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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001629-25 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIN 457 Core | Experimental | (10mg/kg i.v.). AIN 457 core study /AIN 457 Extension |
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| AIN457 Placebo Core | Experimental | (10mg/kg i.v.). AIN 457 placebo core study /AIN 457 Extension |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIN457 | Drug | (10mg/kg i.v.). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 97 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of Patients With Relapses to End of Study (EOS) (All Subjects) | Description: number of relapses based on neurological assessments and EDSS | week 97 |
| Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI |
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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:
Have been treated with:
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.
Have received any live or live attenuated vaccines (including live vaccines for varicella-zoster virus or measles) within 2 months prior to enrollment.
A diagnosis of chronic disease of the immune system other than MS, or of an immunodeficiency syndrome.
Current severe depression.
Pregnant or nursing (lactating) women.
Malignancy diagnosed since enrollment in the core study (except for successfully-treated basal or squamous cell carcinoma of skin).
A new diagnosis of diabetes
Positive testing for tuberculosis (QuantiFeron or chest X-ray).
Subjects with clinically significant cardiac abnormalities
Unable or unwilling to undergo multiple venipunctures
Unable to undergo MRI scans due to newly acquired claustrophobia or metallic implants incompatible with MRI.
Other protocol-defined inclusion/exclusion criteria may apply
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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 Core / AIN457 Extension | AIN in core study , continued AIN in extension study ( 10 mg/Kg iv every four weeks) |
| FG001 | AIN Placebo/ AIN457 Extension | Placebo in core study and AIN in extension study (10 mg/kg iv every four weeks) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| AIN457 | Drug | (10mg/kg i.v.). |
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Measures of absolute number of gadolinium [Gd]-enhancing lesions on T1-weighted scans
| weeks 13,25,37,53,73 and 97 |
| 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 | weeks 13,25,37,53,73 and 97 |
| Change in Brain Volume at End of Study. | Change in volume from start to end of study | week 97 |
| 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. | Baseline to week 97 |
| Ostrava |
| Czechia |
| Novartis Investigative Site | Ostrava-Moravska Ostrava | Czechia |
| Novartis Investigative Site | Prague | 128 08 | 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 | Ukraine |
| Novartis Investigative Site | Odesa | 65025 | Ukraine |
| Novartis Investigative Site | Vinnitsya | 21005 | Ukraine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AIN457/ AIN457 | AIN in core study , continued AIN in extension study |
| BG001 | Placebo/AIN457 | Placebo for core study and AIN in extension study |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| 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 | 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 | Posted | Number | participants | 97 weeks |
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| Secondary | Distribution of Patients With Relapses to End of Study (EOS) (All Subjects) | Description: number of relapses based on neurological assessments and EDSS | Posted | Number | Participants | week 97 |
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| 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 | Posted | Mean | Full Range | lesions | weeks 13,25,37,53,73 and 97 |
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| ||||||||||||||||||||||||||||||
| 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 | Posted | Mean | Full Range | lesions | weeks 13,25,37,53,73 and 97 |
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| Secondary | Change in Brain Volume at End of Study. | Change in volume from start to end of study | Posted | Mean | Standard Deviation | ml | week 97 |
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| 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. | Not all patients may have been available at all time points for EDSS evaluation | Posted | Number | participants | Baseline to week 97 |
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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(Core)/AIN457(Extension) | Placebo(core)/AIN457(extension) | 0 | 17 | 8 | 17 | ||
| EG001 | AIN457(Core)/AIN457(Extension) | AIN457(core)/AIN457(extension) | 2 | 22 | 7 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | MedDRA | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Respiratory tract infection viral | Infections and infestations | MedDRA | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA | Systematic Assessment |
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| Overweight | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
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| Anxiety disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Uterine cervical erosion | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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| Varicose vein | Vascular disorders | MedDRA | Systematic Assessment |
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Further development of secukinumab in MS is not being pursued and the extension study , CAIN457B2201E1, further enrollment stopped . Not completing enrollment of this study was not related to the safety or tolerability concerns observed in 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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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