Evaluation of Brain Atrophy in CIS Patients on Avonex

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Biogen Idec
Jacobs Neurological Institute
Department of Neurology and Center of Clinical Neuroscience and
Charles University, Czech Republic
of Medicine, Prague, Czech Republic
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo
ClinicalTrials.gov Identifier:
NCT01592474
First received: May 3, 2012
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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
Multiple Sclerosis

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University at Buffalo:

Enrollment: 180
Study Start Date: October 2005
Estimated Study Completion Date: June 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592474

Sponsors and Collaborators
University at Buffalo
Biogen Idec
Jacobs Neurological Institute
Department of Neurology and Center of Clinical Neuroscience and
Charles University, Czech Republic
of Medicine, Prague, Czech Republic
Investigators
Principal Investigator: Robert Zivadinov, MD,PhD,FAAN University at Buffalo
  More Information

No publications provided

Responsible Party: Robert Zivadinov, MD, PhD, Director, Buffalo Neuroimaging Analysis Center, Professor, University at Buffalo
ClinicalTrials.gov Identifier: NCT01592474     History of Changes
Other Study ID Numbers: SET
Study First Received: May 3, 2012
Last Updated: May 4, 2012
Health Authority: United States: Health Sciences Institutional Review Board
Czech Republic: International Ethics Committee
United States: Food and Drug Administration

Keywords provided by University at Buffalo:
Multiple Sclerosis
Avonex
Brain atrophy
MRI
Interferon-beta 1a
IFN Beta 1-a
Clinically isolated syndrome
CIS

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Atrophy
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 15, 2014