Study to Determine if Avonex and Rebif Work Comparably Well in Subjects With Relapsing Multiple Sclerosis (PROOF)

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00599274
First received: January 11, 2008
Last updated: January 26, 2010
Last verified: January 2010
  Purpose

The purpose of this study is to find out if weekly Avonex works as well as three times a week Rebif in subjects with relapsing multiple sclerosis.


Condition Intervention
Multiple Sclerosis
Drug: Interferon beta-1a

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: A Multicenter, Prospective and Retrospective, Long-Term Observational Study of AVONEX® and Rebif® to Determine the Efficacy, Tolerability, and Safety in Subjects With Relapsing Multiple Sclerosis (MS)

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Enrollment: 136
Study Start Date: August 2002
Study Completion Date: May 2003
Groups/Cohorts Assigned Interventions
A
This group was treated with Avonex once a week
Drug: Interferon beta-1a
injection once a week
Other Name: Avonex
B
This group was treated with Rebif three times a week
Drug: Interferon beta-1a
injection three times a week
Other Name: Rebif

Detailed Description:

This is a Phase 4, multicenter, prospective and retrospective, long-term observational study of Avonex® and Rebif® to determine the efficacy, tolerability, and safety in subjects with relapsing MS.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

subjects with relapsing remitting Multiple Sclerosis taking AVONEX® or Rebif®.

Criteria

Inclusion Criteria:

  • Must have been receiving AVONEX® or Rebif®.
  • Must have a confirmed diagnosis of relapsing-remitting MS using the Poser criteria.
  • Must have experienced at least 2 relapses within the 3 year period prior to the initiation of treatment.
  • Must have an EDSS score of 0.0 to 5.5, inclusive.

Exclusion Criteria:

  • History of severe allergic or anaphylactic reaction or hypersensitivity to human albumin, to any interferon, or to other components of the drug formulation.
  • History of poorly controlled hypertension and/or other clinically significant major disease.
  • History of uncontrolled seizures within the 3 months prior to enrollment.
  • History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment.
  • Serious local infection or systemic infection within 8 weeks prior to enrollment.
  • Treatment with certain other agents to treat MS symptoms or underlying disease.
  • Treatment with any investigational product
  • Previous participation in this study.
  • Other Protocol-defined inclusion/exclusion criteria may apply.
  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: NCT00599274

Locations
United States, California
Research Site
Los Angeles, California, United States
Research Site
Walnut Creek, California, United States
United States, Louisiana
Research Site
Shreveport, Louisiana, United States
United States, Massachusetts
Research Site
Worcester, Massachusetts, United States
United States, North Carolina
Research Site
Charlotte, North Carolina, United States
United States, Ohio
Research Site
Columbus, Ohio, United States
United States, Washington
Research Site
Edmonds, Washington, United States
United States, Wisconsin
Research Site
Milwaukee, Wisconsin, United States
Australia
Coordinating Research Site
Woodville, Australia
Austria
Coordinating Research Site
Linz, Austria
Canada, Nova Scotia
Coordinating Research Site
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
Biogen Idec
Investigators
Principal Investigator: Biogen-Idec Investigator Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00599274     History of Changes
Other Study ID Numbers: C-862
Study First Received: January 11, 2008
Last Updated: January 26, 2010
Health Authority: United States: Food and Drug Administration
Austria: Ethikkommission
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada

Keywords provided by Biogen Idec:
Multiple Sclerosis
Interferon beta 1a
Avonex

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
Interferon beta 1a
Interferons
Interferon-beta
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014