Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00289978

Purpose

This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)

Condition	Intervention	Phase
Relapsing-remitting Multiple Sclerosis	Drug: Fingolimod 1.25 mg Drug: Fingolimod 0.5 mg Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Fingolimod FTY 720

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Estimated Annualized Aggregate Relapse Rate (ARR) [ Time Frame: Baseline to end of study (Month 24) ] [ Designated as safety issue: No ]
The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group calculated as the total number of confirmed relapses divided by the total number of days on study, multiplied by 365.25.

Secondary Outcome Measures:

Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline to end of study (Month 24) ] [ Designated as safety issue: No ]
EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the following: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression required onset EDSS, 3-month confirming EDSS, and all EDSS in between to meet the disability progression criteria. Percent of free of disability progression was calculated using the Kaplan Meier method.
Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline [ Time Frame: Baseline to end of study (Month 24) ] [ Designated as safety issue: No ]
The number of new or newly enlarged T2 lesions at Month 24 in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.

Enrollment:	1272
Study Start Date:	January 2006
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fingolimod 1.25 mg	Drug: Fingolimod 1.25 mg Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Experimental: Fingolimod 0.5 mg	Drug: Fingolimod 0.5 mg Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Placebo Comparator: Placebo	Drug: Placebo Patients self-administered a fingolimod placebo capsule orally once daily.

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 multiple sclerosis
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

Other protocol-defined inclusion/exclusion criteria applied to this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289978

Show 115 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kappos L, Radue EW, O'Connor P, Polman C, Hohlfeld R, Calabresi P, Selmaj K, Agoropoulou C, Leyk M, Zhang-Auberson L, Burtin P; FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010 Feb 4;362(5):387-401. Epub 2010 Jan 20.

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00289978 History of Changes
Other Study ID Numbers:	CFTY720D2301
Study First Received:	February 9, 2006
Results First Received:	January 4, 2011
Last Updated:	February 22, 2011
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Novartis:

Multiple Sclerosis
FTY720
Fingolimod

Additional relevant MeSH terms:

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

Immune System Diseases
Pathologic Processes
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012