Clinical trial NCT00599274: Study to Determine if Avonex and Rebif Work Comparably Well in Subjects With Relapsing Multiple Sclerosis
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Interferon beta 1a
Avonex
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2008-01-23
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: subjects with relapsing remitting Multiple Sclerosis taking AVONEX® or Rebif®.

Brief summary: 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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Worcester
country: United States
facility: Research Site
state: Massachusetts
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Edmonds
country: United States
facility: Research Site
state: Washington
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Woodville
country: Australia
facility: Coordinating Research Site
city: Linz
country: Austria
facility: Coordinating Research Site
city: Halifax
country: Canada
facility: Coordinating Research Site
state: Nova Scotia
Study officials:
affiliation: Biogen
name: Biogen-Idec Investigator
role: PRINCIPAL_INVESTIGATOR
References: