Open-Label Safety Extension Study of Avonex - Full Text View

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Interferon beta-1a (Avonex)	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon Interferon beta Interferon beta-1a Avonex

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]


Enrollment:	408
Study Start Date:	September 1999
Study Completion Date:	July 2003
Primary Completion Date:	June 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: Avonex

Eligibility


Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

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: NCT00915460

Sponsors and Collaborators

Biogen Idec

Investigators


Study Director:	Biogen-Idec Investigator	Biogen Idec

More Information

No publications provided


Responsible Party:	Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier:	NCT00915460 History of Changes
Other Study ID Numbers:	C-98-838
Study First Received:	June 5, 2009
Last Updated:	June 5, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:


Multiple Sclerosis Avonex Interferon beta-1a patients at high risk to develop multiple sclerosis

Additional relevant MeSH terms:


Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Interferon beta 1a Interferon-beta	Interferons Adjuvants, Immunologic Anti-Infective Agents Antineoplastic Agents Antiviral Agents Immunologic Factors Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015