Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis (NCT NCT01433250)
NCT ID: NCT01433250
Last Updated: 2016-03-14
Results Overview
Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
97 weeks
Results posted on
2016-03-14
Participant Flow
Participant milestones
| Measure |
AIN457 Core / AIN457 Extension
AIN in core study , continued AIN in extension study ( 10 mg/Kg iv every four weeks)
|
AIN Placebo/ AIN457 Extension
Placebo in core study and AIN in extension study
(10 mg/kg iv every four weeks)
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
17
|
|
Overall Study
COMPLETED
|
19
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
AIN457 Core / AIN457 Extension
AIN in core study , continued AIN in extension study ( 10 mg/Kg iv every four weeks)
|
AIN Placebo/ AIN457 Extension
Placebo in core study and AIN in extension study
(10 mg/kg iv every four weeks)
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
AIN457/ AIN457
n=22 Participants
AIN in core study , continued AIN in extension study
|
Placebo/AIN457
n=17 Participants
Placebo for core study and AIN in extension study
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.1 Years
STANDARD_DEVIATION 10 • n=5 Participants
|
34.2 Years
STANDARD_DEVIATION 8.71 • n=7 Participants
|
35.3 Years
STANDARD_DEVIATION 9.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 97 weeksSafety outcomes will be described in Adverse events section as there was not an efficacy primary outcome
Outcome measures
| Measure |
AIN/AIN
n=22 Participants
AIN core 24 weeks/AIN extension 1 year
|
PBO/AIN
n=17 Participants
placebo first 24 weeks/ AIN extension for 52 weeks
|
|---|---|---|
|
Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments
|
12 participants
|
8 participants
|
SECONDARY outcome
Timeframe: week 97Description: number of relapses based on neurological assessments and EDSS
Outcome measures
| Measure |
AIN/AIN
n=22 Participants
AIN core 24 weeks/AIN extension 1 year
|
PBO/AIN
n=17 Participants
placebo first 24 weeks/ AIN extension for 52 weeks
|
|---|---|---|
|
Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: weeks 13,25,37,53,73 and 97Measures of absolute number of gadolinium \[Gd\]-enhancing lesions on T1-weighted scans
Outcome measures
| Measure |
AIN/AIN
n=22 Participants
AIN core 24 weeks/AIN extension 1 year
|
PBO/AIN
n=17 Participants
placebo first 24 weeks/ AIN extension for 52 weeks
|
|---|---|---|
|
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI
week 13 T1 (n=22, 16)
|
0.8 lesions
Interval 0.0 to 4.0
|
2.0 lesions
Interval 0.0 to 15.0
|
|
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI
week 25 T1 (n=22, 16)
|
0.6 lesions
Interval 0.0 to 5.0
|
1.9 lesions
Interval 0.0 to 20.0
|
|
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI
week 37 T1 (n=22, 15)
|
1.0 lesions
Interval 0.0 to 5.0
|
0.8 lesions
Interval 0.0 to 4.0
|
|
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI
week 53 T1 (n=14, 6)
|
0.3 lesions
Interval 0.0 to 3.0
|
0.3 lesions
Interval 0.0 to 1.0
|
|
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI
wk 73 T1 (n=11,9)
|
0.6 lesions
Interval 0.0 to 3.0
|
0.2 lesions
Interval 0.0 to 1.0
|
|
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI
EOT (n=15,13)
|
0.7 lesions
Interval 0.0 to 5.0
|
0.5 lesions
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: weeks 13,25,37,53,73 and 97Measures of absolute number of gadolinium \[Gd\]-enhancing lesions on T2-weighted lesions
Outcome measures
| Measure |
AIN/AIN
n=22 Participants
AIN core 24 weeks/AIN extension 1 year
|
PBO/AIN
n=17 Participants
placebo first 24 weeks/ AIN extension for 52 weeks
|
|---|---|---|
|
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI
week 13 T2 (n=22, 16)
|
1.3 lesions
Interval 0.0 to 7.0
|
2.2 lesions
Interval 0.0 to 12.0
|
|
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI
week 25 T2 (n=22, 16)
|
0.8 lesions
Interval 0.0 to 6.0
|
2.4 lesions
Interval 0.0 to 21.0
|
|
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI
week 37 T2 (n=22, 15)
|
1.3 lesions
Interval 0.0 to 5.0
|
1.3 lesions
Interval 0.0 to 6.0
|
|
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI
week 53 T2 (n=14, 6)
|
0.4 lesions
Interval 0.0 to 4.0
|
0.7 lesions
Interval 0.0 to 3.0
|
|
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI
wk 73 T2 (n=11,9)
|
1.3 lesions
Interval 0.0 to 5.0
|
0.9 lesions
Interval 0.0 to 5.0
|
|
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI
EOT T2 (n=15,13)
|
1.1 lesions
Interval 0.0 to 4.0
|
.07 lesions
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: week 97Change in volume from start to end of study
Outcome measures
| Measure |
AIN/AIN
n=22 Participants
AIN core 24 weeks/AIN extension 1 year
|
PBO/AIN
n=17 Participants
placebo first 24 weeks/ AIN extension for 52 weeks
|
|---|---|---|
|
Change in Brain Volume at End of Study.
|
-14.8968 ml
Standard Deviation 63.73027
|
-30.4346 ml
Standard Deviation 31.21800
|
SECONDARY outcome
Timeframe: Baseline to week 97Population: Not all patients may have been available at all time points for EDSS evaluation
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.
Outcome measures
| Measure |
AIN/AIN
n=22 Participants
AIN core 24 weeks/AIN extension 1 year
|
PBO/AIN
n=17 Participants
placebo first 24 weeks/ AIN extension for 52 weeks
|
|---|---|---|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Baseline score 0
|
1 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Baseline score 2.5
|
1 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Baseline score 3.5
|
2 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Baseline score 4.0
|
1 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Baseline score 4.5
|
2 participants
|
2 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK25 score 0
|
2 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK25 score 4.5
|
3 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Safety Week 53 score 1.5
|
3 participants
|
3 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Safety Week 53 score 3.5
|
1 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK73 score 2.0
|
2 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
End of treatment score 1.5
|
2 participants
|
5 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
End of treatment score 2.0
|
2 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
End of treatment score 4.0
|
2 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Baseline score 5.0
|
1 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Baseline score 1.0
|
0 participants
|
2 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Baseline score 1.5
|
5 participants
|
5 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Baseline score 2.0
|
5 participants
|
2 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Baseline score 3.0
|
2 participants
|
4 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Baseline score 6.0
|
1 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK25 score 1
|
1 participants
|
2 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK25 score 1.5
|
4 participants
|
5 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK25 score 2.0
|
4 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK25 score 2.5
|
2 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK25 score 3.0
|
2 participants
|
4 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK25 score 4.0
|
1 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK25 score 5.0
|
1 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK25 score 5.5
|
0 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK25 score 6.0
|
1 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK25 score 6.5
|
1 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Safety Week 53 score 0
|
1 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Safety Week 53 score 1.0
|
1 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Safety Week 53 score 2.0
|
4 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Safety Week 53 score 3.0
|
1 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Safety Week 53 score 4.0
|
0 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Safety Week 53 score 5.0
|
1 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Safety Week 53 score 5.5
|
2 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
Safety Week 53 score 6.0
|
1 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK73 score 0
|
1 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK73 score 1.0
|
2 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK73 score 1.5
|
1 participants
|
5 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK73 score 3.0
|
0 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK73 score 4.0
|
1 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK73 score 5.5
|
1 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
End of treatment score 3.0
|
0 participants
|
3 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
End of treatment score 3.5
|
1 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
End of treatment score 4.5
|
0 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
End of treatment score 5.5
|
0 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
End of treatment score 6.0
|
1 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
WK73 score 6.0
|
1 participants
|
0 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
End of treatment score 0
|
1 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
End of treatment score1.0
|
2 participants
|
1 participants
|
|
Measure of Disability: Expanded Disability Status Scale (EDSS).
End of treatment score 2.5
|
2 participants
|
1 participants
|
Adverse Events
Placebo(Core)/AIN457(Extension)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
AIN457(Core)/AIN457(Extension)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo(Core)/AIN457(Extension)
n=17 participants at risk
Placebo(core)/AIN457(extension)
|
AIN457(Core)/AIN457(Extension)
n=22 participants at risk
AIN457(core)/AIN457(extension)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/17
|
4.5%
1/22
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/17
|
4.5%
1/22
|
Other adverse events
| Measure |
Placebo(Core)/AIN457(Extension)
n=17 participants at risk
Placebo(core)/AIN457(extension)
|
AIN457(Core)/AIN457(Extension)
n=22 participants at risk
AIN457(core)/AIN457(extension)
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
5.9%
1/17
|
0.00%
0/22
|
|
Cardiac disorders
Cardiomyopathy
|
5.9%
1/17
|
0.00%
0/22
|
|
Gastrointestinal disorders
Gastritis
|
5.9%
1/17
|
0.00%
0/22
|
|
Infections and infestations
Cystitis
|
5.9%
1/17
|
0.00%
0/22
|
|
Infections and infestations
Laryngitis
|
5.9%
1/17
|
0.00%
0/22
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
1/17
|
4.5%
1/22
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/17
|
9.1%
2/22
|
|
Infections and infestations
Respiratory tract infection viral
|
5.9%
1/17
|
9.1%
2/22
|
|
Infections and infestations
Rhinitis
|
5.9%
1/17
|
0.00%
0/22
|
|
Investigations
C-reactive protein increased
|
5.9%
1/17
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Overweight
|
5.9%
1/17
|
0.00%
0/22
|
|
Nervous system disorders
Headache
|
5.9%
1/17
|
0.00%
0/22
|
|
Nervous system disorders
Migraine
|
5.9%
1/17
|
0.00%
0/22
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/17
|
9.1%
2/22
|
|
Reproductive system and breast disorders
Uterine cervical erosion
|
5.9%
1/17
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17
|
9.1%
2/22
|
|
Vascular disorders
Hypertension
|
5.9%
1/17
|
0.00%
0/22
|
|
Vascular disorders
Varicose vein
|
0.00%
0/17
|
9.1%
2/22
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial
- Publication restrictions are in place
Restriction type: OTHER