Clinical trial NCT01497262: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Relapsing-Remitting
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-12-22
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 28 weeks
Secondary outcomes:
measure: Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.
timeFrame: 4 months
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Guaymallen
country: Argentina
facility: Novartis Investigative Site
state: Mendoza
city: San Miguel de Tucuman
country: Argentina
facility: Novartis Investigative Site
state: Tucumán
city: San Miguel de Tucumán
country: Argentina
facility: Novartis Investigative Site
state: Tucumán
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Salta
country: Argentina
facility: Novartis Investigative Site
city: Salta
country: Argentina
facility: Novartis Investigative Site
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
state: Atlantico
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
state: Cundinamarca
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
city: Cali
country: Colombia
facility: Novartis Investigative Site
city: Amman
country: Jordan
facility: Novartis Investigative Site
city: Irbid
country: Jordan
facility: Novartis Investigative Site
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Penang
country: Malaysia
facility: Novartis Investigative Site
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: México
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Novartis Investigative Site
state: Nuevo León
city: San Nicolas De Los Garza
country: Mexico
facility: Novartis Investigative Site
state: Nuevo León
city: San Luis Potosí
country: Mexico
facility: Novartis Investigative Site
city: Panama City
country: Panama
facility: Novartis Investigative Site
state: Panamá
city: La Perla
country: Peru
facility: Novartis Investigative Site
state: Callao
city: Jesus Maria
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Isidro
country: Peru
facility: Novartis Investigative Site
state: Lima
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
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.