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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01497262
First received: December 5, 2011
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Multiple Sclerosis
Drug: Fingolimod
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • The incidence rate of adverse events (AEs and SAEs) [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]

    The incidence of AEs (new or worsened from baseline) and suspected study drug related AEs or developed into an SAE after the start of the treatment will be summarized as the frequency count as well as the percentage of patients with AEs by primary system organ class (SOC), preferred term, severity and relationship to study drug.

    In addition, the incidence of death, SAEs (including infections), AEs (including infections) leading to premature discontinuation of study drug, and other significant AEs will be summarized separately by primary system organ class and preferred term.



Secondary Outcome Measures:
  • Incidence of cardiovascular (bradyarrhythmias and blood pressure increase) events during the first dose administration [ Time Frame: 1,2,3,4,5 and 6 hours ] [ Designated as safety issue: Yes ]

    Incidence of bradyarrhythmias will be assessed based on the AEs. Summary statistics for the incidence of bradyarrhythmias will be reported with the primary analyses.

    Incidence of bradyarrhythmias will be assessed up to 6 hours post initial dose. Incidence of blood pressure increase will be assessed using data from the vital signs. The frequencies and percentages of patients with blood pressure increase will be summarized.


  • Incidence of liver transaminase elevations [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
    Incidence of liver transaminase elevations will be assessed using data from liver function tests. The frequencies and percentages of patients with elevations of 1, 2, 3, 5, and 10 times of the upper limit of normal will be summarized.

  • Incidence of infections [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
    Incidence of all infections will be assessed based on the AEs. Summary statistics for the incidence of infections will be reported within the primary analyses. Infections will be summarized separately by preferred term.

  • Percentage of patient developing macular edema during the study [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: Yes ]
    The incidence of macular edema will be assessed using data from the ophthalmic assessments (including, but not limited to, best-corrected visual acuity, dilated ophthalmoscopy, fundus examination, FA and OCT), and will be summarized as frequency distributions.


Enrollment: 162
Study Start Date: February 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497262

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, A4400BKZ
Novartis Investigative Site
Salta, Argentina, A4400ANG
Brazil
Novartis Investigative Site
Rio de Janeiro, RJ, Brazil, 21941-590
Novartis Investigative Site
Rio de Janeiro, RJ, Brazil, 20270-004
Novartis Investigative Site
Porto Alegre, RS, Brazil, 90610-000
Novartis Investigative Site
Porto Alegre, RS, Brazil, 90020-090
Colombia
Novartis Investigative Site
Barranquilla, Atlantico, Colombia
Novartis Investigative Site
Bogotá, Cundinamarca, Colombia, 110111
Novartis Investigative Site
Bogotá, Colombia
Novartis Investigative Site
Bogotá, Colombia, 00000
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, 59100
Novartis Investigative Site
Kuala Lumpur, Malaysia, 50586
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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01497262     History of Changes
Other Study ID Numbers: CFTY720D2325
Study First Received: December 5, 2011
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration
Brazil: Ministry of Health
Argentina: Ministry of Health
Colombia: Institutional Review Board
Jordan: Ethical Committee
Malaysia: Ministry of Health
Mexico: Ministry of Health
Panama: Ministry of Health
Peru: Ministry of Health

Keywords provided by Novartis:
Multiple Sclerosis
Relapsing-Remitting

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Fingolimod
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014