Assessing Tolerability of Avonex Intramuscular Injections

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

Official Title
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Assessing Tolerability of Avonex Intramuscular Injections With a 25 Gauge Needle Versus 30 Gauge Needle

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Avonex


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 30 gauge<br>Subjects used a 30 gauge needle for intramuscular injection of Avonex. | Drug: Avonex<br>* Intramuscular injection administered using 25 gauge or 30 gauge needle<br>* Other names: Interferon beta-1a;|
| Experimental: 25 gauge<br>Subjects used a 25 gauge needle for intramuscular injection of Avonex. | Drug: Avonex<br>* Intramuscular injection administered using 25 gauge or 30 gauge needle<br>* Other names: Interferon beta-1a;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Visual Analog Scale Score for Pre-injection Anxiety | The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for pre-injection anxiety. VAS scale (min=0- max=100 mm (10cm)) 0= no anxiety; 100 mm (10 cm)=very severe anxiety. Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size. Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size. | Weeks 2, 3, 4, 5 | 
| Visual Analog Scale Score for Post-injection Pain | The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for post-injection pain.VAS scale (min=0 - max=100 mm (10 cm)) 0= no pain; 100 mm (10 cm)=very severe pain. Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for post-injection pain for that needle size. Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for post-injection pain for that needle size. | Weeks 2, 3, 4, 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of Injection | Secondary endpoint was assessment of fear of injection based on patient questionnaires completed prior to each injection. The patient will respond to each statement on a scale which ranges from 1 (almost always) to 4 (almost never). Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes fear of injection for the 30 gauge needle. Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes fear of injection for the 25 gauge needle. | Weeks 2, 3, 4, 5 | 
| Perception of Needle | Secondary endpoint was assessment of the perception of the needle based on patient questionnaires completed after each injection. The patient will respond to each statement on a scale which ranges from 1 (strongly agree) to 5 (strongly disagree). A total of 6 statements were given to the participant the more strongly the participant agreed with the statement, the more favorably they perceived the needle. Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes perception of the 30 gauge needle. Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes perception of the 25 gauge needle. | Weeks 2, 3, 4, 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Intramuscular Injections, Relapsing Remitting