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

NCT00913666 | Completed Phase 4

• 1 other identifier: C-863
• Study Type: interventional
• Target: 121
• Locations: 0 countries
• Sites: N/A

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

Keywords

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Changes in bioanalytical measures after receiving therapy for 3 to 6 months

  Study duration is 6 months

Study Arms (4)

Group 1

NO INTERVENTION

Healthy Volunteers

Group 2

EXPERIMENTAL

MS patients previously naïve to interferon therapy

Drug: Interferon beta-1a (Avonex)

Group 3

EXPERIMENTAL

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

Drug: Interferon beta-1a (Avonex)

Group 4

EXPERIMENTAL

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

Drug: Interferon beta-1a (Avonex)

Interventions

Interferon beta-1a (Avonex) DRUG

30 mcg by intramuscular injection once a week

Also known as: Avonex

Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Biogen-Idec Investigator

  Biogen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 4, 2009
• Study Start: November 1, 2002
• Study Completion: November 1, 2004
• Last Updated: June 4, 2009

Record last verified: 2009-06