Table 2 Secondary objectives of the MESEMS project
Aim | Measures |
|---|---|
To compare the number of active MRI lesions in the placebo vs active treatment periods in both groups | Number of GEL counted over weeks 28, 36, and 48 (cross-over re-treatment) compared with the number of GEL counted over 4, 12, and 24 weeks (placebo vs active treatment periods) within each group |
To evaluate efficacy of MSC in reducing combined MRI activity and volume of black holes (BH) in both treatment groups at 24 weeks | Combined unique MRI activity (number of new or enlarging T2w, or enhancing or re-enhancing lesions) and volume of GEL over 4, 12, and 24 weeks compared between treatment groups. Volume of BH over 24 weeks compared between treatment groups |
To compare combined MRI activity and volume of BH in the placebo vs active treatment periods in both groups | Combined unique MRI activity and volume of GEL over weeks 28, 36, and 48 (cross-over re-treatment) compared with the same outcomes over 4, 12, and 24 weeks (placebo vs active treatment periods) within each group. Volume of BH over week 48 (cross-over re-treatment) compared with the same outcome over week 24 week (placebo vs active treatment periods) within each group |
To evaluate efficacy of MSC in reducing the volume of T2 lesions in both treatment groups at 24 weeks | Volume of T2w lesions over 24 weeks compared between treatment groups |
To compare the volume of T2 lesions in the placebo vs active treatment periods in both groups | Volume of T2w lesions over week 48 (cross-over re-treatment) compared with the same outcome over week 24 week (placebo vs active treatment periods) within each group |
To evaluate efficacy of MSC in reducing relapses at 24 weeks and to compare the number of relapses in the placebo vs active treatment periods in both groups | Number of relapses in MSC treatment group vs placebo group in the first 24 weeks and after cross-over re-treatment in the two groups (see below for definition of relapse) |
To evaluate efficacy of MSC in reducing the time to sustained progression of disability and increasing the number of progression-free patients at 24 weeks and to compare the time to sustained progression of disability and the proportion of progression-free patients in the placebo vs active treatment periods in both groups* | Time to sustained progression of disability and proportion of progression-free patients compared between treatment groups during the first 24 weeks and after cross-over re-treatment in the two groups |
To evaluate efficacy of MSC in increasing the number of progression-free patients at 24 weeks and to compare the proportion of disease-free patients in the placebo vs active treatment periods in both groups§ | Proportion of disease-free patients compared between treatment groups during the first 24 weeks and after cross-over re-treatment in the two groups |
To evaluate the efficacy of MSC treatment in clinical scores such a Multiple Sclerosis Functional Composite (MSFC) score and Symbol Digit Modalities Test (SDMT) score | Changes in MSFC and SDMT scores in the MSC treated group vs placebo group during the first 24 weeks and after cross-over re-treatment in the two groups |