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Gadolinium-enhancing or active T2 magnetic resonance imaging lesions in multiple sclerosis clinical trials?
Multiple Sclerosis, 07/06/09
Bonzano L et al. – Defining either active T2 or gadolinium (Gd)-enhancing lesions as a magnetic resonance imaging (MRI) endpoint is not key to monitoring MRI activity in multiple sclerosis (MS) clinical trials. The choice of the best MRI endpoint should be based on other considerations (sensitivity, reproducibility, time for assessment, safety, pt comfort). Further monitoring active T2 lesions could allow less expensive trials, without requiring injection of Gd-based contrast agents.
Methods- Study of the relationship between treatment effects estimated on T2-weighted or Gd-enhanced T1-weighted MRI
- Data extraction from published randomized clinical trials in relapsing-remitting MS with frequent MRI, reporting both active T2 and Gd-enhancing lesions
- Regression analysis between treatment effects estimated on 2 different MRI endpoints
- Strong association between the treatment effect on Gd-enhancing lesions and on active T2 lesions
- Treatment effect estimates almost the same
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