check_circleStudy Completed

Multiple Sclerosis, Relapsing-Remitting

Bayer Identifier:

91293

ClinicalTrials.gov Identifier:

NCT00206648

EudraCT Number:

Not Available

EU CT Number:

Not Available
An efficacy and safety comparison study of two marketed drugs in patients with relapsing-remitting MS

Trial purpose

The purpose of this study is to determine the difference in preventing a relapse between Betaseron and Avonex. Patients with RRMS currently treated with Avonex will be randomized into 2 equal-size arms; one arm will continue on the standard dose of Avonex; one arm will be converted to Betaseron standard dose.

Key Participants Requirements

Sex

Both

Age

18 - 60 Years
  • - RRMS patients that are receiving treatment with Avonex 30 µg once weekly
  • - Primary Progressive or Secondary Progressive MS

Trial summary

Enrollment Goal
271
Trial Dates
March 2003 - October 2005
Phase
Phase 4
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Axiom Clinical ResearchTampa, 33609, United States
Completed
Mercy Health CenterOklahoma City, 73120, United States
Completed
East Bay Region Associates in NeurologyBerkeley, 94705, United States
Completed
Northwest NeuroSpecialists, PLLCTucson, 85741, United States
Completed
Minneapolis Clinic of Neurology, Ltd.Golden Valley, 55422, United States
Completed
Medical University of South CarolinaCharleston, 29425, United States
Completed
Medford Neurological & Spine ClinicMedford, 97504, United States
Completed
Neurology Foundation, Inc.Providence, 02905, United States
Completed
Shepherd CenterAtlanta, 30309-1465, United States
Completed
Mid-America Neuroscience InstituteKansas City, 64108, United States
Completed
SUNY at Stony BrookBuffalo, 14215, United States
Completed
Neurology Medical Group of Diablo ValleyWalnut Creek, 94598, United States
Completed
University of California Davis Medical CenterSacramento, 95817, United States
Completed
University of Kansas Medical CenterKansas City, 66160, United States
Completed
Faculty Physicians and Surgeons of LLU School of MedicineLoma Linda, 92354, United States
Completed
Fort Wayne Neurological CenterFort Wayne, 46805, United States
Completed
Asheville Neurology Specialists, PAAsheville, 28801, United States
Completed
Neurology Center of Fairfax, Ltd.Fairfax, 22031, United States
Completed
Roanoke NeurologicalRoanoke, 24014, United States
Completed
Louisiana State University Medical CenterShreveport, 71130, United States
Completed
Office of Dr. Harmeet Sachdev, MDSan Jose, 95124, United States
Completed
Neurological Associates of AlbanyAlbany, 12208, United States
Completed
Multiple Sclerosis Center of BrevardMelbourne, 32940, United States
Completed
Tampa General HospitalTampa, 33606, United States
Completed
Neurology & Neurosurgery Associates of Tacoma, Inc.Tacoma, 98405, United States
Completed
Wayne State UniversityDetroit, 48201, United States
Completed
University of California, Los AngelesLos Angeles, 90095-1721, United States
Completed
University of MarylandBaltimore, 21201, United States
Completed
Mercy Ruan Neurology ClinicDes Moines, 50314, United States
Completed
Winthrop-University HospitalMineola, 11501, United States
Completed
Medical College of GAAugusta, 30912, United States
Completed
Indiana UniversityIndianapolis, 46202, United States
Completed
Neurology Specialists, Inc.Dayton, 45409, United States
Completed
University of MinnesotaMinneapolis, 55455, United States
Completed
Neurological Research Institute of the East BayWalnut Creek, 94596, United States
Completed
Springfield ClinicSpringfield, 62703, United States
Completed
Virginia Mason Medical CenterSeattle, 98101, United States
Completed
University of MiamiMiami, 33136, United States
Completed
Gottschalk Medical PlazaIrvine, 92697, United States
Completed
Wake Forest University Medical CenterWinston-Salem, 27157, United States
Completed
Hospital of the University of PennsylvaniaPhiladelphia, 19104, United States
Completed
Baylor CollegeHouston, 77030, United States
Completed
Ottawa Hospital-General CampusOttawa, K1H 8L6, Canada
Completed
University of New MexicoAlbuquerque, 87131-5281, United States
Completed
Neurology Associates, PAWilmington, 19806, United States
Completed
University of Nevada-RenoReno, 89509, United States
Completed
Neurological Institute of SavannahSavannah, 31405, United States
Completed
Washington University School of MedicineSt. Louis, 63110, United States
Completed
NYU Hospital for Joint DiseasesNew York, 10003, United States
Completed
Columbus Research InstituteColumbus, 31909, United States
Completed
Mayo Clinic - RochesterRochester, 55905, United States
Completed
Ottawa Headache Centre WestNepean, K2G 6E2, Canada
Completed
South Suburban Neurology, Ltd.Flossmoor, 60422, United States

Primary Outcome

  • Time to onset of first relapse
    date_rangeTime Frame:
    Time to onset of first relapse
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Number of patients relapse free at week 104
    date_rangeTime Frame:
    At week 104
    enhanced_encryption
    Safety Issue:
    no

Trial design

A Randomized, Rater-blinded, Multicenter, Parallel-group Study Comparing the Efficacy and Safety of Betaseron 250 µg Subcutaneously Every Other Day with Avonex 30 µg Intramuscularly Once per Week in Relapsing-remitting Multiple Sclerosis Patients Previously Treated with Avonex
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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