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This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data in Multiple Sclerosis (MS) patient population that closely resembles the clinical population seen in routine medical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fingolimod | Experimental | Open-label fingolimod 0.5 mg, taken orally once daily for 4 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fingolimod | Drug | Fingolimod will be supplied as 0.5mg capsules in bottles of 35. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity | 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema. | The incidence of events in special areas of safety interest (including bradyarrhythmias, BP increase, liver function, infections and macular oedema) were assessed by the nature and frequency of AE reporting. These areas of special interest have been identified and potential risks of fingolimod based on knowledge from clinical trials and post-marketing reporting. |
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Inclusion Criteria:
Exclusion Criteria:
Patients with MS other than relapsing remitting MS
Patients with a history of chronic disease of the immune system other than MS, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome.
Patients who have been treated with:
Uncontrolled diabetes mellitus at screening
Diagnosis of macular edema during Screening Phase
Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
Patients who have received total lymphoid irradiation or bone marrow transplantation.
Patients with certain cardiovascular conditions and/or findings in the screening ECG
Patients with certain liver conditions
Pregnant confirmed by a positive pregnancy test t or nursing (lactating) women
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 | Caba | Buenos Aires | 1425 | Argentina | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26170105 | Derived | Ordonez-Boschetti L, Rey R, Cruz A, Sinha A, Reynolds T, Frider N, Alvarenga R. Safety and Tolerability of Fingolimod in Latin American Patients with Relapsing-Remitting Multiple Sclerosis: The Open-Label FIRST LATAM Study. Adv Ther. 2015 Jul;32(7):626-35. doi: 10.1007/s12325-015-0224-2. Epub 2015 Jul 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fingolimod 0.5 mg | Open-label fingolimod 0.5 mg, taken orally once daily for 4 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 4 months |
| Villa Nueva |
| Mendoza Province |
| M5507XAD |
| Argentina |
| Novartis Investigative Site | Salta | Salta Province | A4400ANG | Argentina |
| Novartis Investigative Site | Salta | Salta Province | A4400BKZ | Argentina |
| Novartis Investigative Site | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Novartis Investigative Site | San Miguel de Tucumán | Tucumán Province | T4000DPB | Argentina |
| Novartis Investigative Site | Córdoba | X5004CDT | Argentina |
| Novartis Investigative Site | Rio de Janeiro | Rio de Janeiro | 20270-004 | Brazil |
| Novartis Investigative Site | Rio de Janeiro | Rio de Janeiro | 21941-590 | Brazil |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Novartis Investigative Site | Barranquilla | Atlántico | Colombia |
| Novartis Investigative Site | Bogotá | Cundinamarca | 110111 | Colombia |
| Novartis Investigative Site | Bogotá | 00000 | Colombia |
| Novartis Investigative Site | Bogotá | Colombia |
| Novartis Investigative Site | Cali | Colombia |
| Novartis Investigative Site | Amman | Amman Governorate | 11942 | Jordan |
| Novartis Investigative Site | Irbid | 22110 | Jordan |
| Novartis Investigative Site | Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| Novartis Investigative Site | George Town | Pulau Pinang | 10990 | Malaysia |
| Novartis Investigative Site | Kuala Lumpur | 59100 | Malaysia |
| Novartis Investigative Site | Mexico City | Mexico City | 06700 | Mexico |
| Novartis Investigative Site | Mexico City | Mexico City | 10700 | Mexico |
| Novartis Investigative Site | Monterrey | Nuevo León | 64060 | Mexico |
| Novartis Investigative Site | San Nicolás de los Garza | Nuevo León | 66480 | Mexico |
| Novartis Investigative Site | San Luis Potosà City | San Luis Potosà | 78240 | Mexico |
| Novartis Investigative Site | Panama City | Provincia de Panamá | Panama |
| Novartis Investigative Site | Jesus Maria | Lima region | 11 | Peru |
| Novartis Investigative Site | San Isidro | Lima region | 27 | Peru |
| Novartis Investigative Site | La Perla | Provincia Constitucional del Callao | 04 | Peru |
| COMPLETED |
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| NOT COMPLETED |
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The Enrolled Set (ENR) included all patients who signed the informed consent and enrolled in study
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| ID | Title | Description |
|---|---|---|
| BG000 | Fingolimod 0.5 mg | Open-label fingolimod 0.5 mg, taken orally once daily for 4 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Age, Customized | Number | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema. | The incidence of events in special areas of safety interest (including bradyarrhythmias, BP increase, liver function, infections and macular oedema) were assessed by the nature and frequency of AE reporting. These areas of special interest have been identified and potential risks of fingolimod based on knowledge from clinical trials and post-marketing reporting. | Safety set includes all patients who received at least one dose of study drug | Posted | Number | Percent of Participants | 4 months |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity | Safety set includes all patients who received at least one dose of study drug | Posted | Number | Participants | 28 weeks |
|
|
Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
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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 | Fingolimod 0.5 mg | Open-label fingolimod 0.5 mg, taken orally once daily for 4 months | 12 | 162 | 63 | 162 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 16.1 | 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.
| 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 |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
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| 31-40 years |
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| 41-55 years |
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| 56-65 years |
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| >65 years |
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| Title | Measurements |
|---|---|
|
| Liver Transaminase evaluations |
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| Infections |
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| Macula Oedema |
|
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