Immunogenicity and Safety Study of Serum-Free Avonex

Multiple Sclerosis Clinical Trial

Official title:

A Multicenter, Open-Label Immunogenicity and Safety Study of a Serum-Free Pre-Formulated Solution of AVONEX (Interferon Beta-1a) Administered Intramuscularly to Patients With Relapsing/Remitting Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912860
• Other study ID #: C-867
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2009
• Last updated: June 5, 2009
• Start date: January 2003
• Est. completion date: January 2005

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 evaluate the immunogenicity of a serum-free pre-formulated solution of Avonex when given to interferon beta naive patients with relapsing/remitting multiple sclerosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: January 2005
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Must have a diagnosis of relapsing/remitting MS as defined by McDonald, et al15; criteria numbers 1-4.

• Must have an expanded disability status scale (EDSS) score between 0 and 5.5, inclusive.

• Must be able to understand and comply with the protocol.

Exclusion Criteria:

• Has experienced a relapse within 2 months prior to Day 1. Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 48 hours, and accompanied by new objective neurological findings upon examination by the investigator.

• History of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease that would preclude therapy with interferon beta.

• Abnormal screening or baseline blood tests determined to be clinically significant by the investigator

• History of a seizure within 3 months prior to Day 1.

• History of suicidal ideation within 3 months prior to Day 1 or an episode of severe depression within 3 months prior to Day 1.

• Known allergy to natural rubber latex.

Other inclusion and exclusion criteria apply as per protocol

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon beta-1a
serum free Avonex given IM once a week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the immunogenicity of a serum-free pre-formulated solution of AVONEX®		Study duration is 20 months	Yes
Secondary	To evaluate the safety of a serum-free pre-formulated solution of AVONEX®		The study duration is 20 months	Yes