Open-Label Safety Extension Study of Avonex

June 5, 2009 updated by: Biogen

An Open-Label Safety Extension Study of AVONEX® (Interferon Beta-1a) Treatment in Subjects Who Completed Biogen Studies C95-812, C96-823, or C97-830

To collect data on serious adverse events which occur during extended treatment with Avonex in subjects at high risk for developing multiple sclerosis (MS) and in subjects with secondary progressive MS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

408

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have completed (as defined below) one of the following Biogen AVONEX® clinical studies and meet the other criteria indicated.
  • Subjects enrolled from studies C95-812 and C97-830 must have completed their respective study within 12 months prior to enrollment in C98-838. Subjects enrolled from study C96-823 must have completed the study within 24 months prior to enrollment in C98-838.
  • have not been diagnosed with any other disease that accounts for their neurologic symptoms.

Exclusion Criteria:

  • History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta.
  • History of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin.
  • History of seizure within the 3 months prior to enrollment.
  • Abnormal laboratory results at the screening visit:
  • History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment into this study.

Other inclusion and exclusion criteria apply as per Biogen Idec Protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patients previously enrolled in BIogen Idec study C95-812.
Drug: Interferon beta-1a (Avonex)
dosage and frequency as per Biogen Idec protocol
Other Names:
  • Avonex
Experimental: 2
Patients previously enrolled in Biogen Idec study C96-823.
Drug: Interferon beta-1a (Avonex)
dosage and frequency as per Biogen Idec protocol
Other Names:
  • Avonex
Experimental: 3
Patients previously enrolled in Biogen Idec study C97-830.
Drug: Interferon beta-1a (Avonex)
dosage and frequency as per Biogen Idec protocol
Other Names:
  • Avonex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective of this study is to collect data on serious adverse events which occur during extended treatment with AVONEX in subjects at high risk for developing MS and in subjects with secondary progressive MS.
Time Frame: The study duration is 7 months
The study duration is 7 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To monitor the occurrence of diagnosed clinically definite multiple sclerosis (CDMS) in subjects who enter this study at high risk for developing MS following an initial demyelinating event.
Time Frame: The study duration is 7 months
The study duration is 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

July 1, 2003

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (Estimate)

June 8, 2009

Study Record Updates

Last Update Posted (Estimate)

June 8, 2009

Last Update Submitted That Met QC Criteria

June 5, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-98-838

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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