Assessment of Lesion Activity Analysis in the Avonex- Steroid Azathioprine (ASA) Study
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | March 2009 |
| End Date: | December 2014 |
- 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.
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.
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.
(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.
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
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