Evaluation of Brain Atrophy in CIS Patients on Avonex

July 8, 2014 updated by: Robert Zivadinov, MD, PhD, University at Buffalo

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)

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Multiple sclerosis patients being treated with Avonex after first clinical attack.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Can Avonex delay development of clinically definite MS?
Time Frame: 5
To examine whether Avonex can delay the development of clinically definite multiple sclerosis
5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Can Avonex delay disability progression?
Time Frame: 5
To investigate if Avonex can delay disability progression by slowing brain atrophy
5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University at Buffalo

Collaborators

Charles University, Czech Republic
Biogen
Jacobs Neurological Institute

Investigators

  • Principal Investigator: Robert Zivadinov, MD,PhD,FAAN, University at Buffalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

May 3, 2012

First Submitted That Met QC Criteria

May 4, 2012

First Posted (Estimate)

May 7, 2012

Study Record Updates

Last Update Posted (Estimate)

July 9, 2014

Last Update Submitted That Met QC Criteria

July 8, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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