Assessing Tolerability of Avonex Intramuscular Injections

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

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Avonex

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06112
      • The Mandell Center for Multiple Sclerosis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Saint Francis Care
• Collaborators: Biogen
• Investigators: Principal Investigator: Peter B Wade, MD, Mandell Center for Multiple Sclerosis

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: July 6, 2012
• First Submitted That Met QC Criteria: July 11, 2012
• First Posted (Estimate): July 16, 2012

Study Record Updates

• Last Update Posted (Estimate): February 1, 2016
• Last Update Submitted That Met QC Criteria: December 18, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Relapsing Remitting; Intramuscular Injections
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferons; Interferon beta-1a; Interferon-beta
• Other Study ID Numbers: 11-12-002