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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00913666
First received: June 2, 2009
Last updated: June 3, 2009
Last verified: June 2009
  Purpose

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


Condition Intervention Phase
Multiple Sclerosis
Drug: Interferon beta-1a (Avonex)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Changes in bioanalytical measures after receiving therapy for 3 to 6 months [ Time Frame: Study duration is 6 months ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: November 2002
Study Completion Date: November 2004
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Avonex

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Other inclusion and exclusion criteria apply as per protocol

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913666

Sponsors and Collaborators
Biogen Idec
Investigators
Principal Investigator: Biogen-Idec Investigator Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00913666     History of Changes
Other Study ID Numbers: C-863
Study First Received: June 2, 2009
Last Updated: June 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Biogen Idec:
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 23, 2014