Overview

This trial is active, not recruiting.

Conditions relapsing-remitting multiple sclerosis, clinical isolated syndrome (cis), multiple sclerosis
Treatment interferon beta-1a
Sponsor Biogen
Start date July 2013
End date February 2016
Trial size 40 participants
Trial identifier NCT02076841, CHE-AVX-12-10348

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
30 μg intramuscularly once a week using an injection device (Avonex Pen).
interferon beta-1a BG9418
Administered as specified in the treatment arm

Primary Outcomes

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

Secondary Outcomes

Measure
Change from baseline to month 12 in injection site tolerability as measured on a composite VAS score
time frame: Up to 12 months
Change from baseline in the VAS score of systemic tolerability
time frame: Up to 12 months
The percentage of participants still on Avonex Pen
time frame: Up to 12 months
Quality of Life as assessed by the change in Short Form (SF) Health Survey, SF-36 scores
time frame: Up to 12 months
The percentage of missed injections
time frame: Up to 12 months
Change in Fatigue Scale for Motor and Cognitive functions (FSMC) score
time frame: Up to 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Key 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.

Additional Information

Official title Tolerability and Quality of Life in Patients With Multiple Sclerosis Switched to Intramuscular Interferon Beta 1a Autoinjector (Avonex® PenTM)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Biogen.