NCT00599274

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2002

Shorter than P25 for all trials

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2008

Completed
Last Updated

January 27, 2010

Status Verified

January 1, 2010

First QC Date

January 11, 2008

Last Update Submit

January 26, 2010

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisInterferon beta 1aAvonex

Study Arms (2)

A

This group was treated with Avonex once a week

Drug: Interferon beta-1a

B

This group was treated with Rebif three times a week

Drug: Interferon beta-1a

Interventions

Interferon beta-1aDRUG

injection once a week

Also known as: Avonex
A

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Los Angeles, California, United States

Location

Research Site

Walnut Creek, California, United States

Location

Research Site

Shreveport, Louisiana, United States

Location

Research Site

Worcester, Massachusetts, United States

Location

Research Site

Charlotte, North Carolina, United States

Location

Research Site

Columbus, Ohio, United States

Location

Research Site

Edmonds, Washington, United States

Location

Research Site

Milwaukee, Wisconsin, United States

Location

Coordinating Research Site

Woodville, Australia

Location

Coordinating Research Site

Linz, Austria

Location

Coordinating Research Site

Halifax, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Biogen-Idec Investigator

    Biogen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 11, 2008

First Posted

January 23, 2008

Study Start

August 1, 2002

Study Completion

May 1, 2003

Last Updated

January 27, 2010

Record last verified: 2010-01

Locations

US(8)CA(1)AU(1)