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Completed

NCT Number: NCT01641120

Assessing Tolerability of Avonex Intramuscular Injections

The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Mandell Center for Multiple Sclerosis

Hartford, Connecticut, 06112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avonex

Drug

Intramuscular injection administered using 25 gauge or 30 gauge needle

Other names: Interferon beta-1a

Primary outcomes

  1. Change in Patient Visual Analog Scale Score for Pre-injection Anxiety

    Time frame: 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.

  2. Visual Analog Scale Score for Post-injection Pain

    Time frame: 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 outcomes

  1. Fear of Injection

    Time frame: 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.

  2. Perception of Needle

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Trinity Health Of New England

Other

Collaborators

  • Biogen

Registry information

Official study title

Assessing Tolerability of Avonex Intramuscular Injections With a 25 Gauge Needle Versus 30 Gauge Needle

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 16, 2012
Registry last updated
Feb 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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