A Canadian Study Assessing the Utility of the Treatment Optimization Recommendations in Multiple Sclerosis (CanTOR)
The Canadian Multiple Sclerosis Working Group (CMSWG) has developed practical recommendations on how neurologists can assess the status of subjects on disease modifying drugs (DMDs) and decide when it may be necessary to modify treatment in order to optimize outcomes. These recommendations are based on relapses, disease progression as measured by the Expanded Disability Status Scale (EDSS) or EDSS progression, and magnetic resonance imaging (MRI) outcomes. The CMSWG agreed to compare post-treatment relapse rates and severity to baseline rates and severity in each individual subject. The recommended minimum baseline reference time frame needed to assess relapse rate was 2 years prior to treatment initiation. The objective and prospective relapse data should be ideally collected during this reference period. The CMSWG recommended that the following should be taken into consideration when assessing relapse severity: the effect of the relapse on activities of daily living (ADL), the type and number of systems involved (i.e., relapses that are polysymptomatic or that affect the cerebellar/motor systems tend to be more severe), and whether or not a course of corticosteroids was required. The CMSWG also recommended that, prior to considering treatment modification on the basis of progression in disability, progression should be confirmed at 6 months.
The CMSWG's Treatment Optimization Recommendations (TORs) have been retrospectively applied to the 4 year data set from the PRISMS study. Applying the model to subjects after their first year on therapy allowed for accurate prediction of continued disease activity in the form of relapses in the majority of subjects who actually experienced ongoing attacks. The model was less effective in predicting disability progression, but this may well have been due to the low numbers of subjects on treatment progressing over the study period. This observational study used the TOR model to identify subjects as either candidates for therapy optimization or as candidates to maintain current therapy. All subjects were then followed prospectively until re- assessment will be done with this model.
Multiple Sclerosis, Relapsing-Remitting
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Canadian Assessment of the Utility of the Treatment Optimization Recommendations in Multiple Sclerosis|
- Assessment of history or current status of Expanded Disability Status Score (EDSS) [ Time Frame: Baseline to 12 month TOR assessment ] [ Designated as safety issue: No ]
- Assessment of history or current relapse status [ Time Frame: Baseline to 12 month TOR assessment ] [ Designated as safety issue: No ]
- Assessment of history or current magnetic resonance imaging (MRI) status [ Time Frame: Baseline to 12 month TOR assessment ] [ Designated as safety issue: No ]
- Assessment of history or current cognitive status [ Time Frame: Baseline to 12 month TOR assessment ] [ Designated as safety issue: No ]
- Assessment of history or current status of neutralizing antibodies (NAb) [ Time Frame: Baseline to 12 month TOR assessment ] [ Designated as safety issue: No ]
- Treatment Optimization Recommendation Questionnaire [ Time Frame: At the end of the 12 months observational period. ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|