Efficacy and Safety of Fingolimod in Patients With Relapsing-Remitting Multiple Sclerosis With Optional Extension Phase - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00340834

Purpose

This study will assess safety, tolerability and efficacy of two doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Fingolimod Drug: Interferon beta-1a	Phase III

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferons Interferon beta Interferon-beta FTY 720 Interferon beta 1a Fingolimod

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-Month Study Comparing the Efficacy and Safety of Two Doses of Fingolimod Versus Interferon β-1a in Patients With Relapsing-Remitting Multiple Sclerosis With Optional Extension Phase

Further study details as provided by Novartis:

Primary Outcome Measures:

Annualized relapse rate in patients with RRMS treated for up to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of relapse-free patients treated for up to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Safety and tolerability of fingolimod in patients treated for up to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Burden of disease and inflammatory activist as measured by MRI lesion parameters in patients treated for up to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	1292
Study Start Date:	May 2006
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Fingolimod FTY720 1.25 mg/day
2: Experimental	Drug: Fingolimod FTY720 0.5 mg/day
3: Active Comparator	Drug: Interferon beta-1a

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients between ages 18-55 with a diagnosis of MS
Patients with a relapsing-remitting disease course
Patients with EDSS score of 0-5.5

Exclusion Criteria:

Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc
Pregnant or nursing women
Patients who cannot tolerate treatment with an interferon

Other protocol-define inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00340834

Show 141 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharma AG Basel: +41 61 324 1111

Novartis Pharmacuticals

More Information

Fingolimod clinical trials information website This link exits the ClinicalTrials.gov site

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CFTY720D2302
Study First Received:	June 19, 2006
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00340834
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Fingolimod
FTY720
Interferon

RRMS
Multiple Sclerosis
Efficacy

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Fingolimod
Interferons
Interferon beta 1a

Interferon-beta
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Anti-Infective Agents
Pathologic Processes
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009