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Evaluation of Brain Atrophy in CIS Patients on Avonex

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ClinicalTrials.gov Identifier: NCT01592474
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : July 9, 2014
Sponsor:
Collaborators:
Biogen
Jacobs Neurological Institute
Charles University, Czech Republic
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo

Study Description
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Brief Summary:

The purpose of this study is

  • To examine if Avaonex can delay the development of clinically definite multiple sclerosis.
  • To investigate if Avonex can delay disability progression by slowing brain atrophy.

Condition or disease
Multiple Sclerosis

Detailed Description:
  • Multiple sclerosis (MS) is a chronic inflammatory disorder characterized by focal areas of demyelination in the central nervous system (CNS). MRI findings suggest that we should look at gray matter atrophy as a marker of the disease process in MS.
  • Avonex is a proven effective disease-modifying treatment, which reduces total brain and GM atrophy and should be considered first-line therapy in patients with RRMS and CIS.
  • The original SET study is an open-label observational study of high risk subjects after CIS for development of CDMS that will enroll 220 patients who have started Avonex immediately after their first clinical attack in Czech Republic, and are followed with clinical and MRI examinations for 4 years at 0, 6, 12, 24, 36 and 48 months. The clinical and MRI acquisition examinations of this study are conducted in Czech Republic.
Study Design
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Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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)
Study Start Date : October 2005
Actual Primary Completion Date : August 2011
Actual Study Completion Date : June 2012

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Can Avonex delay development of clinically definite MS? [ Time Frame: 5 ]
    To examine whether Avonex can delay the development of clinically definite multiple sclerosis


Secondary Outcome Measures :
  1. Can Avonex delay disability progression? [ Time Frame: 5 ]
    To investigate if Avonex can delay disability progression by slowing brain atrophy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Multiple sclerosis patients being treated with Avonex after first clinical attack.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592474


Sponsors and Collaborators
University at Buffalo
Biogen
Jacobs Neurological Institute
Charles University, Czech Republic
Investigators
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Principal Investigator: Robert Zivadinov, MD,PhD,FAAN University at Buffalo
More Information
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Responsible Party: Robert Zivadinov, MD, PhD, Director, Buffalo Neuroimaging Analysis Center, Professor, University at Buffalo
ClinicalTrials.gov Identifier: NCT01592474    
Other Study ID Numbers: SET
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014
Keywords provided by Robert Zivadinov, MD, PhD, University at Buffalo:
Multiple Sclerosis
Avonex
Brain atrophy
MRI
 Interferon-beta 1a
IFN Beta 1-a
Clinically isolated syndrome
CIS
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Atrophy
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathological Conditions, Anatomical