Assessing Tolerability of Avonex Intramuscular Injections

Trinity Health Of New England

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Drug: Avonex

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01641120

11-12-002

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

30 gauge

Experimental group

Description:

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

Treatment:

Drug: Avonex

25 gauge

Experimental group

Description:

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

Treatment:

Drug: Avonex