Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers

NCT ID: NCT00913666

Last Updated: 2009-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2004-11-30

Brief Summary

This study will look at differences in bioanalytical measures among different groups of MS patients and Healthy Volunteers, when administered interferon beta-1a.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Group 1

Healthy Volunteers

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group 2

MS patients previously naïve to interferon therapy

Group Type: EXPERIMENTAL

Interferon beta-1a (Avonex)

Intervention Type: DRUG

30 mcg by intramuscular injection once a week

Group 3

MS patients on Interferon beta-1a treatment with no history of breakthrough disease (clinically stable)

Group Type: EXPERIMENTAL

Interferon beta-1a (Avonex)

Intervention Type: DRUG

30 mcg by intramuscular injection once a week

Group 4

MS patients on interferon beta-1a treatment with a history of breakthrough disease.

Group Type: EXPERIMENTAL

Interferon beta-1a (Avonex)

Intervention Type: DRUG

30 mcg by intramuscular injection once a week

Interventions

Interferon beta-1a (Avonex)

30 mcg by intramuscular injection once a week

Intervention Type: DRUG

Other Intervention Names

Avonex

Eligibility Criteria

Inclusion Criteria

Healthy Control Subjects (Group 1)

• Must be in general good health.
• Must not have received interferons in the past.

All MS Subjects

• Clinical or laboratory-supported diagnosis of relapsing remitting MS (McDonald et al, criteria numbers 1-4).
• Either on AVONEX® or treatment-naïve.
• Have an EDSS score between 0.0 and 5.5, inclusive.

Exclusion Criteria

• History of severe allergic or anaphylactic reaction or hypersensitivity to human albumin, to any interferon, to other components of the drug formulation.
• History of intolerance to acetaminophen, ibuprofen, naproxen, and aspirin that would preclude the use of at least one of these during the study.
• History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease.
• History of malignancy.
• The presence of any significant medical condition or psychiatric illness not due to MS that, in the investigator's opinion, would interfere with therapy
• History of uncontrolled seizures within the 3 months prior to enrollment.
• History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment.
• Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 8 weeks prior to enrollment.
• Positive for human immunodeficiency virus (HIV), hepatitis C antibody (HCV) or positive for hepatitis B surface antigen (HbsAg) at screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Biogen Idec

Principal Investigators

Biogen-Idec Investigator

Role: PRINCIPAL_INVESTIGATOR

Biogen

Other Identifiers

C-863

Identifier Type: -

Identifier Source: org_study_id