POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01051817
Collaborator
(none)
73
16
2
28
4.6
0.2
Study Details
Study Description
Brief Summary
A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
73 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Multi-center, Double-blind, Proof-of-concept Study to Assess the Effect of Multiple Infusion of AIN457 (10 mg/kg) Versus Placebo on Disease Activity as Measured by MRI Scans Over a 24 Week Period in Patients With Relapsing-remitting Multiple Sclerosis
Study Start Date
:
Dec 1, 2009
Actual Primary Completion Date
:
Apr 1, 2012
Actual Study Completion Date
:
Apr 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AIN457
|
Drug: AIN457
infusion 10 mg/Kg
|
| Placebo Comparator: Placebo
|
Drug: Placebo
infusion
|
Outcome Measures
Primary Outcome Measures
- Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment [weeks 4,8,12,16,20,24,28]
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.
Secondary Outcome Measures
- Raw Number of Cumulative New Gd-T1 Lesions [MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).]
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.
- Raw Number of Cumulative New Gd-T2 Lesions [MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Hradec Kralove | Czech Republic | 500 05 | |
| 2 | Novartis Investigative Site | Ostrava-Moravska Ostrava | Czech Republic | ||
| 3 | Novartis Investigative Site | Ostrava | Czech Republic | ||
| 4 | Novartis Investigative Site | Praha 10 | Czech Republic | ||
| 5 | Novartis Investigative Site | Praha 2 | Czech Republic | 128 08 | |
| 6 | Novartis Investigative Site | Teplice | Czech Republic | 415 29 | |
| 7 | Novartis Investigative Site | Kazan | Russian Federation | 420021 | |
| 8 | Novartis Investigative Site | Moscow | Russian Federation | 129128 | |
| 9 | Novartis Investigative Site | Nizhny Novgorod | Russian Federation | 603155 | |
| 10 | Novartis Investigative Site | Smolensk | Russian Federation | 214019 | |
| 11 | Novartis Investigative Site | Kharkiv | Ukraine | 61068 | |
| 12 | Novartis Investigative Site | Kharkiv | Ukraine | ||
| 13 | Novartis Investigative Site | Kiev | Ukraine | 03110 | |
| 14 | Novartis Investigative Site | Kiev | Ukraine | ||
| 15 | Novartis Investigative Site | Odessa | Ukraine | 65025 | |
| 16 | Novartis Investigative Site | Vinnitsya | Ukraine | 21005 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01051817
Other Study ID Numbers:
- CAIN457B2201
- 2009-011626-34
First Posted:
Jan 20, 2010
Last Update Posted:
Feb 27, 2015
Last Verified:
Feb 1, 2015
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | AIN457 | Placebo |
|---|---|---|
| Arm/Group Description | IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20. | Placebo IV week 0, 2, 4, 8, 12, 16, and 20. |
| Period Title: Overall Study | ||
| STARTED | 38 | 35 |
| COMPLETED | 35 | 26 |
| NOT COMPLETED | 3 | 9 |
Baseline Characteristics
| Arm/Group Title | AIN457 | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20. | Placebo IV week 0, 2, 4, 8, 12, 16, and 20. | Total of all reporting groups |
| Overall Participants | 38 | 35 | 73 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
36.1
(9.8)
|
32.7
(9.9)
|
34.5
(9.95)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
21
55.3%
|
29
82.9%
|
50
68.5%
|
| Male |
17
44.7%
|
6
17.1%
|
23
31.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
3
7.9%
|
1
2.9%
|
4
5.5%
|
| Not Hispanic or Latino |
35
92.1%
|
34
97.1%
|
69
94.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
36
94.7%
|
33
94.3%
|
69
94.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
2
5.3%
|
2
5.7%
|
4
5.5%
|
Outcome Measures
| Title | Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment |
|---|---|
| Description | 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. |
| Time Frame | weeks 4,8,12,16,20,24,28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | AIN457B | Placebo |
|---|---|---|
| Arm/Group Description | 10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20 | Placebo IV week 0, 2, 4, 8, 12, 16, and 20. |
| Measure Participants | 38 | 35 |
| Week 4 (n=37,34) |
2.4
|
3.2
|
| Week 8 (n=36, 31) |
3.9
|
5.4
|
| Week 12 (n=35,31) |
5.4
|
8.6
|
| Week 16 (n=32,29) |
6.0
|
11.5
|
| Week 20 (n=34,27) |
7.7
|
13.0
|
| Week 24 (n=32,24) |
7.7
|
15.1
|
| Week 28 (n=32,29) |
9.4
|
19.9
|
| Title | Raw Number of Cumulative New Gd-T1 Lesions |
|---|---|
| Description | 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. |
| Time Frame | MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set |
| Arm/Group Title | AIN457B | Placebo |
|---|---|---|
| Arm/Group Description | 10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20 | Placebo IV week 0, 2, 4, 8, 12, 16, and 20. |
| Measure Participants | 38 | 35 |
| Week 4 (n=37,34) |
1.4
|
1.7
|
| Week 8 (n= 36,31) |
2.6
|
3.0
|
| Week 12 (n=35,31) |
4.3
|
5.5
|
| Week 16 (n= 32,29) |
4.0
|
7.8
|
| Week 20 (n=34,27) |
5.6
|
9.2
|
| Week 24 (n=32,24) |
5.4
|
11.1
|
| Week 28 (n=32,29) |
6.5
|
14.4
|
| Title | Raw Number of Cumulative New Gd-T2 Lesions |
|---|---|
| Description | 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. |
| Time Frame | MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS). |
Outcome Measure Data
| Analysis Population Description |
|---|
| full analysis Set |
| Arm/Group Title | AIN457B | Placebo |
|---|---|---|
| Arm/Group Description | 10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20 | Placebo IV week 0, 2, 4, 8, 12, 16, and 20. |
| Measure Participants | 38 | 35 |
| Week 4 (n= 37,34) |
2.3
|
3.1
|
| Week 8 (n=36,31) |
3.6
|
5.4
|
| Week 12 (n=35,31) |
5.0
|
8.3
|
| Week 16 (n=32,29) |
5.6
|
11.0
|
| Week 20 (n= 34,27) |
7.2
|
12.3
|
| Week 24 (n=32,24) |
7.2
|
14.6
|
| Week 28 (n=32,29) |
8.8
|
19.1
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | PLACEBO | AIN457 10mg/kg | ||
| Arm/Group Description | PLACEBO | AIN457 10mg/kg | ||
All Cause Mortality |
||||
| PLACEBO | AIN457 10mg/kg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| PLACEBO | AIN457 10mg/kg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/35 (0%) | 0/38 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| PLACEBO | AIN457 10mg/kg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/35 (20%) | 13/38 (34.2%) | ||
| Blood and lymphatic system disorders | ||||
| Leukopenia | 2/35 (5.7%) | 0/38 (0%) | ||
| Gastrointestinal disorders | ||||
| Dyspepsia | 0/35 (0%) | 2/38 (5.3%) | ||
| Infections and infestations | ||||
| Oral herpes | 0/35 (0%) | 2/38 (5.3%) | ||
| Pharyngitis | 0/35 (0%) | 2/38 (5.3%) | ||
| Respiratory tract infection viral | 2/35 (5.7%) | 2/38 (5.3%) | ||
| Viral infection | 0/35 (0%) | 2/38 (5.3%) | ||
| Injury, poisoning and procedural complications | ||||
| Contusion | 0/35 (0%) | 2/38 (5.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 2/35 (5.7%) | 1/38 (2.6%) | ||
| Nervous system disorders | ||||
| Headache | 3/35 (8.6%) | 1/38 (2.6%) | ||
| Paraesthesia | 0/35 (0%) | 2/38 (5.3%) | ||
| Psychiatric disorders | ||||
| Anxiety | 0/35 (0%) | 2/38 (5.3%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862-778-8300 |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01051817
Other Study ID Numbers:
- CAIN457B2201
- 2009-011626-34
First Posted:
Jan 20, 2010
Last Update Posted:
Feb 27, 2015
Last Verified:
Feb 1, 2015