Assessing Tolerability of Avonex Intramuscular Injections

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Avonex

• Registration Number: NCT01641120
• Lead Sponsor: Trinity Health Of New England

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-16
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2015-07-13
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-18
• Last Update Submitted: 2015-12-18
• Results First Posted: 2016-02-01
• Last Update Posted: 2016-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
30 gauge	Avonex	Subjects used a 30 gauge needle for intramuscular injection of Avonex.
25 gauge	Avonex	Subjects used a 25 gauge needle for intramuscular injection of Avonex.

Primary Outcome Measures

Name	Time	Method
Change in Patient Visual Analog Scale Score for Pre-injection Anxiety	Weeks 2, 3, 4, 5	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.
Visual Analog Scale Score for Post-injection Pain	Weeks 2, 3, 4, 5	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.

Secondary Outcome Measures

Name	Time	Method
Fear of Injection	Weeks 2, 3, 4, 5	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.
Perception of Needle	Weeks 2, 3, 4, 5	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.

Trial Locations

Locations (1)

The Mandell Center for Multiple Sclerosis; 🇺🇸 Hartford, Connecticut, United States