Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers
Phase 4
Completed
- Conditions
- Multiple Sclerosis
- Interventions
- Drug: Interferon beta-1a (Avonex)
- Registration Number
- NCT00913666
- Lead Sponsor
- Biogen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 Interferon beta-1a (Avonex) MS patients previously naïve to interferon therapy Group 3 Interferon beta-1a (Avonex) MS patients on Interferon beta-1a treatment with no history of breakthrough disease (clinically stable) Group 4 Interferon beta-1a (Avonex) MS patients on interferon beta-1a treatment with a history of breakthrough disease.
- Primary Outcome Measures
Name Time Method Changes in bioanalytical measures after receiving therapy for 3 to 6 months Study duration is 6 months
- Secondary Outcome Measures
Name Time Method