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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 (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase


Phase 3
18 Years
55 Years
Not Enrolling
Both
Multiple Sclerosis

Thank you

Trial Information

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 (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase


Inclusion Criteria:



- Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
(MS)

- Patients with a relapsing-remitting disease course

- Patients with Expanded Disability Status Scale (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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study

Outcome Description:

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 calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.

Outcome Time Frame:

Baseline to Month 12

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmacuticals

Authority:

United States: Food and Drug Administration

Study ID:

CFTY720D2302

NCT ID:

NCT00340834

Start Date:

May 2006

Completion Date:

July 2011

Related Keywords:

  • Multiple Sclerosis
  • FTY720
  • Interferon
  • RRMS
  • Multiple Sclerosis
  • Efficacy
  • Multiple Sclerosis
  • Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting

Name

Location

Baylor College of MedicineHouston, Texas  77030
University of Florida Health Science CenterGainesville, Florida  32610-0296
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Cleveland ClinicCleveland, Ohio  44195
Barrow Neurological InstitutePhoenix, Arizona  85013
Neurological AssociatesSunrise, Florida  33351
North Central Neurology Associates, PC, 1809 Kress StreetCullman, Alabama  35058
The Neurology Center, 3907 Waring Road, Suite 3Oceanside, California  92056
Associated Neurologists, PC, 69 Sand Pit Road, Suite 300Danbury, Connecticut  06810
Associated Neurologists of Southern CT, PC, 75 Kings Highway CutoffFairfield, Connecticut  06824
Yale University Multiple Sclerosis CenterNew Haven, Connecticut  06510
Neurology Associates, PA, 301 N. Maitland Avenue, Suite A1Maitland, Florida  32751
University of Miami, Department of NeurologyMiami, Florida  33136
Roskamp Institute, 2040 Whitfield Ave.Sarasota, Florida  34243
AMO CorporationTallahassee, Florida  32308
Axiom Clinical Research of Florida, 2919 Swann Avenue, Suite 401Tampa, Florida  33609
University of South Florida, Department of NeurologyTampa, Florida  33612
The MS Center of Vero BeachVero Beach, Florida  32960
Mid America Neuroscience Institute, 8550 Marshall Drive, Suite 100Lenexa, Kansas  66214
University Physician Group, #1 Barnes-Jewish Hospital Plaza, Suite 16304St. Louis, Missouri  63110
Neuroscience and Spine CenterCharlotte, North Carolina  28207
Raleigh Neurology Associates, 1540 Sunday DriveRaleigh, North Carolina  27607
Neurology & Neuroscience Associates, IncAkron, Ohio  44302
Northern Ohio Neuroscience, LLCBellevue, Ohio  44811
Oregon NeurologyTualatin, Oregon  97062
University of Pittsburgh, Department of NeurologyPittsburgh, Pennsylvania  15213
Absher Neurology, 274-A Commonwealth DriveGreenville, South Carolina  29615
Mountain Empire Neurological Associates, PC, 3183 West State Street, Suite 1201Bristol, Tennessee  37620
Advanced Neurosciences InstituteFranklin, Tennessee  37064
Private Practice, 3815 23rd StreetLubbock, Texas  79410
Integra Clinical Research, 4242 Medical Drive, Suite 6100San Antonio, Texas  78229
Swedish Neuroscience InstituteSeattle, Washington  98122
Rockwood Clinic, P.S.Spokane, Washington  99202
West Virginia University Health AssociatesMorgantown, West Virginia  26506
Center for Neurological Disorders - Aurora St. Luke's Med CenterMilwaukee, Wisconsin  53215