NCT01641120

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 16, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
2 years until next milestone

Results Posted

Study results publicly available

February 1, 2016

Completed
Last Updated

February 1, 2016

Status Verified

December 1, 2015

Enrollment Period

1.8 years

First QC Date

July 6, 2012

Results QC Date

July 13, 2015

Last Update Submit

December 18, 2015

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisIntramuscular InjectionsRelapsing Remitting

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • Fear of Injection

    Weeks 2, 3, 4, 5

  • Perception of Needle

    Weeks 2, 3, 4, 5

Study Arms (2)

30 gauge

EXPERIMENTAL

Subjects used a 30 gauge needle for intramuscular injection of Avonex.

Drug: Avonex

25 gauge

EXPERIMENTAL

Subjects used a 25 gauge needle for intramuscular injection of Avonex.

Drug: Avonex

Interventions

AvonexDRUG

Intramuscular injection administered using 25 gauge or 30 gauge needle

Also known as: Interferon beta-1a
25 gauge30 gauge

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Mandell Center for Multiple Sclerosis

Hartford, Connecticut, 06112, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Lindsay Tuttle, MPH
Organization
Mandell Center for Multiple Sclerosis, Mount Sinai Rehabilitation Hospital
LTuttle@stfranciscare.org
860-714-2149

Study Officials

  • Peter B Wade, MD

    Mandell Center for Multiple Sclerosis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2012

First Posted

July 16, 2012

Study Start

May 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 1, 2016

Results First Posted

February 1, 2016

Record last verified: 2015-12

Locations

US(1)