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Open-Label Safety Extension Study of Avonex

Information source: Biogen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

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

Phase: Phase 4

Status: Completed

Sponsored by: Biogen

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

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: 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.

Secondary outcome: 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: September 1999
Last updated: June 5, 2009

Page last updated: August 20, 2015

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