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

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Interferon beta-1a (Drug); Interferon beta-1a (Drug)

Phase: N/A

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Biogen-Idec Investigator, Principal Investigator, Affiliation: Biogen

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.

Clinical Details

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 design: Observational Model: Case-Only

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

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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.

Locations and Contacts

Coordinating Research Site, Woodville, Australia

Coordinating Research Site, Linz, Austria

Research Site, Los Angeles, California, United States

Research Site, Walnut Creek, California, United States

Research Site, Shreveport, Louisiana, United States

Research Site, Worcester, Massachusetts, United States

Research Site, Charlotte, North Carolina, United States

Coordinating Research Site, Halifax, Nova Scotia, Canada

Research Site, Columbus, Ohio, United States

Research Site, Edmonds, Washington, United States

Research Site, Milwaukee, Wisconsin, United States

Additional Information

Starting date: August 2002
Last updated: January 26, 2010

Page last updated: August 23, 2015

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