Relapsing Remitting Multiple Sclerosis (RRMS)
Conditions
Keywords
TYSABRI naive, Relapsing-remitting multiple sclerosis (RRMS)
Brief summary
The primary objective of the study is to evaluate the evolution of walking capacity as measured by the timed 100-meter walk test (T100T), timed 25-foot walk test (T25FW), maximum walking distance (MWD), and Expanded Disability Status Scale (EDSS) during the first year of therapy with natalizumab. The secondary objectives of this study are as follows: * To evaluate the correlation between the MWD and EDSS and both walking tests, the T100T and the T25FW at Baseline, at Week 24 and at Week 48 of therapy. * To determine how well each of the walking tests, T100T or T25FW, predicts walking limitations in all participants and in the subgroups of participants stratified by baseline EDSS.
Interventions
Sponsors
Elan Pharmaceuticals
Biogen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Must give written informed consent and provide all authorizations required by local law (for example, Protected Health Information \[PHI\]) * Men or women between 18 and 60 years of age, inclusive * Must have Expanded Disability Status Scale (EDSS) less than or equal to 5.5 at baseline * Must be able to walk at least 100 m without assistive devices * Must be natalizumab-naïve * Must have a documented diagnosis of a relapsing remitting form of multiple sclerosis (MS0 as defined by the revised McDonald Committee criteria (Polman et al., 2005) * Must have had a recent (within 3 months from baseline) magnetic resonance imaging (MRI) * Must have had at least 1 relapse in the previous year and must satisfy the locally approved therapeutic indications for Tysabri. If Tysabri is not yet approved in a specific country, patients must fulfill the following criteria: * Patients with high disease activity despite treatment with a beta-interferon defined as patients who have failed to respond to a full and adequate course of a beta-interferon * Patients must have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2 hyperintense lesions in cranial MRI or at least 1 gadolinium (Gd)-enhancing lesion * Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined as patients who have had 2 or more disabling relapses in one year and 1 or more Gd-enhancing lesions on brain MRI or significant increase in T2 lesions as compared to a previous MRI * Must be stable in disability for at least 30 days prior to enrollment to the study * Must be stable in symptomatic management of the disease, specifically spasticity, depression and fatigue for at least 30 days prior to enrollment to the study * Must be considered by the Investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy (PML) based on medical history, physical examination, or laboratory testing * Must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including interferon \[IFN\] and glatiramer acetate \[GA\]) while being treated with natalizumab during the study. Key
Exclusion criteria
Unless otherwise specified, candidates will be excluded from study entry if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Timed 25-foot Walk Test (T25FW) | Baseline, Week 24, Week 48 | In the T25FW, the participant is instructed to walk as fast as possible for a distance of 25 feet. |
| Change From Baseline in Maximum Walking Distance (MWD) | Baseline, Week 24, Week 48 | — |
| Change From Baseline in the Timed 100-meter Walk Test (T100T) | Baseline, Week 24, Week 48 | In the T100T, the participant is instructed to walk as fast as possible for a distance of 100 meters. |
| Change From Baseline in Expanded Disability Status Scale (EDSS) | Baseline, Week 24, Week 48 | EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between the EDSS and T25FW (Pearson Correlation Coefficient) | Baseline, Week 24, Week 48 | Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. |
| Correlation Between the EDSS and T25FW (Spearman Correlation Coefficient) | Baseline, Week 24, Week 48 | Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. |
| Correlation Between the EDSS and MWD (Pearson Correlation Coefficient) | Baseline, Week 24, Week 48 | Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. |
| Correlation Between the EDSS and T100T (Spearman Correlation Coefficient) | Baseline, Week 24, Week 48 | Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. |
| Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | Baseline, Week 24, Week 48 | To determine how well each of the walking tests, T100T or T25FW, predicts walking limitations, participants were stratified by baseline EDSS scores, and walking tests at Weeks 24 and 48 were analyzed. A 15% or 20% improvement indicates that, when compared with baseline walking speed (meters per second), there is at least 15% or 20% improvement at the corresponding timepoint, e.g. (speed at Week 24 - speed at baseline)/speed at baseline\*100% ≥ 15% or 20%. Confirmed (conf) improvement at Week 48 indicates that the participant has at least 15% (or 20%) improvement in walking speed at both Week 24 and Week 48. |
| Correlation Between the EDSS and T100T (Pearson Correlation Coefficient) | Baseline, Week 24, Week 48 | Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. |
| Correlation Between the EDSS and MWD (Spearman Correlation Coefficient) | Baseline, Week 24, Week 48 | Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. |
| Correlation Between the T100T and T25FW (Pearson Correlation Coefficient) | Baseline, Week 24, Week 48 | Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. |
| Correlation Between the T100T and T25FW (Spearman Correlation Coefficient) | Baseline, Week 24, Week 48 | Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. |
Countries
Belgium, Mexico, Poland, Romania, Saudi Arabia, Ukraine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Natalizumab natalizumab 300 mg IV every 4 weeks for 48 weeks | 215 |
| Total | 215 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Death | 1 |
| Overall Study | Enrolled But Not Treated | 6 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Voluntary Discontinuation | 4 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Natalizumab |
|---|---|
| Age, Continuous | 35.1 years STANDARD_DEVIATION 9.56 |
| Sex: Female, Male Female | 137 Participants |
| Sex: Female, Male Male | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 28 / 218 |
| serious Total, serious adverse events | 7 / 218 |
Outcome results
Primary
Change From Baseline in Expanded Disability Status Scale (EDSS)
EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.
Time frame: Baseline, Week 24, Week 48
Population: Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Natalizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) | Baseline; n=215 | 4.0 units on a scale |
| Natalizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) | Change from Baseline at Week 24; n=207 | 0.0 units on a scale |
| Natalizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) | Change from Baseline at Week 48; n=199 | 0.0 units on a scale |
Comparison: Baseline, Week 24p-value: <0.0001Wilcoxon signed rank test
Comparison: Baseline, Week 48p-value: <0.0001Wilcoxon signed rank test
Primary
Change From Baseline in Maximum Walking Distance (MWD)
Time frame: Baseline, Week 24, Week 48
Population: Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=those participants with observed data at given time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Natalizumab | Change From Baseline in Maximum Walking Distance (MWD) | Baseline; n=143 | 350.0 meters |
| Natalizumab | Change From Baseline in Maximum Walking Distance (MWD) | Change from Baseline at Week 24; n=136 | 0.0 meters |
| Natalizumab | Change From Baseline in Maximum Walking Distance (MWD) | Change from Baseline at Week 48; n=129 | 0.0 meters |
Comparison: Baseline, Week 24p-value: <0.0001Wilcoxon signed rank test
Comparison: Baseline, Week 48p-value: 0.0157Wilcoxon signed rank test
Primary
Change From Baseline in the Timed 100-meter Walk Test (T100T)
In the T100T, the participant is instructed to walk as fast as possible for a distance of 100 meters.
Time frame: Baseline, Week 24, Week 48
Population: Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Natalizumab | Change From Baseline in the Timed 100-meter Walk Test (T100T) | Baseline; n=215 | 86.0 seconds |
| Natalizumab | Change From Baseline in the Timed 100-meter Walk Test (T100T) | Change from Baseline at Week 24; n=207 | -1.2 seconds |
| Natalizumab | Change From Baseline in the Timed 100-meter Walk Test (T100T) | Change from Baseline at Week 48; n=199 | -1.6 seconds |
Comparison: Baseline, Week 24p-value: 0.0003Wilcoxon signed rank test
Comparison: Baseline, Week 48p-value: 0.0002Wilcoxon signed rank test
Primary
Change From Baseline in the Timed 25-foot Walk Test (T25FW)
In the T25FW, the participant is instructed to walk as fast as possible for a distance of 25 feet.
Time frame: Baseline, Week 24, Week 48
Population: Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Natalizumab | Change From Baseline in the Timed 25-foot Walk Test (T25FW) | Baseline; n=215 | 6.6 seconds |
| Natalizumab | Change From Baseline in the Timed 25-foot Walk Test (T25FW) | Change from Baseline at Week 24; n=207 | -0.1 seconds |
| Natalizumab | Change From Baseline in the Timed 25-foot Walk Test (T25FW) | Change from Baseline at Week 48; n=199 | -0.1 seconds |
Comparison: Baseline, Week 24p-value: 0.0148Wilcoxon signed rank test
Comparison: Baseline, Week 48p-value: 0.0119Wilcoxon signed rank test
Secondary
Correlation Between the EDSS and MWD (Pearson Correlation Coefficient)
Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation.
Time frame: Baseline, Week 24, Week 48
Population: Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Natalizumab | Correlation Between the EDSS and MWD (Pearson Correlation Coefficient) | Baseline; n=143 | -0.7245 Correlation coefficient |
| Natalizumab | Correlation Between the EDSS and MWD (Pearson Correlation Coefficient) | Change from Baseline at Week 24; n=131 | -0.6937 Correlation coefficient |
| Natalizumab | Correlation Between the EDSS and MWD (Pearson Correlation Coefficient) | Change from Baseline at week 48; n=124 | -0.4188 Correlation coefficient |
Comparison: Baselinep-value: <0.0001Pearson Correlation
Comparison: Change from Baseline at Week 24p-value: <0.0001Pearson Correlation
Comparison: Change from Baseline at Week 48p-value: <0.0001Pearson Correlation
Secondary
Correlation Between the EDSS and MWD (Spearman Correlation Coefficient)
Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation.
Time frame: Baseline, Week 24, Week 48
Population: Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Natalizumab | Correlation Between the EDSS and MWD (Spearman Correlation Coefficient) | Baseline; n=143 | -0.9197 Correlation coefficient |
| Natalizumab | Correlation Between the EDSS and MWD (Spearman Correlation Coefficient) | Change from Baseline at Week 24; n=131 | -0.6797 Correlation coefficient |
| Natalizumab | Correlation Between the EDSS and MWD (Spearman Correlation Coefficient) | Change from Baseline at week 48; n=124 | -0.5861 Correlation coefficient |
Comparison: Baselinep-value: <0.0001Spearman correlation
Comparison: Change from Baseline at Week 24p-value: <0.0001Spearman correlation
Comparison: Change from Baseline at Week 48p-value: <0.0001Spearman correlation
Secondary
Correlation Between the EDSS and T100T (Pearson Correlation Coefficient)
Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation.
Time frame: Baseline, Week 24, Week 48
Population: Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Natalizumab | Correlation Between the EDSS and T100T (Pearson Correlation Coefficient) | Baseline; n=215 | 0.5356 Correlation coefficient |
| Natalizumab | Correlation Between the EDSS and T100T (Pearson Correlation Coefficient) | Change from Baseline at Week 24; n=207 | 0.2176 Correlation coefficient |
| Natalizumab | Correlation Between the EDSS and T100T (Pearson Correlation Coefficient) | Change from Baseline at Week 48; n=199 | 0.1218 Correlation coefficient |
Comparison: Baselinep-value: <0.0001Pearson Correlation
Comparison: Change from Baseline at Week 24p-value: 0.0016Pearson Correlation
Comparison: Change from Baseline at Week 48p-value: 0.0866Pearson Correlation
Secondary
Correlation Between the EDSS and T100T (Spearman Correlation Coefficient)
Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation.
Time frame: Baseline, Week 24, Week 48
Population: Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Natalizumab | Correlation Between the EDSS and T100T (Spearman Correlation Coefficient) | Baseline; n=215 | 0.7269 Correlation coefficient |
| Natalizumab | Correlation Between the EDSS and T100T (Spearman Correlation Coefficient) | Change from Baseline at Week 24; n=207 | 0.3778 Correlation coefficient |
| Natalizumab | Correlation Between the EDSS and T100T (Spearman Correlation Coefficient) | Change from Baseline at Week 48; n=199 | 0.2898 Correlation coefficient |
Comparison: Baselinep-value: <0.0001Spearman correlation
Comparison: Change from Baseline at Week 24p-value: <0.0001Spearman correlation
Comparison: Change from Baseline at Week 48p-value: <0.0001Spearman correlation
Secondary
Correlation Between the EDSS and T25FW (Pearson Correlation Coefficient)
Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation.
Time frame: Baseline, Week 24, Week 48
Population: Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Natalizumab | Correlation Between the EDSS and T25FW (Pearson Correlation Coefficient) | Baseline; n=215 | 0.5134 Correlation coefficient |
| Natalizumab | Correlation Between the EDSS and T25FW (Pearson Correlation Coefficient) | Change from Baseline at Week 24; n=207 | 0.1945 Correlation coefficient |
| Natalizumab | Correlation Between the EDSS and T25FW (Pearson Correlation Coefficient) | Change from Baseline at Week 48; n=199 | 0.1237 Correlation coefficient |
Comparison: Baselinep-value: <0.0001Pearson Correlation
Comparison: Change from Baseline at Week 24p-value: <0.0001Pearson Correlation
Comparison: Change from Baseline at Week 48p-value: <0.0001Pearson Correlation
Secondary
Correlation Between the EDSS and T25FW (Spearman Correlation Coefficient)
Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation.
Time frame: Baseline, Week 24, Week 48
Population: Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Natalizumab | Correlation Between the EDSS and T25FW (Spearman Correlation Coefficient) | Baseline; n=215 | 0.7574 Correlation coefficient |
| Natalizumab | Correlation Between the EDSS and T25FW (Spearman Correlation Coefficient) | Change from Baseline at Week 24; n=207 | 0.2623 Correlation coefficient |
| Natalizumab | Correlation Between the EDSS and T25FW (Spearman Correlation Coefficient) | Change from Baseline at Week 48; n=199 | 0.2661 Correlation coefficient |
Comparison: Baselinep-value: <0.0001Spearman correlation
Comparison: Change from Baseline at Week 24p-value: <0.0001Spearman correlation
Comparison: Change from Baseline at Week 48p-value: <0.0001Spearman correlation
Secondary
Correlation Between the T100T and T25FW (Pearson Correlation Coefficient)
Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation.
Time frame: Baseline, Week 24, Week 48
Population: Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Natalizumab | Correlation Between the T100T and T25FW (Pearson Correlation Coefficient) | Baseline; n=215 | 0.9235 Correlation coefficient |
| Natalizumab | Correlation Between the T100T and T25FW (Pearson Correlation Coefficient) | Change from Baseline at Week 24; n=207 | 0.4752 Correlation coefficient |
| Natalizumab | Correlation Between the T100T and T25FW (Pearson Correlation Coefficient) | Change from Baseline at week 48; n=199 | 0.4827 Correlation coefficient |
Comparison: Baselinep-value: <0.0001Pearson Correlation
Comparison: Change from Baseline at Week 24p-value: <0.0001Pearson Correlation
Comparison: Change from Baseline at Week 48p-value: <0.0001Pearson Correlation
Secondary
Correlation Between the T100T and T25FW (Spearman Correlation Coefficient)
Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation.
Time frame: Baseline, Week 24, Week 48
Population: Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Natalizumab | Correlation Between the T100T and T25FW (Spearman Correlation Coefficient) | Baseline; n=215 | 0.8737 Correlation coefficient |
| Natalizumab | Correlation Between the T100T and T25FW (Spearman Correlation Coefficient) | Change from Baseline at Week 24; n=207 | 0.5558 Correlation coefficient |
| Natalizumab | Correlation Between the T100T and T25FW (Spearman Correlation Coefficient) | Change from Baseline at Week 48; n=199 | 0.4777 Correlation coefficient |
Comparison: Baselinep-value: <0.0001Spearman correlation
Comparison: Change from Baseline at Week 24p-value: <0.0001Spearman correlation
Comparison: Change from Baseline at Week 48p-value: <0.0001Spearman correlation
Secondary
Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48
To determine how well each of the walking tests, T100T or T25FW, predicts walking limitations, participants were stratified by baseline EDSS scores, and walking tests at Weeks 24 and 48 were analyzed. A 15% or 20% improvement indicates that, when compared with baseline walking speed (meters per second), there is at least 15% or 20% improvement at the corresponding timepoint, e.g. (speed at Week 24 - speed at baseline)/speed at baseline\*100% ≥ 15% or 20%. Confirmed (conf) improvement at Week 48 indicates that the participant has at least 15% (or 20%) improvement in walking speed at both Week 24 and Week 48.
Time frame: Baseline, Week 24, Week 48
Population: Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n= number of participants with evaluable data at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Natalizumab | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 15% Improved at Week 24; n=53,74,80 | 6 participants |
| Natalizumab | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 15% Improved at Week 48; n=52,74,73 | 8 participants |
| Natalizumab | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 15% Improved at Week 48 conf; n=52,74,72 | 3 participants |
| Natalizumab | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 20% Improved at Week 24; n=52,74,80 | 5 participants |
| Natalizumab | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 20% Improved at Week 48; n=52,74,73 | 6 participants |
| Natalizumab | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 20% Improved at Week 48 conf; n=52,74,72 | 2 participants |
| Natalizumab | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 15% Improved at Week 24; n=53,74,80 | 11 participants |
| Natalizumab | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 15% Improved at Week 48; n=52,74,73 | 11 participants |
| Natalizumab | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 15% Improved at Week 48 conf; n=52,74,72 | 7 participants |
| Natalizumab | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 20% Improved at Week 24; n=53,74,80 | 10 participants |
| Natalizumab | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 20% Improved at Week 48; n=52,74,73 | 9 participants |
| Natalizumab | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 20% Improved at Week 48 conf; n=52,74,72 | 6 participants |
| Natalizumab: Baseline EDSS 3.0 to 4.0 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 20% Improved at Week 48 conf; n=52,74,72 | 9 participants |
| Natalizumab: Baseline EDSS 3.0 to 4.0 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 15% Improved at Week 24; n=53,74,80 | 11 participants |
| Natalizumab: Baseline EDSS 3.0 to 4.0 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 15% Improved at Week 24; n=53,74,80 | 13 participants |
| Natalizumab: Baseline EDSS 3.0 to 4.0 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 15% Improved at Week 48 conf; n=52,74,72 | 12 participants |
| Natalizumab: Baseline EDSS 3.0 to 4.0 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 15% Improved at Week 48; n=52,74,73 | 12 participants |
| Natalizumab: Baseline EDSS 3.0 to 4.0 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 20% Improved at Week 48 conf; n=52,74,72 | 4 participants |
| Natalizumab: Baseline EDSS 3.0 to 4.0 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 20% Improved at Week 48; n=52,74,73 | 17 participants |
| Natalizumab: Baseline EDSS 3.0 to 4.0 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 15% Improved at Week 48 conf; n=52,74,72 | 6 participants |
| Natalizumab: Baseline EDSS 3.0 to 4.0 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 15% Improved at Week 48; n=52,74,73 | 20 participants |
| Natalizumab: Baseline EDSS 3.0 to 4.0 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 20% Improved at Week 48; n=52,74,73 | 8 participants |
| Natalizumab: Baseline EDSS 3.0 to 4.0 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 20% Improved at Week 24; n=52,74,80 | 8 participants |
| Natalizumab: Baseline EDSS 3.0 to 4.0 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 20% Improved at Week 24; n=53,74,80 | 10 participants |
| Natalizumab: Baseline EDSS >= 4.5 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 20% Improved at Week 24; n=52,74,80 | 14 participants |
| Natalizumab: Baseline EDSS >= 4.5 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 20% Improved at Week 48; n=52,74,73 | 12 participants |
| Natalizumab: Baseline EDSS >= 4.5 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 20% Improved at Week 24; n=53,74,80 | 18 participants |
| Natalizumab: Baseline EDSS >= 4.5 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 20% Improved at Week 48 conf; n=52,74,72 | 7 participants |
| Natalizumab: Baseline EDSS >= 4.5 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 15% Improved at Week 24; n=53,74,80 | 24 participants |
| Natalizumab: Baseline EDSS >= 4.5 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 15% Improved at Week 48; n=52,74,73 | 24 participants |
| Natalizumab: Baseline EDSS >= 4.5 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 20% Improved at Week 48; n=52,74,73 | 23 participants |
| Natalizumab: Baseline EDSS >= 4.5 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 15% Improved at Week 24; n=53,74,80 | 19 participants |
| Natalizumab: Baseline EDSS >= 4.5 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 15% Improved at Week 48; n=52,74,73 | 15 participants |
| Natalizumab: Baseline EDSS >= 4.5 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 15% Improved at Week 48 conf; n=52,74,72 | 21 participants |
| Natalizumab: Baseline EDSS >= 4.5 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T25FW: 15% Improved at Week 48 conf; n=52,74,72 | 10 participants |
| Natalizumab: Baseline EDSS >= 4.5 | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | T100T: 20% Improved at Week 48 conf; n=52,74,72 | 16 participants |