Evaluation of Brain Atrophy in CIS Patients on Avonex

NCT01592474 | Completed

• 1 other identifier: SET
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Avonex; Brain atrophy; MRI; Interferon-beta 1a; IFN Beta 1-a; Clinically isolated syndrome; CIS

Outcome Measures

Primary Outcomes (1)

• Can Avonex delay development of clinically definite MS?

  To examine whether Avonex can delay the development of clinically definite multiple sclerosis

  5

Secondary Outcomes (1)

• Can Avonex delay disability progression?

  5

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University at Buffalo: lead
• Biogen: collaborator
• Jacobs Neurological Institute: collaborator
• Charles University, Czech Republic: collaborator

Related Publications (1)

• Ravano V, Andelova M, Fartaria MJ, Mahdi MFA, Marechal B, Meuli R, Uher T, Krasensky J, Vaneckova M, Horakova D, Kober T, Richiardi J. Validating atlas-based lesion disconnectomics in multiple sclerosis: A retrospective multi-centric study. Neuroimage Clin. 2021;32:102817. doi: 10.1016/j.nicl.2021.102817. Epub 2021 Sep 2.

  PMID: 34500427 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Robert Zivadinov, MD,PhD,FAAN

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Buffalo Neuroimaging Analysis Center, Professor

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Study Start: October 1, 2005
• Primary Completion: August 1, 2011
• Study Completion: June 1, 2012
• Last Updated: July 9, 2014

Record last verified: 2014-07