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

Completed

• Conditions: Relapsing-Remitting Multiple Sclerosis; Clinical Isolated Syndrome (CIS); Multiple Sclerosis
• Interventions: Device: interferon beta-1a

• Registration Number: NCT02076841
• Lead Sponsor: Biogen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-28
• Study First Posted: 2014-03-04
• Primary Completion: 2016-02
• Study Completion: 2016-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Key

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.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
interferon beta-1a	interferon beta-1a	30 μg intramuscularly once a week using an injection device (Avonex Pen).

Primary Outcome Measures

Name	Time	Method
Change from baseline to month 4 in injection site tolerability as measured on a composite visual analogue scale (VAS) score ranging from 0-100	Up to 4 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline to month 12 in injection site tolerability as measured on a composite VAS score	Up to 12 months
Change from baseline in the VAS score of systemic tolerability	Up to 12 months
The percentage of participants still on Avonex Pen	Up to 12 months
Change in Fatigue Scale for Motor and Cognitive functions (FSMC) score	Up to 12 months	Fatigue is rated using the self-administered FSMC questionnaire that includes ten questions that relate to motor fatigue and ten to cognitive fatigue. Higher scores indicate higher fatigue.
The percentage of missed injections	Up to 12 months
Quality of Life as assessed by the change in Short Form (SF) Health Survey, SF-36 scores	Up to 12 months	The SF-36 is a short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.

Trial Locations

Locations (1)

Research Site; 🇨🇭 Wil, Switzerland