Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis,, demyelinating autoimmune diseases,, interleukin-17,, monoclonal human antibody
Brief summary
The study will assess the long-term safety and tolerability of AIN457 in patients with relapsing-remitting multiple sclerosis (RRMS). In addition the long-term pattern of maintenance of efficacy and health related quality of life will be explored.
Interventions
DRUGAIN457
(10mg/kg i.v.).
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1\. Was exposed to AIN457 or placebo in study CAIN457B2201 and completed the CAIN457B2201 study, up to at and including Visit 10 (week 24).
Exclusion criteria
1. Have been treated with: * immunosuppressive medications such as azathioprine or methotrexate within 1 month prior to enrollment, if lymphocyte count normal. * immunoglobulins and/or monoclonal antibodies (with the exception of AIN457) within 2 month prior to enrollment, or if the immunosuppressive effects are likely to persist at enrollment (such as presence of B cell depletion after rituximab treatment). 2. Have received total lymphoid irradiation, bone marrow transplantation, alemtuzumab, cladribine, cyclophosphamide, mitoxantrone or other immunosuppressive treatments with long-lasting (over 6 months) or permanent effects. 3. Have received any live or live attenuated vaccines (including live vaccines for varicella-zoster virus or measles) within 2 months prior to enrollment. 4. A diagnosis of chronic disease of the immune system other than MS, or of an immunodeficiency syndrome. 5. Current severe depression. 6. Pregnant or nursing (lactating) women. 7. Malignancy diagnosed since enrollment in the core study (except for successfully-treated basal or squamous cell carcinoma of skin). 8. A new diagnosis of diabetes 9. Positive testing for tuberculosis (QuantiFeron or chest X-ray). 10. Subjects with clinically significant cardiac abnormalities 11. Unable or unwilling to undergo multiple venipunctures 12. Unable to undergo MRI scans due to newly acquired claustrophobia or metallic implants incompatible with MRI. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments | 97 weeks | Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Patients With Relapses to End of Study (EOS) (All Subjects) | week 97 | Description: number of relapses based on neurological assessments and EDSS |
| Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI | weeks 13,25,37,53,73 and 97 | Measures of absolute number of gadolinium \[Gd\]-enhancing lesions on T1-weighted scans |
| Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI | weeks 13,25,37,53,73 and 97 | Measures of absolute number of gadolinium \[Gd\]-enhancing lesions on T2-weighted lesions |
| Change in Brain Volume at End of Study. | week 97 | Change in volume from start to end of study |
| Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline to week 97 | The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. |
Countries
Czechia, Russia, Ukraine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AIN457/ AIN457 AIN in core study , continued AIN in extension study | 22 |
| Placebo/AIN457 Placebo for core study and AIN in extension study | 17 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | AIN457/ AIN457 | Placebo/AIN457 | Total |
|---|---|---|---|
| Age, Continuous | 36.1 Years STANDARD_DEVIATION 10 | 34.2 Years STANDARD_DEVIATION 8.71 | 35.3 Years STANDARD_DEVIATION 9.39 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 16 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 17 | 7 / 22 |
| serious Total, serious adverse events | 0 / 17 | 2 / 22 |
Outcome results
Primary
Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments
Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome
Time frame: 97 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN/AIN | Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments | 12 participants |
| PBO/AIN | Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments | 8 participants |
Secondary
Change in Brain Volume at End of Study.
Change in volume from start to end of study
Time frame: week 97
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIN/AIN | Change in Brain Volume at End of Study. | -14.8968 ml | Standard Deviation 63.73027 |
| PBO/AIN | Change in Brain Volume at End of Study. | -30.4346 ml | Standard Deviation 31.218 |
Secondary
Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)
Description: number of relapses based on neurological assessments and EDSS
Time frame: week 97
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN/AIN | Distribution of Patients With Relapses to End of Study (EOS) (All Subjects) | 9 Participants |
| PBO/AIN | Distribution of Patients With Relapses to End of Study (EOS) (All Subjects) | 5 Participants |
Secondary
Measure of Disability: Expanded Disability Status Scale (EDSS).
The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions.
Time frame: Baseline to week 97
Population: Not all patients may have been available at all time points for EDSS evaluation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 2.0 | 4 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 4.0 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 3.0 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 2.0 | 4 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 3.5 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 2.5 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 4.0 | 0 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 2.5 | 2 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 5.0 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 4.5 | 2 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 5.5 | 2 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 3.0 | 2 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 6.0 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 1.0 | 0 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK73 score 0 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 4.0 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK73 score 1.0 | 2 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 5.0 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK73 score 1.5 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 4.5 | 3 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK73 score 2.0 | 2 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 3.0 | 2 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK73 score 3.0 | 0 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 5.0 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK73 score 4.0 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 6.0 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK73 score 5.5 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 5.5 | 0 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK73 score 6.0 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 2.0 | 5 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 0 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 6.0 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score1.0 | 2 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 0 | 2 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 1.5 | 2 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 6.5 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 2.0 | 2 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 3.5 | 2 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 2.5 | 2 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 0 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 3.0 | 0 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 1 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 3.5 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 1.0 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 4.0 | 2 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 1.5 | 5 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 4.5 | 0 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 1.5 | 3 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 5.5 | 0 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 1.5 | 4 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 6.0 | 1 participants |
| AIN/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 0 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 6.0 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 0 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 1.0 | 2 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 1.5 | 5 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 2.0 | 2 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 2.5 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 3.0 | 4 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 3.5 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 4.0 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 4.5 | 2 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 5.0 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Baseline score 6.0 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 0 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 1 | 2 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 1.5 | 5 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 2.0 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 2.5 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 3.0 | 4 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 4.0 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 4.5 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 5.0 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 5.5 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 6.0 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK25 score 6.5 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 0 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 1.0 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 1.5 | 3 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 2.0 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 3.0 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 3.5 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 4.0 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 5.0 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 5.5 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | Safety Week 53 score 6.0 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK73 score 0 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK73 score 1.0 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK73 score 1.5 | 5 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK73 score 2.0 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK73 score 3.0 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK73 score 4.0 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK73 score 5.5 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | WK73 score 6.0 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 0 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score1.0 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 1.5 | 5 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 2.0 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 2.5 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 3.0 | 3 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 3.5 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 4.0 | 0 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 4.5 | 1 participants |
| PBO/AIN | Measure of Disability: Expanded Disability Status Scale (EDSS). | End of treatment score 5.5 | 1 participants |
Secondary
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI
Measures of absolute number of gadolinium \[Gd\]-enhancing lesions on T1-weighted scans
Time frame: weeks 13,25,37,53,73 and 97
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| AIN/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI | week 13 T1 (n=22, 16) | 0.8 lesions |
| AIN/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI | week 25 T1 (n=22, 16) | 0.6 lesions |
| AIN/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI | week 37 T1 (n=22, 15) | 1.0 lesions |
| AIN/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI | week 53 T1 (n=14, 6) | 0.3 lesions |
| AIN/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI | wk 73 T1 (n=11,9) | 0.6 lesions |
| AIN/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI | EOT (n=15,13) | 0.7 lesions |
| PBO/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI | wk 73 T1 (n=11,9) | 0.2 lesions |
| PBO/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI | week 13 T1 (n=22, 16) | 2.0 lesions |
| PBO/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI | week 53 T1 (n=14, 6) | 0.3 lesions |
| PBO/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI | week 25 T1 (n=22, 16) | 1.9 lesions |
| PBO/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI | EOT (n=15,13) | 0.5 lesions |
| PBO/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI | week 37 T1 (n=22, 15) | 0.8 lesions |
Secondary
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI
Measures of absolute number of gadolinium \[Gd\]-enhancing lesions on T2-weighted lesions
Time frame: weeks 13,25,37,53,73 and 97
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| AIN/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI | week 13 T2 (n=22, 16) | 1.3 lesions |
| AIN/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI | week 25 T2 (n=22, 16) | 0.8 lesions |
| AIN/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI | week 37 T2 (n=22, 15) | 1.3 lesions |
| AIN/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI | week 53 T2 (n=14, 6) | 0.4 lesions |
| AIN/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI | wk 73 T2 (n=11,9) | 1.3 lesions |
| AIN/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI | EOT T2 (n=15,13) | 1.1 lesions |
| PBO/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI | wk 73 T2 (n=11,9) | 0.9 lesions |
| PBO/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI | week 13 T2 (n=22, 16) | 2.2 lesions |
| PBO/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI | week 53 T2 (n=14, 6) | 0.7 lesions |
| PBO/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI | week 25 T2 (n=22, 16) | 2.4 lesions |
| PBO/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI | EOT T2 (n=15,13) | .07 lesions |
| PBO/AIN | Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI | week 37 T2 (n=22, 15) | 1.3 lesions |