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

NCT02076841 | Completed

• 1 other identifier: CHE-AVX-12-10348
• Study Type: observational
• Target: 40
• Locations: 2 countries
• Sites: 11

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• Quality of Life as assessed by the change in Short Form (SF) Health Survey, SF-36 scores

  Up to 12 months

• The percentage of missed injections

  Up to 12 months

Study Arms (1)

interferon beta-1a

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

Device: interferon beta-1a

Interventions

interferon beta-1a DEVICE

Administered as specified in the treatment arm

Also known as: BG9418, Avonex Pen, Avonex

interferon beta-1a

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Recruitment by participating clinicians in Switzerland and Czech Republic.

You may qualify if:

• Continuous treatment with Rebif, Betaferon or Copaxone over at least the past year.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (11)

Research Site

Brno, Czechia

Location

Research Site

Hradec Králové, Czechia

Location

Research Site

Jihlava, Czechia

Location

Research Site

Pilsen, Czechia

Location

Research Site

Prague, Czechia

Location

Research Site

Teplice, Czechia

Location

Research Site

Biel/Bienne, Switzerland

Location

Research Site

Langenthal, Switzerland

Location

Research Site

Lugano, Switzerland

Location

Research Site

Sion, Switzerland

Location

Research Site

Wil, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: March 4, 2014
• Study Start: July 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

CZ (6); CH (5)