Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers
