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Assessment of Lesion Activity Analysis in the Avonex- Steroid Azathioprine (ASA) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Charles University, Czech Republic
General University Hospital, Prague
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo
ClinicalTrials.gov Identifier:
NCT01628315
First received: May 1, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose
  • 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.

Condition Intervention
Multiple Sclerosis, Relapsing-remitting
Device: MRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of Lesion Activity Analysis in the Avonex- Steroid Azathioprine (ASA) Study

Resource links provided by NLM:


Further study details as provided by University at Buffalo:

Primary Outcome Measures:
  • Lesion Activity [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 159
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Mulitple Sclerosis
Patients with relapsing-remitting MS who had a MRI as part of their participation in the ASA study.
Device: MRI
Annual MRIs as part of participation in the ASA study.

Detailed Description:

Historically, MS has been classified as a disease predominantly affecting the white matter (WM) of the central nervous system. However, pathological changes in gray matter (GM) are increasingly recognized as an important component of the MS disease process. Advances in MRI have enabled detection of changes in GM morphology.

The ASA study was a placebo-controlled trial that evaluated efficacy of Avonex® alone and in combination with azathioprine (AZA) or AZA and corticosteroids as initial MS therapy in 181 patients with early RRMS over 5 years. The study was conducted in the Czech Republic, and all clinical and MRI examinations were concluded at 5 years.

No study has evaluated the evolution of cortical and SDGM atrophy in relation to global or regional accumulation of active lesions and/or occurrence of relapses both from predictive short- and long-term perspective. The ASA study provides a unique opportunity to prospectively study the impact of cortical and SDGM atrophy accumulation on long-term disability progression in a defined cohort of early RRMS patients who presented with various amount of disease activity, as measured by the appearance of new active lesions and occurrence of relapses.

By assessing lesion activity in the 0-6 and 6-12 months in the ASA study we will be able to evaluate predictive value for development of cortical and SDGM atrophy in early RRMS patients over 5 years with respect to the number of new active lesions or amount of disease activity in the first year. We will also evaluate lesion development from 12-60 months in relation to development of cortical and SDGM atrophy. We will also analyze accumulation of cortical and SDGM atrophy in early RRMS patients who will or will not develop sustained disability progression, based on the number of new active lesions or amount of clinical and MRI disease activity in short- and long-term. Regional classification of new active lesions over 5 years in cortical, subcortical and fossa posterior will allow prospective examination of cortical and SDGM atrophy and appearance of the new lesions.

  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, relapsing-remitting
  • Enrolled into the 2-year, double-blind, placebo-controlled ASA study
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • MRI images unable to be processed
  • All 5 MRI time points not collected
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628315

Locations
United States, New York
Buffalo Neuroimaging Analysis Center
Buffalo, New York, United States, 14203
Sponsors and Collaborators
University at Buffalo
Charles University, Czech Republic
General University Hospital, Prague
Investigators
Principal Investigator: Robert Zivadinov, MD,PhD,FAAN Buffalo Neuroimaging Analysis Center
  More Information

Publications:
Responsible Party: Robert Zivadinov, MD, PhD, Director, Buffalo Neuroimaging Analysis Center, Professor, University at Buffalo
ClinicalTrials.gov Identifier: NCT01628315     History of Changes
Other Study ID Numbers: ASA
Study First Received: May 1, 2012
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University at Buffalo:
Multiple Sclerosis
ASA
MRI
Lesion activity

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Azathioprine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014