Multiple SclerosisNCT02308670
Evaluate the Effect of Switching From Daily Injections of 20mg Glatiramer Acetate (GA) to 40mg GA Three Times a Week in Subjects With Relapsing-remitting Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University at Buffalo at 1 site in United States.
Trial summary
The primary aim of this study is to observe any changes in MRI in MS patients who have switched from 20mg injections/day to 3 40mg injections/week of glatiramer acetate. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Oct 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: One hundred fifty (150) consecutive RRMS patients who are on treatment with GA 20mg/daily for at least 12 months and who switched to GA 40mg x 3/weekly, because of convenience of application, will be recruited in the study.
Who may be able to join
- MS patients diagnosed with MS according to the McDonald criteria
- MS patients having a relapsing disease course
- Being on GA monotherapy (20mg/daily sc) for at least 12 months prior to the standard of care MRI at the time of switch to GA 40mg x 3/weekly
- Having standard of care 3T MRI scan while on GA 20mg/daily treatment for at least 12-18 months prior to the start day of the of the GA 40mg x 3/weekly and at the time of switch to GA 40mg x 3/weekly Age over 18
- Pass MRI health screening (in case of EGFR <59, the contrast will not be applied)
- None of the exclusion criteria
Who cannot join
- Patients who had a relapse within 30 days prior to MRI scan date
- Patients who received steroid treatment within 30 days prior to the MRI 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 12 months prior to start of GA 40mg 3/weekly (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
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: An Open-label, Prospective, Observational, Single-blinded, Longitudinal, Cross-over Study to Evaluate the Effect of Switching From Daily Injections of 20mg Glatiramer Acetate (GA) to 40mg GA Three Times a Week on Thalamic Pathology in Subjects With Relapsing-remitting Multiple Sclerosis
The primary aim of this study is to observe any changes in MRI in MS patients who have switched from 20mg injections/day to 3 40mg injections/week of glatiramer acetate.
Read the detailed description
The primary aim of this study is to observe the effect of switching from daily injections of 20mg glatiramer acetate (GA) (20mg/daily) to GA 40mg three times a week (40mg x 3/weekly) on thalamus pathology, as measured by changes in diffusion-tensor imaging (DTI) in patients with relapsing-remitting multiple sclerosis (RRMS). We hypothesize that GA 40mg x 3/weekly will exert similar, if not better effect on prevention of thalamic pathology, as compared to GA 20mg/daily. The secondary objective of this study is to investigate the effect of switching from GA 20mg/daily to GA 40mg x 3/weekly on evolution of microstructural changes in normal appearing white matter (NAWM) and normal appearing gray matter (NAGM), as measured by DTI.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RRMS changing from 20mg to 40mg GA | Relapsing-remitting Multiple Sclerosis patients who are switching from 20mg of glatiramer acetate (GA) to 40mg. The investigator is not influencing this clinical decision, just measuring its impact using MRI metrics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute and percent change in thalamus pathology as measured by axial and radial diffusivity using diffusion tensor imaging tract-based spatial statistics
The primary endpoint is to explore the effect of GA 40mg x 3/weekly on thalamus pathology, as measured by changes in RD and AD on DTI TBSS in patients with RRMS, as compared to GA 20mg/daily.
Measured: 1 year after enrollment
Secondary outcomes (1)
Absolute and percent changes in normal-appearing white and grey matter as measured by fractional anisotropy and mean diffusivity using diffusion tensor imaging tract-based spatial statistics.
The secondary endpoint is to investigate the effect of GA 40mg x 3/weekly on evolution of microstructural changes in NAWM and NAGM, as measured by FA and MD on DTI global and the TBSS (only NAWM) approaches, as compared to GA 20mg/daily.
Measured: 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2016
- Study completionOct 2016
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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Principal investigator, Robert Zivadinov, MD, PhD, University at Buffalo
- Investigators
- Robert Zivadinov, MD, PhD, Principal investigator, SUNY University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308670
- Sponsor's protocol ID
- GA20-40
- Status last verified
- Oct 2016
- First submitted
- 23 Jul 2014
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zivadinov R, Bergsland N, Hagemeier J, Tavazzi E, Ramasamy DP, Durfee J, Cherneva M, Carl E, Carl J, Kolb C, Hojnacki D, Weinstock-Guttman B. Effect of switching from glatiramer acetate 20 mg/daily to glatiramer acetate 40 mg three times a week on gray and white matter pathology in subjects with relapsing multiple sclerosis: A longitudinal DTI study. J Neurol Sci. 2018 Apr 15;387:152-156. doi: 10.1016/j.jns.2018.02.023. Epub 2018 Feb 10.
PubMed 29571854
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Prospective, Observational, Single-blinded, Longitudinal, Cross-over Study to Evaluate the Effect of Switching From Daily Injections of 20mg Glatiramer Acetate (GA) to 40mg GA Three Times a Week on Thalamic Pathology in Subjects With Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02308670
- Acronym / sponsor ID
- GA20-40
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- Jul 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 4 Dec 2014 (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 primary aim of this study is to observe any changes in MRI in MS patients who have switched from 20mg injections/day to 3 40mg injections/week of glatiramer acetate.
Detailed description
The primary aim of this study is to observe the effect of switching from daily injections of 20mg glatiramer acetate (GA) (20mg/daily) to GA 40mg three times a week (40mg x 3/weekly) on thalamus pathology, as measured by changes in diffusion-tensor imaging (DTI) in patients with relapsing-remitting multiple sclerosis (RRMS). We hypothesize that GA 40mg x 3/weekly will exert similar, if not better effect on prevention of thalamic pathology, as compared to GA 20mg/daily. The secondary objective of this study is to investigate the effect of switching from GA 20mg/daily to GA 40mg x 3/weekly on evolution of microstructural changes in normal appearing white matter (NAWM) and normal appearing gray matter (NAGM), as measured by DTI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RRMS changing from 20mg to 40mg GA | – | –Relapsing-remitting Multiple Sclerosis patients who are switching from 20mg of glatiramer acetate (GA) to 40mg. The investigator is not influencing this clinical decision, just measuring its impact using MRI metrics. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred fifty (150) consecutive RRMS patients who are on treatment with GA 20mg/daily for at least 12 months and who switched to GA 40mg x 3/weekly, because of convenience of application, will be recruited in the study.
Key inclusion criteria (6 listed)
- MS patients diagnosed with MS according to the McDonald criteria
- MS patients having a relapsing disease course
- Being on GA monotherapy (20mg/daily sc) for at least 12 months prior to the standard of care MRI at the time of switch to GA 40mg x 3/weekly
- Having standard of care 3T MRI scan while on GA 20mg/daily treatment for at least 12-18 months prior to the start day of the of the GA 40mg x 3/weekly and at the time of switch to GA 40mg x 3/weekly Age over 18
- Pass MRI health screening (in case of EGFR <59, the contrast will not be applied)
Key exclusion criteria (4 listed)
- Patients who had a relapse within 30 days prior to MRI scan date
- Patients who received steroid treatment within 30 days prior to the MRI 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 12 months prior to start of GA 40mg 3/weekly (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
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
Absolute and percent change in thalamus pathology as measured by axial and radial diffusivity using diffusion tensor imaging tract-based spatial statistics
Time frame: 1 year after enrollment
The primary endpoint is to explore the effect of GA 40mg x 3/weekly on thalamus pathology, as measured by changes in RD and AD on DTI TBSS in patients with RRMS, as compared to GA 20mg/daily.
1 secondary outcome
Absolute and percent changes in normal-appearing white and grey matter as measured by fractional anisotropy and mean diffusivity using diffusion tensor imaging tract-based spatial statistics.
Time frame: 1 year after enrollment
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 Oct 2016.
- Derived from this study: PubMed 29571854Zivadinov R, Bergsland N, Hagemeier J, Tavazzi E, Ramasamy DP, Durfee J, Cherneva M, Carl E, Carl J, Kolb C, Hojnacki D, Weinstock-Guttman B. Effect of switching from glatiramer acetate 20 mg/daily to glatiramer acetate 40 mg three times a week on gray and white matter pathology in subjects with relapsing multiple sclerosis: A longitudinal DTI study. J Neurol Sci. 2018 Apr 15;387:152-156. doi: 10.1016/j.jns.2018.02.023. Epub 2018 Feb 10.
- Individual participant dataSharing planned: No
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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 principal investigator
SUNY University at Buffalo
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 6 inclusion and 4 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 Oct 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?
Absolute and percent change in thalamus pathology as measured by axial and radial diffusivity using diffusion tensor imaging tract-based spatial statistics (time frame: 1 year after enrollment). 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 NCT02308670, 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 25 Oct 2016.