Title
Assessing Tolerability of Avonex Intramuscular Injections
Assessing Tolerability of Avonex Intramuscular Injections With a 25 Gauge Needle Versus 30 Gauge Needle
Phase
N/ALead Sponsor
Saint Francis Hospital and Medical CenterStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Multiple SclerosisIntervention/Treatment
interferon beta-1b ...Study Participants
20The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.
Intramuscular injection administered using 25 gauge or 30 gauge needle
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
| Event Type | Organ System | Event Term |
|---|
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.
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 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.
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.
