The purpose of this study is
- To examine if Avaonex can delay the development of clinically definite multiple
- To investigate if Avonex can delay disability progression by slowing brain atrophy.
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Full eligibility criteria for NCT01592474
Ages eligible for Study
18 Years to 55 Years
Genders eligible for Study
Accepts Healthy Volunteers
MRI findings must reveal at least 2 hyperintense lesions on T2-WI or FLAIR images at first clinical onset
CSF examination should confirm oligoclonal bands (examination must be done in an internationally approved lab and the CSF taken before the treatment of attack starts)
Age 18 - 55 years
Effective contraception in female patients of childbearing potential
Kurtzke EDSS ≤ 3.5 at baseline
Willingness to accept the plan of the study and compliance with the study
Time from the beginning of first symptoms of CIS to baseline visit should not exceed 4 months (baseline MRI and baseline visit will be organized first 28 days after last steroid administration)
CIS attack is treated by at least 3g of methylprednisolone without taper
In case of severe attack 1 g of cyclophosphamide does not disqualify the patient from the study if first MRI and CSF examination was done before treatment administered
No active major organ disease especially of hepatic or thyroid origin
The clinical diagnosis of MS is definite (the second attack occurs before the baseline visit)
Age less than 18 or more than 55
Non-effective contraception method or pregnancy planning
Active major organ disease, especially hepatic or endocrinologic
Cooperation of the subject cannot be ensured
Kurtzke EDSS higher than 3.5 at baseline
All locations for NCT01592474
View full eligibility
Tris trial is registered with FDA with number: NCT01592474. The sponsor of the trial is University at Buffalo and it is looking for 180 volunteers for the current phase.
Official trial title: Evolution of Gray Matter Atrophy Over 4 Years in Observational Study of Early IFNβ-1a I.M. Treatment in High Risk Subjects After Clinically Isolated Syndrome (SET Substudy)
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