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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
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The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 gauge | Experimental | Subjects used a 30 gauge needle for intramuscular injection of Avonex. |
|
| 25 gauge | Experimental | Subjects used a 25 gauge needle for intramuscular injection of Avonex. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avonex | Drug | Intramuscular injection administered using 25 gauge or 30 gauge needle |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter B Wade, MD | Mandell Center for Multiple Sclerosis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Mandell Center for Multiple Sclerosis | Hartford | Connecticut | 06112 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 25 Gauge or 30 Gauge Needle | Avonex: Intramuscular injection administered using 25 gauge needle weeks 1, 4, and 5 and 30 gauge needle on weeks 2 and 3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 25 Gauge Needle Weeks 1, 4, 5 |
| |||||||||||||
| 30 Gauge Needle Weeks 2 and 3 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Avonex: Intramuscular injection administered using 30 gauge or 25 gauge needle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | cm | Weeks 2, 3, 4, 5 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 25 Gauge | The same subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lindsay Tuttle, MPH | Mandell Center for Multiple Sclerosis, Mount Sinai Rehabilitation Hospital | 860-714-2149 | LTuttle@stfranciscare.org |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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| 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | 30 Gauge | Subjects used a 30 gauge needle for intramuscular injection of Avonex for weeks 2 and 3 of the study. |
|
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Weeks 2, 3, 4, 5 |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | cm | Weeks 2, 3, 4, 5 |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Weeks 2, 3, 4, 5 |
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|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 30 Gauge | Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study. | 0 | 20 | 0 | 20 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |