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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011626-34 |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIN457 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIN457 | Drug | infusion 10 mg/Kg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment | 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. | weeks 4,8,12,16,20,24,28 |
| Measure | Description | Time Frame |
|---|---|---|
| Raw Number of Cumulative New Gd-T1 Lesions | 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. | MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS). |
| Raw Number of Cumulative New Gd-T2 Lesions |
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Inclusion Criteria:
-
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Hradec Králové | Czech Republic | 500 05 | Czechia | ||
| Novartis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | AIN457 | IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20. |
| FG001 | Placebo | Placebo IV week 0, 2, 4, 8, 12, 16, and 20. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AIN457 | IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20. |
| BG001 | Placebo | Placebo IV week 0, 2, 4, 8, 12, 16, and 20. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment | 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. | Full Analysis Set | Posted | Mean | Full Range | Combined Unique Active Lesions | weeks 4,8,12,16,20,24,28 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PLACEBO | PLACEBO |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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| Drug |
infusion |
|
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. |
| MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS). |
| Ostrava |
| Czechia |
| Novartis Investigative Site | Ostrava-Moravska Ostrava | Czechia |
| Novartis Investigative Site | Prague | 128 08 | Czechia |
| Novartis Investigative Site | Prague | Czechia |
| Novartis Investigative Site | Teplice | 415 29 | Czechia |
| Novartis Investigative Site | Kazan' | 420021 | Russia |
| Novartis Investigative Site | Moscow | 129128 | Russia |
| Novartis Investigative Site | Nizhny Novgorod | 603155 | Russia |
| Novartis Investigative Site | Smolensk | 214019 | Russia |
| Novartis Investigative Site | Kharkiv | 61068 | Ukraine |
| Novartis Investigative Site | Kharkiv | Ukraine |
| Novartis Investigative Site | Kiev | 03110 | Ukraine |
| Novartis Investigative Site | Kiev | Ukraine |
| Novartis Investigative Site | Odesa | 65025 | Ukraine |
| Novartis Investigative Site | Vinnitsya | 21005 | Ukraine |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
|
|
| Secondary | Raw Number of Cumulative New Gd-T1 Lesions | 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. | Full analysis set | Posted | Mean | Full Range | cumulative new Gd-T1 lesions | MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS). |
|
|
|
| Secondary | Raw Number of Cumulative New Gd-T2 Lesions | 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. | full analysis Set | Posted | Mean | Full Range | Cumulative new Gd-T2 lesions | MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS). |
|
|
|
| 0 |
| 35 |
| 7 |
| 35 |
| EG001 | AIN457 10mg/kg | AIN457 10mg/kg | 0 | 38 | 13 | 38 |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
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
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Week 12 (n=35,31) |
|
| Week 16 (n= 32,29) |
|
| Week 20 (n=34,27) |
|
| Week 24 (n=32,24) |
|
| Week 28 (n=32,29) |
|
| Week 12 (n=35,31) |
|
| Week 16 (n=32,29) |
|
| Week 20 (n= 34,27) |
|
| Week 24 (n=32,24) |
|
| Week 28 (n=32,29) |
|