Back to resultsAssessing Tolerability of Avonex Intramuscular Injections
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Avonex
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Intramuscular Injections, Relapsing Remitting
Eligibility Criteria
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
Sites / Locations
- The Mandell Center for Multiple Sclerosis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
30 gauge
25 gauge
Arm Description
Subjects used a 30 gauge needle for intramuscular injection of Avonex.
Subjects used a 25 gauge needle for intramuscular injection of Avonex.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01641120
First Posted
July 6, 2012
Last Updated
December 18, 2015
Sponsor
Trinity Health Of New England
Collaborators
Biogen
1. Study Identification
Unique Protocol Identification Number
NCT01641120
Brief Title
Assessing Tolerability of Avonex Intramuscular Injections
Official Title
Assessing Tolerability of Avonex Intramuscular Injections With a 25 Gauge Needle Versus 30 Gauge Needle
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trinity Health Of New England
Collaborators
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Intramuscular Injections, Relapsing Remitting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
30 gauge
Arm Type
Experimental
Arm Description
Subjects used a 30 gauge needle for intramuscular injection of Avonex.
Arm Title
25 gauge
Arm Type
Experimental
Arm Description
Subjects used a 25 gauge needle for intramuscular injection of Avonex.
Intervention Type
Drug
Intervention Name(s)
Avonex
Other Intervention Name(s)
Interferon beta-1a
Intervention Description
Intramuscular injection administered using 25 gauge or 30 gauge needle
Primary Outcome Measure Information:
Title
Change in Patient Visual Analog Scale Score for Pre-injection Anxiety
Description
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.
Time Frame
Weeks 2, 3, 4, 5
Title
Visual Analog Scale Score for Post-injection Pain
Description
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.
Time Frame
Weeks 2, 3, 4, 5
Secondary Outcome Measure Information:
Title
Fear of Injection
Description
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.
Time Frame
Weeks 2, 3, 4, 5
Title
Perception of Needle
Description
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.
Time Frame
Weeks 2, 3, 4, 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter B Wade, MD
Organizational Affiliation
Mandell Center for Multiple Sclerosis
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Mandell Center for Multiple Sclerosis
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessing Tolerability of Avonex Intramuscular Injections
We'll reach out to this number within 24 hrs