Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Intramuscular Injections, Relapsing Remitting
Brief summary
The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.
Interventions
DRUGAvonex
Intramuscular injection administered using 25 gauge or 30 gauge needle
Sponsors
Biogen
Trinity Health Of New England
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Avonex: Intramuscular injection administered using 30 gauge or 25 gauge needle | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 10.41 |
| Race/Ethnicity, Customized Black | 3 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Race/Ethnicity, Customized White | 16 participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
Time frame: Weeks 2, 3, 4, 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 25 Gauge | Change in Patient Visual Analog Scale Score for Pre-injection Anxiety | 1.58 cm | Standard Deviation 2.25 |
| 30 Gauge | Change in Patient Visual Analog Scale Score for Pre-injection Anxiety | 2.22 cm | Standard Deviation 2.73 |
p-value: <0.05Wilcoxon Signed Ranks
Primary
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.
Time frame: Weeks 2, 3, 4, 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 25 Gauge | Visual Analog Scale Score for Post-injection Pain | 1.201 cm | Standard Deviation 1.22 |
| 30 Gauge | Visual Analog Scale Score for Post-injection Pain | 0.764 cm | Standard Deviation 0.93 |
p-value: 0.035Wilcoxon Signed Ranks
Secondary
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.
Time frame: Weeks 2, 3, 4, 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 25 Gauge | Fear of Injection | 1.38 units on a scale | Standard Deviation 0.509 |
| 30 Gauge | Fear of Injection | 1.41 units on a scale | Standard Deviation 0.558 |
p-value: 0.193Wilcoxon Signed Ranks
Secondary
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.
Time frame: Weeks 2, 3, 4, 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 25 Gauge | Perception of Needle | 2.58 units on a scale | Standard Deviation 0.914 |
| 30 Gauge | Perception of Needle | 1.94 units on a scale | Standard Deviation 0.853 |
p-value: 0.005Wilcoxon Signed Ranks