Multiple Sclerosis, Relapsing-remittingASANCT01628315
Assessment of Lesion Activity Analysis in the Avonex- Steroid Azathioprine (ASA) Study
An observational study of Multiple Sclerosis, Relapsing-remitting, run by University at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-remitting
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: * Multiple Sclerosis, relapsing-remitting * Enrolled into the 2-year, double-blind, placebo-controlled ASA study
Who may be able to join
- 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
Who cannot join
- MRI images unable to be processed
- All 5 MRI time points not collected
Trial locations and contacts
1 site in 1 country.
United States1 site
Buffalo Neuroimaging Analysis Center
Buffalo, New York, 14203
About this study
- 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.
Read the 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.
- Conditions
- Multiple Sclerosis, Relapsing-remitting
- Being tested
- MRI
- Keywords
- Multiple Sclerosis, ASA, MRI, Lesion activity
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Annual MRIs as part of participation in the ASA study.
| Study group | Role | What they receive |
|---|---|---|
| Mulitple Sclerosis | Patients with relapsing-remitting MS who had a MRI as part of their participation in the ASA study. Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startMar 2009
- Primary completionMar 2009
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-remittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic, General University Hospital, Prague
- Responsible party
- Principal investigator, Robert Zivadinov, MD, PhD, University at Buffalo
- Investigators
- Robert Zivadinov, MD,PhD,FAAN, Principal investigator, Buffalo Neuroimaging Analysis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628315
- Sponsor's protocol ID
- ASA
- Acronym
- ASA
- Status last verified
- Feb 2016
- First submitted
- 1 May 2012
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19168190Horakova 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.
PubMed 17550987Havrdova 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.
PubMed 19465443Bergsland 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.
PubMed 22499842
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Lesion Activity Analysis in the Avonex- Steroid Azathioprine (ASA) Study
- ClinicalTrials.gov ID
- NCT01628315
- Acronym / sponsor ID
- ASA / ASA
- Conditions
- Multiple Sclerosis, Relapsing-remitting
- Keywords
- Multiple Sclerosis, ASA, MRI, Lesion activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic, General University Hospital, Prague
- Study start
- Mar 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mulitple Sclerosis | – | Device: MRIPatients with relapsing-remitting MS who had a MRI as part of their participation in the ASA study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- * Multiple Sclerosis, relapsing-remitting * Enrolled into the 2-year, double-blind, placebo-controlled ASA study
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- MRI images unable to be processed
- All 5 MRI time points not collected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAnnual MRIs as part of participation in the ASA study. | Device | Mulitple Sclerosis |
Primary outcome
Lesion Activity
Time frame: 5 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- Background: PubMed 19168190Horakova 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.
- Background: PubMed 17550987Horakova 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.
- Background: PubMed 19465443Havrdova 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.
- Background: PubMed 22499842Bergsland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Zivadinov, MD,PhD,FAAN principal investigator
Buffalo Neuroimaging Analysis Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-remitting, run by University at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion Activity (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01628315, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.