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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913666
• Other study ID #: C-863
• Status: Completed
• Phase: Phase 4
• First received: June 2, 2009
• Last updated: June 3, 2009
• Start date: November 2002
• Est. completion date: November 2004

Study information

• Verified date: June 2009
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: November 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 exclusion criteria apply as per protocol

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon beta-1a (Avonex)
30 mcg by intramuscular injection 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	Changes in bioanalytical measures after receiving therapy for 3 to 6 months		Study duration is 6 months	No