Clinical trial NCT01498887: Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy
Official title: A Multi-centre, Open-label, Non-randomised, Parallel Group Clinical Trial to Assess the Efficacy of Fingolimod in Naive Patients Versus Fingolimod in Patients Previously Treated With Interferons or Glatiramer Acetate, Based on the Presence of Relapses in Patients With Relapsing-remitting Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis
Relapsing Remitting Multiple Sclerosis
Fingolimod
Early multiple sclerosis
Naive patients
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assessed the efficacy of fingolimod in patients with short duration relapsing-remitting multiple sclerosis who had not been previously treated with disease-modifying therapies (DMTs), versus patients with the same disease duration who had previously received first-line DMTs.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with multiple sclerosis, according to the 2010 revised McDonald criteria, with a relapsing-remitting course, and with at least 9 T2 lesions consistent with the disease, with disease duration greater than or equal to one year and less than or equal to five years.
* Patients who have had at least two relapses in the past two years and an Expanded Disability Status Scale score between 0 and 3.5, inclusive.

Patients

* Treatment naïve: patients who have never been treated with a Disease Modifying Therapy or
* Previously treated with a first-line Disease Modifying Therapy

Exclusion Criteria:

* Patients who have received treatment with:

Fingolimod at any time (e.g. participation in a fingolimod clinical trial), Immunosuppressant drugs such as azathioprine or methotrexate at any time; Immunoglobulins in the past 6 months. Monoclonal antibodies including natalizumab, Cladribine, cyclophosphamide or mitoxantrone, at any time.

- Other protocol defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Annual Relapse Rate (ARR)
timeFrame: 12 months
Secondary outcomes:
measure: Time to First Relapse
timeFrame: first day of treatment to the first day of a new neurological symptom or worsening of an existing one, up to 12 months
measure: Change From Baseline in Expanded Disability Status Scale (EDSS) Score
timeFrame: baseline, 12 months
measure: Change From Baseline in Cerebral Volume
timeFrame: baseline, 12 months
measure: Percentage of Participants With Mild, Moderate or Severe Relapse
timeFrame: 12 months
measure: Percentage of Relapse-free Participants
timeFrame: 12 months
measure: Mean Number of T2 Active Lesions
timeFrame: 12 months
Other outcomes:
Locations:
city: East Gosford
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Kanwal
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Liverpool
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: New Lambton Heights
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Sydney
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Auchenflower
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Box Hill
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Fitzroy
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Nedlands
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Bedford Park
country: Australia
facility: Novartis Investigative Site
city: Brisbane Queensland
country: Australia
facility: Novartis Investigative Site
city: Geelong VIC
country: Australia
facility: Novartis Investigative Site
city: Ferrol
country: Spain
facility: Novartis Investigative Site
state: A Coruna
city: Córdoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Granada
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Oviedo
country: Spain
facility: Novartis Investigative Site
state: Asturias
city: Santander
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: Albacete
country: Spain
facility: Novartis Investigative Site
state: Castilla La Mancha
city: Valladolid
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Leon
country: Spain
facility: Novartis Investigative Site
state: Castilla Y León
city: Badalona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Tarragona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: La Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Palma De Mallorca
country: Spain
facility: Novartis Investigative Site
state: Islas Baleares
city: Las Palmas de Gran Canaria
country: Spain
facility: Novartis Investigative Site
state: Las Palmas De G.C
city: Pamplona
country: Spain
facility: Novartis Investigative Site
state: Navarra
city: Barakaldo
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Bilbao
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Las Palmas de Gran Canaria
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Santa Cruz de Tenerife
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: