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

A Pilot Multi-Center, Open-Label, Assessor Blinded, Prospective Profiling Study in MS Subjects Treated With AVONEX®, MS Subjects Naïve to Treatment, and Healthy Control Subjects

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00913666

Enrollment

121

Registered

2009-06-04

Start date

2002-11-30

Completion date

2004-11-30

Last updated

2009-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis

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.

Interventions

DRUGInterferon beta-1a (Avonex)

30 mcg by intramuscular injection once a week

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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. Other inclusion and

Design outcomes

Primary

Measure	Time frame
Changes in bioanalytical measures after receiving therapy for 3 to 6 months	Study duration is 6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026