Status:
COMPLETED
Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study will look at differences in bioanalytical measures among different groups of MS patients and Healthy Volunteers, when administered interferon beta-1a.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00913666
Start Date
November 1 2002
End Date
November 1 2004
Last Update
June 4 2009
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