers; and
* Unable to complete the requirements of the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No