Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Ac
Comparison of Standard 1.5 Versus 3T Optimized Protocols in Patients Treated With Glatiramer Acetate. A Conventional and Non-conventional MRI Study
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Glatiramer acetate
Unknown
Results by group
A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol.
Change from baseline at 180 days and change from baseline at 360 days
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Patients Diagnosed With Multiple Sclerosis Who Have the Presen | -3.7 GAD lesions (number of) | 5.8 (Standard Deviation) | 16 |
| Patients Diagnosed With Multiple Sclerosis Who Have the Presen | -3.6 GAD lesions (number of) | 4.2 (Standard Deviation) | 16 |
Patients Diagnosed With Multiple Sclerosis Who Have the Presen
Patients Diagnosed With Multiple Sclerosis Who Have the Presen
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| RRMS Patients With >=1 GdE Lesion or Acute Relapse | 12 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol.
Change from baseline at 180 days and change from baseline at 360 days
MRI lesions
Who could take part
Relapsing MS · 18 to 65
Show the full criteria
Inclusion criteria
* Patients diagnosed with clinically definite MS according to the McDonald criteria * Have a Gd enhancing lesion using 1.5T standard protocol and/or an acute relapse * Age 18-65 * Have a relapsing-remitting (RR) disease course or clinically isolated syndrome (CIS) with high risk of conversion to clinically definite (CD) MS (presence of >9 T2 lesions in addition to 1 Gd lesion) * Have EDSS scores less than or equal to 5.5 * Have disease duration of 3 months to 30 years * None of the exclusion criteria
Exclusion criteria
* Previous immunomodulatory or immunosuppressant treatment during the 30 days prior to day 0 of the study with the following agents (e.g., IFN-β, GA, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study will: * Explore whether GA decreases inflammation more on the 3T optimized protocol when compared to the 1.5T standard protocol. * Compare whether the decrease in the cumulative number of Gd-enhancing lesions significantly differs between pre-treatment (day 0) and post-treatment (12 months) using 1.5T standard and 3T optimized protocols. * Investigate the correlation between MTR and the cumulative number and volume of Gd enhancing lesions on 1.5T standard and 3T optimized protocols in patients treated with GA. This study suggests that GA may favorably affect early events in lesion formation, in addition to exerting more transient beneficial effects on established areas of inflammation and demyelination, and that this effect may be observed only with the 3T optimized protocol.
Papers
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History
Started
Sept 2007
Main results due
Jul 2010
Finished
Apr 2011
Results posted
Dec 2014