Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers
This study will look at differences in bioanalytical measures among different groups of MS patients and Healthy Volunteers, when administered interferon beta-1a.
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
Outcomes
Primary Outcomes
Changes in bioanalytical measures after receiving therapy for 3 to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
NCT00913666 - Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers | Crick | Crick