Assessing Tolerability of Avonex Intramuscular Injections

This study has been completed.
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Saint Francis Care
ClinicalTrials.gov Identifier:
NCT01641120
First received: July 6, 2012
Last updated: December 18, 2015
Last verified: December 2015
  Purpose
The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.

Condition Intervention
Multiple Sclerosis
Drug: Avonex

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Assessing Tolerability of Avonex Intramuscular Injections With a 25 Gauge Needle Versus 30 Gauge Needle

Resource links provided by NLM:


Further study details as provided by Saint Francis Care:

Primary Outcome Measures:
  • Change in Patient Visual Analog Scale Score for Pre-injection Anxiety [ Time Frame: Weeks 2, 3, 4, 5 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Weeks 2, 3, 4, 5 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Weeks 2, 3, 4, 5 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Weeks 2, 3, 4, 5 ] [ Designated as safety issue: No ]

    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.



Enrollment: 20
Study Start Date: May 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Interferon beta-1a

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641120

Locations
United States, Connecticut
The Mandell Center for Multiple Sclerosis
Hartford, Connecticut, United States, 06112
Sponsors and Collaborators
Saint Francis Care
Biogen
Investigators
Principal Investigator: Peter B Wade, MD Mandell Center for Multiple Sclerosis
  More Information

Responsible Party: Saint Francis Care
ClinicalTrials.gov Identifier: NCT01641120     History of Changes
Other Study ID Numbers: 11-12-002 
Study First Received: July 6, 2012
Results First Received: July 13, 2015
Last Updated: December 18, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Francis Care:
Multiple Sclerosis
Intramuscular Injections
Relapsing Remitting

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on August 30, 2016