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An Observational Study to Assess Persistence, Adherence, Quality of Life, and Treatment Satisfaction in Patients Beginning Therapy With the Avonex® PEN™ (PERSIST)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01405872
First received: July 28, 2011
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

An observational study to assess persistence, adherence, quality of life, and treatment satisfaction in patients beginning therapy with the Avonex® PEN™


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study to Assess Persistence, Adherence, Quality of Life, and Treatment Satisfaction in Patients Beginning Therapy With the Avonex® PEN™

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Persistence with Avonex PEN therapy at Month 12/End of Study as measured by the percentage of patients remaining on therapy at Month 12/End of Study as reported by a physician. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability of Avonex PEN as measured by Injection Site Pain & Injection Site Reaction [ Time Frame: Months 3, 6, and 12 ] [ Designated as safety issue: Yes ]
  • Patient Quality of Life as measured by the EuroQol 5 domain (EQ-5D) Questionnaire [ Time Frame: Months 3, 6, and 12 ] [ Designated as safety issue: No ]
  • Clarity of directions for use of the Avonex PEN as measured by the Avonex PEN Instruction & Grading Scale [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • Ease of use and patient's assessment of the injection procedure with the Avonex PEN as measured by Ease of Use Grading Scale & Patient Assessment of Injection Procedure [ Time Frame: Months 3, 6, and 12 ] [ Designated as safety issue: No ]
  • Patient reported adherence as measured by number of doses missed [ Time Frame: Over the first 6 months and during Months 6 & 12 ] [ Designated as safety issue: No ]
  • Physician reported persistence as measured by number of patients still on therapy [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Patient reported satisfaction with the Avonex PEN as measured by the Patient Satisfaction Questionnaire [ Time Frame: Months 3, 6 and 12 ] [ Designated as safety issue: No ]
  • Patient reported fear of injection using the Fear of Injection Scale [ Time Frame: Months 3, 6 and 12 ] [ Designated as safety issue: No ]
  • Percent of patients switching from caregiver to self injection [ Time Frame: Months 3, 6, and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: September 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Detailed Description:

This is a Phase 4 prospective, observational (non-interventional) study of approved and marketed intramuscular injection (IM) therapy to determine physician-reported persistence with the Avonex PEN at Month 12/End of Study as well as determining factors associated with persistence.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Multiple Sclerosis patients who have made the decision, along with their health care provider, to begin therapy with Avonex PEN.

Criteria

Inclusion Criteria:

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent
  • Must satisfy the locally approved therapeutic indications for the Avonex PEN
  • Decision to treat with Avonex PEN must precede enrollment
  • Must have no more than two (2) injections with the Avonex PEN prior to enrollment

Exclusion Criteria:

  • Inability to comply with study requirements
  • Other unspecified reasons that, in the opinion of the investigator or Biogen Idec, make the patient unsuitable for enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405872

Locations
Germany
Research Site
Berlin, Germany
Netherlands
Research Site
Sittard, Netherlands
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec Ltd.
ClinicalTrials.gov Identifier: NCT01405872     History of Changes
Other Study ID Numbers: 108MS402
Study First Received: July 28, 2011
Last Updated: September 13, 2012
Health Authority: Switzerland: Swissmedic
Austria: Agentur für Gesundheit und Ernärungssicherheit GmbH
Spain: Spanish Agency of Medicines
Czech Republic: State Institute for Drug Control
Australia: National Health and Medical Research Council
Brazil: Ministry of Health
Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013