Open-Label Safety Extension Study of Avonex

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00915460

Enrollment

408

Registered

2009-06-08

Start date

1999-09-30

Completion date

2003-07-31

Last updated

2009-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

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

Brief summary

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.

Interventions

DRUGInterferon beta-1a (Avonex)

dosage and frequency as per Biogen Idec protocol

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

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.	The study duration is 7 months

Secondary

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.	The study duration is 7 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026