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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fingolimod
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fingolimod

Arm Description

Open-label fingolimod 0.5 mg, taken orally once daily for 4 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
December 5, 2011
Last Updated
March 17, 2015
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01497262
Brief Title
Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
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 Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Relapsing-Remitting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fingolimod
Arm Type
Experimental
Arm Description
Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
Intervention Type
Drug
Intervention Name(s)
Fingolimod
Intervention Description
Fingolimod will be supplied as 0.5mg capsules in bottles of 35.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description
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
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Novartis Investigative Site
City
Guaymallen
State/Province
Mendoza
ZIP/Postal Code
M5507XAD
Country
Argentina
Facility Name
Novartis Investigative Site
City
San Miguel de Tucuman
State/Province
Tucumán
ZIP/Postal Code
T4000DPB
Country
Argentina
Facility Name
Novartis Investigative Site
City
San Miguel de Tucumán
State/Province
Tucumán
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Novartis Investigative Site
City
Cordoba
ZIP/Postal Code
X5004CDT
Country
Argentina
Facility Name
Novartis Investigative Site
City
Salta
ZIP/Postal Code
A4400ANG
Country
Argentina
Facility Name
Novartis Investigative Site
City
Salta
ZIP/Postal Code
A4400BKZ
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20270-004
Country
Brazil
Facility Name
Novartis Investigative Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-590
Country
Brazil
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Novartis Investigative Site
City
Bogotá
State/Province
Cundinamarca
ZIP/Postal Code
110111
Country
Colombia
Facility Name
Novartis Investigative Site
City
Bogotá
ZIP/Postal Code
00000
Country
Colombia
Facility Name
Novartis Investigative Site
City
Bogotá
Country
Colombia
Facility Name
Novartis Investigative Site
City
Cali
Country
Colombia
Facility Name
Novartis Investigative Site
City
Amman
ZIP/Postal Code
11942
Country
Jordan
Facility Name
Novartis Investigative Site
City
Irbid
ZIP/Postal Code
22110
Country
Jordan
Facility Name
Novartis Investigative Site
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Penang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Novartis Investigative Site
City
México
State/Province
Distrito Federal
ZIP/Postal Code
10700
Country
Mexico
Facility Name
Novartis Investigative Site
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Novartis Investigative Site
City
San Nicolas De Los Garza
State/Province
Nuevo León
ZIP/Postal Code
66480
Country
Mexico
Facility Name
Novartis Investigative Site
City
San Luis Potosí
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Novartis Investigative Site
City
Panama City
State/Province
Panamá
Country
Panama
Facility Name
Novartis Investigative Site
City
La Perla
State/Province
Callao
ZIP/Postal Code
04
Country
Peru
Facility Name
Novartis Investigative Site
City
Jesus Maria
State/Province
Lima
ZIP/Postal Code
11
Country
Peru
Facility Name
Novartis Investigative Site
City
San Isidro
State/Province
Lima
ZIP/Postal Code
27
Country
Peru

12. IPD Sharing Statement

Citations:
PubMed Identifier
26170105
Citation
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. Erratum In: Adv Ther. 2015 Jul;32(7):636.
Results Reference
derived

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

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