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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 18, 2014