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

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

Purpose

This study will assess safety, tolerability, and efficacy of 2 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 1.25 mg Drug: Fingolimod 0.5 mg Drug: Interferon β-1a 30 µg	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod Administered Orally Once Daily Versus Interferon ß-1a Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Fingolimod FTY 720 Interferons

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Annualized Aggregate Relapse Rate (ARR) [ Time Frame: Baseline to end of study (Month 12) ] [ 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:

Number of New or Newly Enlarged T2 Lesions at Month 12 in Comparison With Baseline [ Time Frame: Baseline to end of study (Month 12) ] [ Designated as safety issue: No ]
The number of new or newly enlarged T2 lesions at Month 12 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.
Percentage of Participants Free of Disability Progression at Month 12 Assessed With the Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline to end of study (Month 12) ] [ Designated as safety issue: No ]
The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: 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. Percent of patients free of disability progression was calculated using the Kaplan Meier method.

Enrollment:	1292
Study Start Date:	May 2006
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (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. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
Experimental: Fingolimod 0.5 mg	Drug: Fingolimod 0.5 mg Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
Active Comparator: Interferon β-1a 30 µg	Drug: Interferon β-1a 30 µg Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they 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 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-defined inclusion/exclusion criteria applied to the study.

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

No publications provided by Novartis

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

Twiss J, Doward LC, McKenna SP, Eckert B. Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS). Health Qual Life Outcomes. 2010 Oct 11;8:117.

Cohen JA, Barkhof F, Comi G, Hartung HP, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, Tiel-Wilck K, de Vera A, Jin J, Stites T, Wu S, Aradhye S, Kappos L; TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010 Feb 4;362(5):402-15. Epub 2010 Jan 20.

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00340834 History of Changes
Other Study ID Numbers:	CFTY720D2302
Study First Received:	June 19, 2006
Results First Received:	January 4, 2011
Last Updated:	April 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

FTY720
Interferon
RRMS
Multiple Sclerosis
Efficacy

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

Interferons
Fingolimod
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012