Multiple SclerosisGASWINCT01695434
A Longitudinal Study of Effect of Copaxone in RRMS Over 24 Months
An observational study of Multiple Sclerosis, run by University at Buffalo at 1 site in United States.
Trial summary
To explore whether treatment with glatiramer acetate (GA) may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MRI
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Feb 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: MS patients from the Baird MS Center, The Jacobs Neurological Institute, Department of Neurology, State University at Buffalo, NY, USA who are also taking Copaxone as their disease modifying therapy. Healthy controls from the general population.
Who may be able to join
- MS patients diagnosed with clinically definite MS according to the McDonald criteria (Polman et al., 2005)
- Being on GA monotherapy (20mg/day sc) for at least 24 months prior to the 24-month MRI scan
- Having baseline clinical MRI scan that included SWI-filtered phase imaging in a 12-month window from the start day of the of the GA (MS patients)
- Having baseline clinical MRI scan that included SWI-filtered phase imaging (healthy controls)
- MS patients having a RR disease course (Lublin and Reingold, 1996)
- Age 18-65 (healthy controls will be matched to MS patients for age and sex)
Show all 11Show fewer
- Signed informed consent at the 24-month follow-up
- Pass MRI health screening
- MS patients passing contrast screening
- MS patients having normal kidney function (creatinine clearance >59)
- None of the exclusion criteria
Who cannot join
- Patients who had a relapse within 30 days prior to MRI baseline scan date
- Patients who received steroid treatment within 30 days prior to the MRI baseline scan date
- Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study
- MS patients who used other imunomodulatory or immunosuppressant treatment other than GA during the follow-up (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
- MS patients having abnormal kidney function (creatinine clearance <59)
Trial locations and contacts
1 site in 1 country.
United States1 site
Buffalo Neuroimaging Analysis Center
Buffalo, New York, 14203
About this study
Official title: A Prospective, Observational, Single-blinded, Longitudinal MRI Study of Effect of Glatiramer Acetate on Iron Deposition in Patients With Relapsing-remitting Multiple Sclerosis Over 24 Months
To explore whether treatment with glatiramer acetate (GA) may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls.
Read the detailed description
This is a prospective, observational, single-blinded, longitudinal, 24-month MRI study of the evolution of iron deposits, as evidenced by SWI-filtered phase imaging, in RRMS patients treated with GA and in healthy controls.
- Conditions
- Multiple Sclerosis
- Being tested
- MRI
- Keywords
- multiple sclerosis, MRI, Copaxone, healthy controls, glatiramer acetate
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
All subjects will undergo a MRI.
| Study group | Role | What they receive |
|---|---|---|
| Copaxone MRI | Patients with relapsing-remitting multiple sclerosis who take Copaxone will have a MRI. Receives: Other: MRI | |
| Healthy Controls MRI | Subjects who are otherwise healthy, without neurological disorders, will have a MRI. Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore whether treatment with GA may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls.
MRI collected from RRMS patients who have taken Copaxone for 24 months
Measured: 24 months
Secondary outcomes (1)
To investigate whether treatment with GA may decrease accumulation of iron in lesions, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months.
Evaluate if Copaxone will decrease iron in lesions.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Zivadinov, MD, PhD, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695434
- Sponsor's protocol ID
- GA-SWI 24
- Acronym
- GASWI
- Status last verified
- Mar 2013
- First submitted
- 26 Sep 2012
- Last updated
- 25 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Single-blinded, Longitudinal MRI Study of Effect of Glatiramer Acetate on Iron Deposition in Patients With Relapsing-remitting Multiple Sclerosis Over 24 Months
- ClinicalTrials.gov ID
- NCT01695434
- Acronym / sponsor ID
- GASWI / GA-SWI 24
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, MRI, Copaxone, healthy controls, glatiramer acetate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 28 Sep 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 explore whether treatment with glatiramer acetate (GA) may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls.
Detailed description
This is a prospective, observational, single-blinded, longitudinal, 24-month MRI study of the evolution of iron deposits, as evidenced by SWI-filtered phase imaging, in RRMS patients treated with GA and in healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Copaxone MRI | – | Other: MRIPatients with relapsing-remitting multiple sclerosis who take Copaxone will have a MRI. |
| Healthy Controls MRI | – | Other: MRISubjects who are otherwise healthy, without neurological disorders, will have a MRI. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- MS patients from the Baird MS Center, The Jacobs Neurological Institute, Department of Neurology, State University at Buffalo, NY, USA who are also taking Copaxone as their disease modifying therapy. Healthy controls from the general population.
Key inclusion criteria (11 listed)
- MS patients diagnosed with clinically definite MS according to the McDonald criteria (Polman et al., 2005)
- Being on GA monotherapy (20mg/day sc) for at least 24 months prior to the 24-month MRI scan
- Having baseline clinical MRI scan that included SWI-filtered phase imaging in a 12-month window from the start day of the of the GA (MS patients)
- Having baseline clinical MRI scan that included SWI-filtered phase imaging (healthy controls)
- MS patients having a RR disease course (Lublin and Reingold, 1996)
Key exclusion criteria (5 listed)
- Patients who had a relapse within 30 days prior to MRI baseline scan date
- Patients who received steroid treatment within 30 days prior to the MRI baseline scan date
- Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study
- MS patients who used other imunomodulatory or immunosuppressant treatment other than GA during the follow-up (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
- MS patients having abnormal kidney function (creatinine clearance <59)
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 |
|---|---|---|
| MRIAll subjects will undergo a MRI. | Other | Copaxone MRI, Healthy Controls MRI |
Primary outcome
To explore whether treatment with GA may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls.
Time frame: 24 months
MRI collected from RRMS patients who have taken Copaxone for 24 months
1 secondary outcome
To investigate whether treatment with GA may decrease accumulation of iron in lesions, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months.
Time frame: 24 months
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 25 Mar 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 11 inclusion and 5 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 25 Mar 2013. 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?
To explore whether treatment with GA may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2013.