Trial Outcomes & Findings for POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler (NCT NCT01051817)
NCT ID: NCT01051817
Last Updated: 2015-02-27
Results Overview
Combined unique active lesions (CUAL) observed on brain MRI scans performed every 4th week from week 4 to week 24 in patients with relapsing-remitting multiple sclerosis (RRMS). CUAL is defined as: new gadolinium (Gd)-enhancing lesions on T1-weighted, or new or enlarging lesions on T2-weighted MRI scans, without double counting.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
weeks 4,8,12,16,20,24,28
Results posted on
2015-02-27
Participant Flow
Participant milestones
| Measure |
AIN457
IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20.
|
Placebo
Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
35
|
|
Overall Study
COMPLETED
|
35
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
9
|
Reasons for withdrawal
| Measure |
AIN457
IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20.
|
Placebo
Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Abnormal Test Proceedure reults
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler
Baseline characteristics by cohort
| Measure |
AIN457
n=38 Participants
IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20.
|
Placebo
n=35 Participants
Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.1 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
32.7 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
34.5 years
STANDARD_DEVIATION 9.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: weeks 4,8,12,16,20,24,28Population: Full Analysis Set
Combined unique active lesions (CUAL) observed on brain MRI scans performed every 4th week from week 4 to week 24 in patients with relapsing-remitting multiple sclerosis (RRMS). CUAL is defined as: new gadolinium (Gd)-enhancing lesions on T1-weighted, or new or enlarging lesions on T2-weighted MRI scans, without double counting.
Outcome measures
| Measure |
AIN457B
n=38 Participants
10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20
|
Placebo
n=35 Participants
Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
|
|---|---|---|
|
Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment
Week 4 (n=37,34)
|
2.4 Combined Unique Active Lesions
Interval 0.0 to 33.0
|
3.2 Combined Unique Active Lesions
Interval 0.0 to 16.0
|
|
Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment
Week 8 (n=36, 31)
|
3.9 Combined Unique Active Lesions
Interval 0.0 to 47.0
|
5.4 Combined Unique Active Lesions
Interval 0.0 to 27.0
|
|
Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment
Week 12 (n=35,31)
|
5.4 Combined Unique Active Lesions
Interval 0.0 to 80.0
|
8.6 Combined Unique Active Lesions
Interval 0.0 to 34.0
|
|
Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment
Week 16 (n=32,29)
|
6.0 Combined Unique Active Lesions
Interval 0.0 to 104.0
|
11.5 Combined Unique Active Lesions
Interval 0.0 to 50.0
|
|
Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment
Week 20 (n=34,27)
|
7.7 Combined Unique Active Lesions
Interval 0.0 to 118.0
|
13.0 Combined Unique Active Lesions
Interval 0.0 to 51.0
|
|
Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment
Week 24 (n=32,24)
|
7.7 Combined Unique Active Lesions
Interval 0.0 to 122.0
|
15.1 Combined Unique Active Lesions
Interval 0.0 to 64.0
|
|
Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment
Week 28 (n=32,29)
|
9.4 Combined Unique Active Lesions
Interval 0.0 to 142.0
|
19.9 Combined Unique Active Lesions
Interval 0.0 to 110.0
|
SECONDARY outcome
Timeframe: MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).Population: Full analysis set
The summary of raw number of cumulative new Gadolinium-enhanced T1 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The end-point is week 24.
Outcome measures
| Measure |
AIN457B
n=38 Participants
10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20
|
Placebo
n=35 Participants
Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
|
|---|---|---|
|
Raw Number of Cumulative New Gd-T1 Lesions
Week 4 (n=37,34)
|
1.4 cumulative new Gd-T1 lesions
Interval 0.0 to 31.0
|
1.7 cumulative new Gd-T1 lesions
Interval 0.0 to 12.0
|
|
Raw Number of Cumulative New Gd-T1 Lesions
Week 8 (n= 36,31)
|
2.6 cumulative new Gd-T1 lesions
Interval 0.0 to 44.0
|
3.0 cumulative new Gd-T1 lesions
Interval 0.0 to 16.0
|
|
Raw Number of Cumulative New Gd-T1 Lesions
Week 12 (n=35,31)
|
4.3 cumulative new Gd-T1 lesions
Interval 0.0 to 76.0
|
5.5 cumulative new Gd-T1 lesions
Interval 0.0 to 26.0
|
|
Raw Number of Cumulative New Gd-T1 Lesions
Week 16 (n= 32,29)
|
4.0 cumulative new Gd-T1 lesions
Interval 0.0 to 99.0
|
7.8 cumulative new Gd-T1 lesions
Interval 0.0 to 36.0
|
|
Raw Number of Cumulative New Gd-T1 Lesions
Week 20 (n=34,27)
|
5.6 cumulative new Gd-T1 lesions
Interval 0.0 to 112.0
|
9.2 cumulative new Gd-T1 lesions
Interval 0.0 to 40.0
|
|
Raw Number of Cumulative New Gd-T1 Lesions
Week 24 (n=32,24)
|
5.4 cumulative new Gd-T1 lesions
Interval 0.0 to 116.0
|
11.1 cumulative new Gd-T1 lesions
Interval 0.0 to 55.0
|
|
Raw Number of Cumulative New Gd-T1 Lesions
Week 28 (n=32,29)
|
6.5 cumulative new Gd-T1 lesions
Interval 0.0 to 135.0
|
14.4 cumulative new Gd-T1 lesions
Interval 0.0 to 99.0
|
SECONDARY outcome
Timeframe: MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).Population: full analysis Set
The summary of raw number of cumulative new Gadolinium-enhanced T2 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The endpoint is week 24.
Outcome measures
| Measure |
AIN457B
n=38 Participants
10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20
|
Placebo
n=35 Participants
Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
|
|---|---|---|
|
Raw Number of Cumulative New Gd-T2 Lesions
Week 4 (n= 37,34)
|
2.3 Cumulative new Gd-T2 lesions
Interval 0.0 to 30.0
|
3.1 Cumulative new Gd-T2 lesions
Interval 0.0 to 16.0
|
|
Raw Number of Cumulative New Gd-T2 Lesions
Week 8 (n=36,31)
|
3.6 Cumulative new Gd-T2 lesions
Interval 0.0 to 43.0
|
5.4 Cumulative new Gd-T2 lesions
Interval 0.0 to 28.0
|
|
Raw Number of Cumulative New Gd-T2 Lesions
Week 12 (n=35,31)
|
5.0 Cumulative new Gd-T2 lesions
Interval 0.0 to 72.0
|
8.3 Cumulative new Gd-T2 lesions
Interval 0.0 to 34.0
|
|
Raw Number of Cumulative New Gd-T2 Lesions
Week 16 (n=32,29)
|
5.6 Cumulative new Gd-T2 lesions
Interval 0.0 to 91.0
|
11.0 Cumulative new Gd-T2 lesions
Interval 0.0 to 50.0
|
|
Raw Number of Cumulative New Gd-T2 Lesions
Week 20 (n= 34,27)
|
7.2 Cumulative new Gd-T2 lesions
Interval 0.0 to 106.0
|
12.3 Cumulative new Gd-T2 lesions
Interval 0.0 to 51.0
|
|
Raw Number of Cumulative New Gd-T2 Lesions
Week 24 (n=32,24)
|
7.2 Cumulative new Gd-T2 lesions
Interval 0.0 to 110.0
|
14.6 Cumulative new Gd-T2 lesions
Interval 0.0 to 64.0
|
|
Raw Number of Cumulative New Gd-T2 Lesions
Week 28 (n=32,29)
|
8.8 Cumulative new Gd-T2 lesions
Interval 0.0 to 126.0
|
19.1 Cumulative new Gd-T2 lesions
Interval 0.0 to 110.0
|
Adverse Events
PLACEBO
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
AIN457 10mg/kg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PLACEBO
n=35 participants at risk
PLACEBO
|
AIN457 10mg/kg
n=38 participants at risk
AIN457 10mg/kg
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
5.7%
2/35
|
0.00%
0/38
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/35
|
5.3%
2/38
|
|
Infections and infestations
Oral herpes
|
0.00%
0/35
|
5.3%
2/38
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/35
|
5.3%
2/38
|
|
Infections and infestations
Respiratory tract infection viral
|
5.7%
2/35
|
5.3%
2/38
|
|
Infections and infestations
Viral infection
|
0.00%
0/35
|
5.3%
2/38
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/35
|
5.3%
2/38
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
2/35
|
2.6%
1/38
|
|
Nervous system disorders
Headache
|
8.6%
3/35
|
2.6%
1/38
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/35
|
5.3%
2/38
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/35
|
5.3%
2/38
|
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