Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Drug: Fingolimod	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	162 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A 4-month, Open-label, Multi-center Study to Explore the Safety and Tolerability of Fingolimod 0.5 mg in Patients With Relapsing-remitting Multiple Sclerosis
Study Start Date :	February 2012
Actual Primary Completion Date :	April 2014
Actual Study Completion Date :	April 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Fingolimod; Open-label fingolimod 0.5 mg, taken orally once daily for 4 months	Drug: Fingolimod; Fingolimod will be supplied as 0.5mg capsules in bottles of 35.

Outcome Measures

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Primary Outcome Measures :

1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 28 weeks ]
   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

Secondary Outcome Measures :

1. Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema. [ Time Frame: 4 months ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Patients with relapsing remitting Multiple Sclerosis
• Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.

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:

  • systemic corticosteroids or immunoglobulins within 1 month prior to baseline;
  • immunosuppressive medications within 3 months prior to baseline;
  • monoclonal antibodies within 3 months prior to baseline;
  • cladribine, mitoxantrone or alemtuzumab at any time.
• 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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Argentina
Novartis Investigative Site
Caba, Buenos Aires, Argentina, 1425
Novartis Investigative Site
Guaymallen, Mendoza, Argentina, M5507XAD
Novartis Investigative Site
San Miguel de Tucuman, Tucumán, Argentina, T4000DPB
Novartis Investigative Site
San Miguel de Tucumán, Tucumán, Argentina, 4000
Novartis Investigative Site
Cordoba, Argentina, X5004CDT
Novartis Investigative Site
Salta, Argentina, A4400ANG
Novartis Investigative Site
Salta, Argentina, A4400BKZ
Brazil
Novartis Investigative Site
Rio de Janeiro, RJ, Brazil, 20270-004
Novartis Investigative Site
Rio de Janeiro, RJ, Brazil, 21941-590
Novartis Investigative Site
Porto Alegre, RS, Brazil, 90610-000
Colombia
Novartis Investigative Site
Barranquilla, Atlantico, Colombia
Novartis Investigative Site
Bogotá, Cundinamarca, Colombia, 110111
Novartis Investigative Site
Bogotá, Colombia, 00000
Novartis Investigative Site
Bogotá, Colombia
Novartis Investigative Site
Cali, Colombia
Jordan
Novartis Investigative Site
Amman, Jordan, 11942
Novartis Investigative Site
Irbid, Jordan, 22110
Malaysia
Novartis Investigative Site
Kuala Lumpur, Malaysia, 50586
Novartis Investigative Site
Kuala Lumpur, Malaysia, 59100
Novartis Investigative Site
Penang, Malaysia, 10990
Mexico
Novartis Investigative Site
Mexico, Distrito Federal, Mexico, 06700
Novartis Investigative Site
México, Distrito Federal, Mexico, 10700
Novartis Investigative Site
Monterrey, Nuevo León, Mexico, 64060
Novartis Investigative Site
San Nicolas De Los Garza, Nuevo León, Mexico, 66480
Novartis Investigative Site
San Luis Potosí, Mexico, 78240
Panama
Novartis Investigative Site
Panama City, Panamá, Panama
Peru
Novartis Investigative Site
La Perla, Callao, Peru, 04
Novartis Investigative Site
Jesus Maria, Lima, Peru, 11
Novartis Investigative Site
San Isidro, Lima, Peru, 27

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ordoñez-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. Erratum in: Adv Ther. 2015 Jul;32(7):636.

Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01497262 History of Changes
Other Study ID Numbers:	CFTY720D2325
First Posted:	December 22, 2011
Results First Posted:	March 19, 2015
Last Update Posted:	March 19, 2015
Last Verified:	March 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Multiple Sclerosis; Relapsing-Remitting

Additional relevant MeSH terms:

Sclerosis; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases	Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Fingolimod Hydrochloride; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs