Multiple SclerosisNCT01592474
Evaluation of Brain Atrophy in CIS Patients on Avonex
An observational study of Multiple Sclerosis, run by University at Buffalo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Jun 2012
- 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 patients being treated with Avonex after first clinical attack.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
About this study
Official title: Evolution of Gray Matter Atrophy Over 4 Years in Observational Study of Early IFNβ-1a I.M. Treatment in High Risk Subjects After Clinically Isolated Syndrome (SET Substudy)
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.
Read the detailed description
- Multiple sclerosis (MS) is a chronic inflammatory disorder characterized by focal areas of demyelination in the central nervous system (CNS). MRI findings suggest that we should look at gray matter atrophy as a marker of the disease process in MS.
- Avonex is a proven effective disease-modifying treatment, which reduces total brain and GM atrophy and should be considered first-line therapy in patients with RRMS and CIS.
- The original SET study is an open-label observational study of high risk subjects after CIS for development of CDMS that will enroll 220 patients who have started Avonex immediately after their first clinical attack in Czech Republic, and are followed with clinical and MRI examinations for 4 years at 0, 6, 12, 24, 36 and 48 months. The clinical and MRI acquisition examinations of this study are conducted in Czech Republic.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Avonex, Brain atrophy, MRI, Interferon-beta 1a, IFN Beta 1-a, Clinically isolated syndrome, CIS
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Can Avonex delay development of clinically definite MS?
To examine whether Avonex can delay the development of clinically definite multiple sclerosis
Measured: 5
Secondary outcomes (1)
Can Avonex delay disability progression?
To investigate if Avonex can delay disability progression by slowing brain atrophy
Measured: 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startOct 2005
- Primary completionAug 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen, Jacobs Neurological Institute, Charles University, Czech Republic
- Responsible party
- Principal investigator, Robert Zivadinov, MD, PhD, University at Buffalo
- Investigators
- Robert Zivadinov, MD,PhD,FAAN, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592474
- Sponsor's protocol ID
- SET
- Status last verified
- Jul 2014
- First submitted
- 3 May 2012
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34500427
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Gray Matter Atrophy Over 4 Years in Observational Study of Early IFNβ-1a I.M. Treatment in High Risk Subjects After Clinically Isolated Syndrome (SET Substudy)
- ClinicalTrials.gov ID
- NCT01592474
- Acronym / sponsor ID
- SET
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Avonex, Brain atrophy, MRI, Interferon-beta 1a, IFN Beta 1-a, Clinically isolated syndrome, CIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Collaborators
- Biogen, Jacobs Neurological Institute, Charles University, Czech Republic
- Study start
- Oct 2005
- Primary completion
- Aug 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 May 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.
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.
Detailed description
- Multiple sclerosis (MS) is a chronic inflammatory disorder characterized by focal areas of demyelination in the central nervous system (CNS). MRI findings suggest that we should look at gray matter atrophy as a marker of the disease process in MS.
- Avonex is a proven effective disease-modifying treatment, which reduces total brain and GM atrophy and should be considered first-line therapy in patients with RRMS and CIS.
- The original SET study is an open-label observational study of high risk subjects after CIS for development of CDMS that will enroll 220 patients who have started Avonex immediately after their first clinical attack in Czech Republic, and are followed with clinical and MRI examinations for 4 years at 0, 6, 12, 24, 36 and 48 months. The clinical and MRI acquisition examinations of this study are conducted in Czech Republic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Multiple sclerosis patients being treated with Avonex after first clinical attack.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Can Avonex delay development of clinically definite MS?
Time frame: 5
To examine whether Avonex can delay the development of clinically definite multiple sclerosis
1 secondary outcome
Can Avonex delay disability progression?
Time frame: 5
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 9 Jul 2014.
- Derived from this study: PubMed 34500427Ravano 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.
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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
University at Buffalo
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University at Buffalo.
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 10 inclusion and 6 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 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Can Avonex delay development of clinically definite MS? (time frame: 5). 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 NCT01592474, which also lists 1 linked publication.
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 9 Jul 2014.