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Persistence, Adherence, Quality of Life, and Treatment Satisfaction With Avonex® PEN™. (PERSIST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01405872
First received: July 28, 2011
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

The primary objective of the study is to determine physician reported persistence with the Avonex PEN at Month 12/End of Study as well as determining factors associated with persistence. The secondary objectives for this study are as follows: To evaluate the tolerability for treatment administration of the Avonex PEN at Months 3, 6, and 12; To evaluate patient quality of life (QoL) while using the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate clarity of directions for use of the Avonex PEN at Month 3; To evaluate ease of use and the patient's assessment of the injection procedure with the Avonex PEN at Months 3, 6, and 12; To evaluate patient reported adherence at Months 6 and 12; To evaluate physician reported persistence at Month 6; To evaluate overall patient satisfaction with the use of the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate patient reported fear of injection at Months 3, 6, and 12; and To evaluate the percentage of patients switching from caregiver to self-injection at Months 3, 6, and 12.


Condition Intervention
Multiple Sclerosis
Other: AVONEX PEN

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:


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 [ 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 [ 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 ]
  • Tolerability of Avonex PEN as measured by Injection Site Reaction [ Time Frame: Months 3, 6 and 12 ] [ Designated as safety issue: Yes ]
  • Ease of use and patient's assessment of the injection procedure with the Avonex PEN as measured by Patient Assessment of Injection Procedure [ Time Frame: Months 3, 6 and 12 ] [ Designated as safety issue: No ]

Enrollment: 270
Study Start Date: September 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: AVONEX PEN
    Participants receive Avonex PEN commercially prescribed according to the local prescribing information.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405872

  Show 64 Study Locations
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01405872     History of Changes
Other Study ID Numbers: 108MS402
Study First Received: July 28, 2011
Last Updated: September 5, 2014
Health Authority: Denmark: Danish Medicines Agency
Norway: Ethics Committee
Switzerland: Swissmedic
Portugal: Ethics Committee for Clinical Research
Sweden: Regional Ethical Review Board
Slovakia: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Interferon beta 1a
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014