Open-Label Safety Extension Study of Avonex

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00915460
• Other study ID #: C-98-838
• Status: Completed
• Phase: Phase 4
• First received: June 5, 2009
• Last updated: June 5, 2009
• Start date: September 1999
• Est. completion date: July 2003

Study information

• Verified date: June 2009
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: July 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon beta-1a (Avonex)
dosage and frequency as per Biogen Idec protocol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No