Persistence, Adherence, Quality of Life, and Treatment Satisfaction With Avonex® PEN™.

NCT ID: NCT01405872

Last Updated: 2014-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-09-30

Brief Summary

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The primary objective of the study is to determine physician reported persistence with the Avonex PEN at Month 12/End of Study as well as determining factors associated with persistence. The secondary objectives for this study are as follows: To evaluate the tolerability for treatment administration of the Avonex PEN at Months 3, 6, and 12; To evaluate patient quality of life (QoL) while using the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate clarity of directions for use of the Avonex PEN at Month 3; To evaluate ease of use and the patient's assessment of the injection procedure with the Avonex PEN at Months 3, 6, and 12; To evaluate patient reported adherence at Months 6 and 12; To evaluate physician reported persistence at Month 6; To evaluate overall patient satisfaction with the use of the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate patient reported fear of injection at Months 3, 6, and 12; and To evaluate the percentage of patients switching from caregiver to self-injection at Months 3, 6, and 12.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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AVONEX PEN

Participants receive Avonex PEN commercially prescribed according to the local prescribing information.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent
* Must satisfy the locally approved therapeutic indications for the Avonex PEN
* Decision to treat with Avonex PEN must precede enrollment
* Must have no more than two (2) injections with the Avonex PEN prior to enrollment

Exclusion Criteria

* Inability to comply with study requirements
* Other unspecified reasons that, in the opinion of the investigator or Biogen Idec, make the patient unsuitable for enrollment
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Research Site

Glostrup Municipality, , Denmark

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Holstebro, , Denmark

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Næstved, , Denmark

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Amiens, , France

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Clermont-Ferrand, , France

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Créteil, , France

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Nancy, , France

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Rouen, , France

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Strasbourg, , France

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Aachen, , Germany

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Bamberg, , Germany

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Berlin, , Germany

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Dresden, , Germany

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Eisenach, , Germany

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Erbach im Odenwald, , Germany

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Freiburg im Breisgau, , Germany

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Hamburg, , Germany

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Heidenheim, , Germany

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Herford, , Germany

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Itzehoe, , Germany

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Kastellaun, , Germany

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München, , Germany

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Nagold, , Germany

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Potsdam, , Germany

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Regensburg, , Germany

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Rottweil, , Germany

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Rüdersdorf, , Germany

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Schwendi, , Germany

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Siegen, , Germany

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Sinsheim, , Germany

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Stade, , Germany

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Weil am Rhein, , Germany

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Weisbaden, , Germany

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Wolfratshausen, , Germany

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's-Hertogenbosch, , Netherlands

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Eindhoven, , Netherlands

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Heerlen, , Netherlands

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Leeuwarden, , Netherlands

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Sittard, , Netherlands

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Bergen, , Norway

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Drammem, , Norway

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Førde, , Norway

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Molde, , Norway

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Tønsberg, , Norway

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Amadora, , Portugal

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Košice, , Slovakia

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Helsingborg, , Sweden

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Karlstad, , Sweden

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Linköping, , Sweden

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Norrköping, , Sweden

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Skövde, , Sweden

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Stockholm, , Sweden

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Trollhättan, , Sweden

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Lucerne, , Switzerland

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Lugano, , Switzerland

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Sankt Gallen, , Switzerland

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Sion, , Switzerland

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Dundee, , United Kingdom

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Glasgow, , United Kingdom

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Hammersmith, , United Kingdom

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Haywards Heath, , United Kingdom

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Irvine, , United Kingdom

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Leicester, , United Kingdom

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Sheffield, , United Kingdom

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Countries

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Denmark France Germany Netherlands Norway Portugal Slovakia Sweden Switzerland United Kingdom

References

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Hupperts R, Becker V, Friedrich J, Gobbi C, Salgado AV, Sperling B, You X. Multiple sclerosis patients treated with intramuscular IFN-beta-1a autoinjector in a real-world setting: prospective evaluation of treatment persistence, adherence, quality of life and satisfaction. Expert Opin Drug Deliv. 2015 Jan;12(1):15-25. doi: 10.1517/17425247.2015.989209. Epub 2014 Nov 28.

Reference Type DERIVED
PMID: 25430947 (View on PubMed)

Other Identifiers

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108MS402

Identifier Type: -

Identifier Source: org_study_id

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