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

June 3, 2009 updated by: Biogen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group 1
Healthy Volunteers
Experimental: Group 2
MS patients previously naïve to interferon therapy
Drug: Interferon beta-1a (Avonex)
30 mcg by intramuscular injection once a week
Other Names:
  • Avonex
Experimental: Group 3
MS patients on Interferon beta-1a treatment with no history of breakthrough disease (clinically stable)
Drug: Interferon beta-1a (Avonex)
30 mcg by intramuscular injection once a week
Other Names:
  • Avonex
Experimental: Group 4
MS patients on interferon beta-1a treatment with a history of breakthrough disease.
Drug: Interferon beta-1a (Avonex)
30 mcg by intramuscular injection once a week
Other Names:
  • Avonex

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Principal Investigator: Biogen-Idec Investigator, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

June 4, 2009

Last Update Submitted That Met QC Criteria

June 3, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-863

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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