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

Multiple Sclerosis Clinical Trial

— SFERA  

Official title:

Tolerability and Quality of Life in Patients With Multiple Sclerosis Switched to Intramuscular Interferon Beta 1a Autoinjector (Avonex® PenTM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076841
• Other study ID #: CHE-AVX-12-10348
• Status: Completed
• Phase: N/A
• First received: February 19, 2014
• Last updated: January 26, 2017
• Start date: July 2013
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• interferon beta-1a
Administered as specified in the treatment arm

Locations

Country	Name	City	State
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Hradec Králové
Czech Republic	Research Site	Jihlava
Czech Republic	Research Site	Plzen
Czech Republic	Research Site	Praha
Czech Republic	Research Site	Teplice
Switzerland	Research Site	Bienne
Switzerland	Research Site	Langenthal
Switzerland	Research Site	Lugano
Switzerland	Research Site	Sion
Switzerland	Research Site	Wil

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Czech Republic,  Switzerland, 

Outcome

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