Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy

Relapsing Remitting Multiple Sclerosis Clinical Trial

— EARLiMS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498887
• Other study ID #: CFTY720DES03
• Secondary ID: 2011-003484-30
• Status: Completed
• Phase: Phase 4
• Start date: December 24, 2011
• Est. completion date: December 26, 2015

Study information

• Verified date: August 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: December 26, 2015
• Est. primary completion date: December 26, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Fingolimod (FTY720)
Hard gelatin capsules containing 0.5 mg of fingolimod.

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Adelaide	South Australia
Australia	Novartis Investigative Site	Auchenflower	Queensland
Australia	Novartis Investigative Site	Bedford Park
Australia	Novartis Investigative Site	Box Hill	Victoria
Australia	Novartis Investigative Site	Brisbane Queensland
Australia	Novartis Investigative Site	East Gosford	New South Wales
Australia	Novartis Investigative Site	Fitzroy	Victoria
Australia	Novartis Investigative Site	Geelong VIC
Australia	Novartis Investigative Site	Kanwal	New South Wales
Australia	Novartis Investigative Site	Liverpool	New South Wales
Australia	Novartis Investigative Site	Melbourne	Victoria
Australia	Novartis Investigative Site	Nedlands	Western Australia
Australia	Novartis Investigative Site	New Lambton Heights	New South Wales
Australia	Novartis Investigative Site	Parkville	Victoria
Australia	Novartis Investigative Site	Sydney	New South Wales
Spain	Novartis Investigative Site	Albacete	Castilla La Mancha
Spain	Novartis Investigative Site	Badalona	Catalunya
Spain	Novartis Investigative Site	Barakaldo	Pais Vasco
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Bilbao	Pais Vasco
Spain	Novartis Investigative Site	Córdoba	Andalucia
Spain	Novartis Investigative Site	Ferrol	A Coruna
Spain	Novartis Investigative Site	Granada	Andalucia
Spain	Novartis Investigative Site	La Coruna	Galicia
Spain	Novartis Investigative Site	Las Palmas de Gran Canaria	Las Palmas De G.C
Spain	Novartis Investigative Site	Las Palmas de Gran Canaria
Spain	Novartis Investigative Site	Leon	Castilla Y León
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Oviedo	Asturias
Spain	Novartis Investigative Site	Palma De Mallorca	Islas Baleares
Spain	Novartis Investigative Site	Pamplona	Navarra
Spain	Novartis Investigative Site	Santa Cruz de Tenerife
Spain	Novartis Investigative Site	Santander	Cantabria
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Tarragona	Cataluña
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valladolid	Castilla Y Leon

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual Relapse Rate (ARR)	ARR = 365 days * number of relapses / total days taking the study medication.	12 months
Secondary	Time to First Relapse	Time to first relapse was defined as the time from the first day of treatment to the first day of a new neurological symptom or worsening of an existing one.	first day of treatment to the first day of a new neurological symptom or worsening of an existing one, up to 12 months
Secondary	Change From Baseline in Expanded Disability Status Scale (EDSS) Score	The EDSS is an ordinal clinical rating scale ranging from a total score of 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. A negative change from baseline indicates improvement.	baseline, 12 months
Secondary	Change From Baseline in Cerebral Volume	Cerebral volume was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.	baseline, 12 months
Secondary	Percentage of Participants With Mild, Moderate or Severe Relapse	The investigator classified a relapse as moderate-severe if oral or intravenous (IV) treatment (according to the local clinical practice) with steroids and/or hospitalization was needed. If neither oral nor IV treatment with steroids nor hospitalization was needed, the relapse was considered as mild.	12 months
Secondary	Percentage of Relapse-free Participants	Relapse-free participants were defined as participants who experienced no new neurological symptom or worsening of an existing one (relapses) during the 12-month treatment period with 0.5 mg fingolimod.	12 months
Secondary	Mean Number of T2 Active Lesions	The mean number of new or enlarged T2 active lesions was assessed by MRI.	12 months