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CompletedNCT00913666Updated Jun 4, 2009

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

A Phase 4 interventional study of Interferon beta-1a (Avonex) in Multiple Sclerosis, sponsored by Biogen. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-06-04.

Sponsored by Biogen · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
121
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • Multiple Sclerosis
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 121 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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

05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
121 participants (actual)

Study arms

  • No intervention
    Group 1

    Healthy Volunteers

  • Experimental
    Group 2

    MS patients previously naïve to interferon therapy

    Drug: Interferon beta-1a (Avonex)

  • Experimental
    Group 3

    MS patients on Interferon beta-1a treatment with no history of breakthrough disease (clinically stable)

    Drug: Interferon beta-1a (Avonex)

  • Experimental
    Group 4

    MS patients on interferon beta-1a treatment with a history of breakthrough disease.

    Drug: Interferon beta-1a (Avonex)

Interventions

  • DrugInterferon beta-1a (Avonex)

    30 mcg by intramuscular injection once a week

    Also known as: Avonex

06

What researchers measure

Primary outcomes

  1. Changes in bioanalytical measures after receiving therapy for 3 to 6 months

    Time frame: Study duration is 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00913666
Lead sponsor
Biogen
First posted
Jun 4, 2009
Start date
Nov 2002
Completion
Nov 2004
Last update
Jun 4, 2009

Study contacts

Biogen-Idec Investigator
principal investigator · Biogen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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