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Assessing Tolerability of Avonex Intramuscular Injections

This study is currently recruiting participants.
Verified April 2013 by Saint Francis Care
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
Saint Francis Care
ClinicalTrials.gov Identifier:
NCT01641120
First received: July 6, 2012
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  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 Injects With a 25 Gauge Needle Versus 30 Gauge Needle

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Saint Francis Care:

Primary Outcome Measures:
  • Change in patient VAS score [ Time Frame: baseline & 5 weeks ] [ Designated as safety issue: No ]
    The primary end point of the study will be a change in patient self reported Visual Analogue Scale (VAS) score for pre-injection anxiety and post-injection pain.


Secondary Outcome Measures:
  • Ease of use [ Time Frame: baseline & 5 weeks ] [ Designated as safety issue: No ]
    Secondary endpoint will be assessment of ease of use and fear of injection based on patient questionnaires completed prior to and after each injection. The patient will grade each statement on a grading scale which ranges from 0 (strongly agree) to 5 (strongly disagree).


Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 30 gauge
subjects will use 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 will use 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641120

Contacts
Contact: Claire Koenig 860-714-2149 CKoenig@stfranciscare.org

Locations
United States, Connecticut
The Mandell Center for Multiple Sclerosis Recruiting
Hartford, Connecticut, United States, 06112
Principal Investigator: Peter B. Wade, MD            
Sub-Investigator: Amy Neal, PA-C            
Sponsors and Collaborators
Saint Francis Care
Biogen Idec
Investigators
Principal Investigator: Peter B Wade, MD Mandell Center for Multiple Sclerosis
  More Information

No publications provided

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
Last Updated: April 10, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 18, 2013