This study will look at differences in bioanalytical measures among different groups of MS
patients and Healthy Volunteers, when administered interferon beta-1a.
Drug: Interferon beta-1a (Avonex)
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Locations near you
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Full eligibility criteria for NCT00913666
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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
All locations for NCT00913666
View full eligibility
Tris trial is registered with FDA with number: NCT00913666. The sponsor of the trial is Biogen and it is looking for 121 volunteers for the current phase.
Official trial title: A Pilot Multi-Center, Open-Label, Assessor Blinded, Prospective Profiling Study in MS Subjects Treated With AVONEX®, MS Subjects Naïve to Treatment, and Healthy Control Subjects
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