NCT01628315

Brief Summary

  • To examine short- and long-term value of appearance of new active lesions in predicting extent of cortical and subcortical deep gray matter (SDGM) atrophy over 5 years in ASA (Avonex- Steroid-Azathioprine)study.
  • To explore how accumulation of cortical and SDGM atrophy over 5 years differs with respect to the number of new active lesions or amount of disease activity, in early relapsing-remitting multiple sclerosis (RRMS) patients who did or did not develop sustained disability progression.
  • To examine the relationship between development of cortical and SDGM atrophy and regional likelihood of development of new active lesions over 5 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 26, 2012

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

Same day

First QC Date

May 1, 2012

Last Update Submit

February 11, 2016

Conditions

Multiple Sclerosis, Relapsing-remitting

Keywords

Multiple SclerosisASAMRILesion activity

Outcome Measures

Primary Outcomes (1)

  • Lesion Activity

    Assessment of lesion activity in the 0-6 and 6-12 months in the ASA study will allow the classification of patients with respect to the number of new active lesions over short-term (over 1 year) in order to examine predictive value of MRI disease activity in relation to development of long-term (5 year) cortical and SDGM atrophy.

    5 years

Study Arms (1)

Mulitple Sclerosis

Patients with relapsing-remitting MS who had a MRI as part of their participation in the ASA study.

Device: MRI

Interventions

MRIDEVICE

Annual MRIs as part of participation in the ASA study.

Mulitple Sclerosis

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

* Multiple Sclerosis, relapsing-remitting * Enrolled into the 2-year, double-blind, placebo-controlled ASA study

You may qualify if:

  • Enrolled into the 2-year, double-blind, placebo-controlled ASA study and entered 3 year extension study
  • MRI was performed on all patients using a 1.5 T magnet

You may not qualify if:

  • MRI images unable to be processed
  • All 5 MRI time points not collected

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buffalo Neuroimaging Analysis Center

Buffalo, New York, 14203, United States

Location

Related Publications (4)

  • Horakova D, Dwyer MG, Havrdova E, Cox JL, Dolezal O, Bergsland N, Rimes B, Seidl Z, Vaneckova M, Zivadinov R. Gray matter atrophy and disability progression in patients with early relapsing-remitting multiple sclerosis: a 5-year longitudinal study. J Neurol Sci. 2009 Jul 15;282(1-2):112-9. doi: 10.1016/j.jns.2008.12.005. Epub 2009 Jan 24.

    PMID: 19168190BACKGROUND

  • Horakova D, Cox JL, Havrdova E, Hussein S, Dolezal O, Cookfair D, Dwyer MG, Seidl Z, Bergsland N, Vaneckova M, Zivadinov R. Evolution of different MRI measures in patients with active relapsing-remitting multiple sclerosis over 2 and 5 years: a case-control study. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):407-14. doi: 10.1136/jnnp.2007.120378. Epub 2007 Jun 5.

    PMID: 17550987BACKGROUND

  • Havrdova E, Zivadinov R, Krasensky J, Dwyer MG, Novakova I, Dolezal O, Ticha V, Dusek L, Houzvickova E, Cox JL, Bergsland N, Hussein S, Svobodnik A, Seidl Z, Vaneckova M, Horakova D. Randomized study of interferon beta-1a, low-dose azathioprine, and low-dose corticosteroids in multiple sclerosis. Mult Scler. 2009 Aug;15(8):965-76. doi: 10.1177/1352458509105229. Epub 2009 May 22.

    PMID: 19465443BACKGROUND

  • Bergsland N, Horakova D, Dwyer MG, Dolezal O, Seidl ZK, Vaneckova M, Krasensky J, Havrdova E, Zivadinov R. Subcortical and cortical gray matter atrophy in a large sample of patients with clinically isolated syndrome and early relapsing-remitting multiple sclerosis. AJNR Am J Neuroradiol. 2012 Sep;33(8):1573-8. doi: 10.3174/ajnr.A3086. Epub 2012 Apr 12.

    PMID: 22499842BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Robert Zivadinov, MD,PhD,FAAN

    Buffalo Neuroimaging Analysis Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 1, 2012

First Posted

June 26, 2012

Study Start

March 1, 2009

Primary Completion

March 1, 2009

Study Completion

December 1, 2014

Last Updated

February 12, 2016

Record last verified: 2016-02

Locations

US(1)