Tolerability and Quality of Life Study in Participants Who Switched to Avonex Pen

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

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-10-31

Brief Summary

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To evaluate treatment tolerability, adherence and quality of life (QoL) over 1 year in MS (Multiple Sclerosis) participants who have been switched - due to persistent tolerability issues, particularly injection problems - from a subcutaneous injectable disease-modifying treatment (DMT) given several times a week (Rebif, Betaferon or Copaxone) to once weekly Avonex 30 μg given intra-muscularly. Avonex will be applied by the injection device Avonex Pen.

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Detailed Description

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Conditions

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Relapsing-Remitting Multiple Sclerosis Clinical Isolated Syndrome (CIS) Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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interferon beta-1a

30 μg intramuscularly once a week using an injection device (Avonex Pen).

interferon beta-1a

Intervention Type DEVICE

Administered as specified in the treatment arm

Interventions

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interferon beta-1a

Administered as specified in the treatment arm

Intervention Type DEVICE

Other Intervention Names

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BG9418 Avonex Pen Avonex

Eligibility Criteria

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Inclusion Criteria

* Continuous treatment with Rebif, Betaferon or Copaxone over at least the past year.
* Injections site tolerability issues documented in medical records or by a nurse at inclusion.
* Clinically stable (free from relapses and 6-month confirmed disability progression for at least 6 months) while on therapy.
* Documented neurological history at least for the year prior to study entry.
* Qualification for Avonex® (Avonex Pen) according to the approved indication (Clinical Isolated Syndrome) or Relapsing Remitting Multiple Sclerosis (RRMS).
* Acceptance of magnetic resonance imaging.

Exclusion Criteria

* Patients who have previously entered this study.
* Treatment with Avonex during the 12 months prior to the study.
* One or more relapses and/or 6-month confirmed disability progression during the 6 months prior to the study.
* Patient on Betaferon with Neutralizing Antibodies (NAbs) more than 400 TRU (tenfold reduction units) and patients on Rebif with NAbs with more than 100 TRU.
* Secondary progressive multiple sclerosis.
* Primary progressive multiple sclerosis.
* Pregnancy or breast feeding.
* History of severe depression or attempted suicide or current suicidal ideation.
* Medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol, or to complete the study.
* Uncontrolled seizure disorder.
* Myopathy or clinically significant liver disease.
* Inability, in the opinion of the principal investigator or staff, to comply with protocol requirements for the duration of the study.
* Known hypersensitivity to interferon-beta or other human proteins including albumin.
* A history of drug abuse in the 6 months prior to screening.
* Treatment with any of the following in the 30 days before day 1: systemic corticosteroids, ACTH, or other investigational drugs.
* Participation in any other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study.
* Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No