Know Cancer

or
forgot password

An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab


Phase 3
N/A
N/A
Open (Enrolling)
Both
Multiple Sclerosis, Relapsing-Remitting

Thank you

Trial Information

An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab


Alemtuzumab treatment will either be on a fixed schedule of two treatment cycles a year
apart for patients who received Rebif® in one of the prior Genzyme-sponsored studies of
alemtuzumab or on an as needed schedule (e.g. due to documented evidence of resumed MS
activity) for patients who have already completed a fixed schedule of treatment with
alemtuzumab in one of the prior Genzyme-sponsored studies. There is no comparison treatment
in this study. All patients will be required to return to their study site every 3 months
for neurologic and other assessments. In addition, safety-related laboratory tests and
surveys will be performed at least monthly. Participation in the extension study will last
48 months from enrollment, but some patients may need additional safety follow-up via a
separate mechanism beyond the 48 months.


Inclusion Criteria:



- 1.Received alemtuzumab in CAMMS323 or CAMMS324, completed the 2-year study period,
and have not subsequently received disease modifying treatments (other than
glatiramer acetate or interferon beta); or

- 2.Received Rebif® in CAMMS323 or CAMMS324, completed the 2-year study period, and
have not subsequently received alternative disease modifying treatments (other than
glatiramer acetate or another interferon beta); or

- 3.Participated in CAMMS223.

- NOTE: Criteria 1 and 2 above mean that patients who enrolled in CAMMS323 or CAMMS324
but did not complete the 2-year study period or went on to receive non-study drug
DMTs after randomization are not eligible for inclusion in the Extension Study.
Patients who enrolled in CAMMS324 after participation in CAMMS223 must meet criteria
1 or 2 to be eligible for inclusion in the Extension Study.

Exclusion Criteria:

- Any alemtuzumab patient from CAMMS223, CAMMS323, or CAMMS324 who has received
alemtuzumab off-label (ie, outside of one of the prior Genzyme-sponsored studies), or
is participating in any other investigational study, unless approved by Genzyme. In
addition, these patients must be screened for disqualifying safety concerns before
receiving alemtuzumab retreatment.

- Any Rebif® patient from CAMMS223, CAMMS323, or CAMMS324 who meets any of the
following criteria. In addition, these patients must be screened for disqualifying
safety concerns before receiving alemtuzumab treatment. a)Does not wish to receive
alemtuzumab; b) Ongoing participation in any other investigational study, unless
approved by Genzyme; c)Has received alemtuzumab off-label (ie, outside of one of the
prior Genzyme-sponsored studies); d)Known bleeding disorder or therapeutic
anticoagulation; e)Diagnosis of idiopathic thrombocytopenia purpura or other
autoimmune hematologic abnormality; f)History of malignancy, except basal cell skin
carcinoma; g)Intolerance of pulsed corticosteroids, especially a history of steroid
psychosis h)Significant Autoimmune disorder (other than MS); i)Major psychiatric
disorder or epileptic seizures not adequately controlled by treatment; j)Active
infection or high risk for infection k)Unwilling to use a reliable and acceptable
contraceptive method during and for at least 6 months following each alemtuzumab
treatment cycle (fertile patients only).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time to Sustained Accumulation of Disability (SAD)

Outcome Time Frame:

Prior study baseline through Extension Month 48

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme Coorporation

Authority:

United States: Food and Drug Administration

Study ID:

CAMMS03409

NCT ID:

NCT00930553

Start Date:

August 2009

Completion Date:

February 2016

Related Keywords:

  • Multiple Sclerosis, Relapsing-Remitting
  • Multiple Sclerosis
  • Multiple Sclerosis
  • Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
Stanford University Medical CenterStanford, California  94305-5408
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
University of Chicago Medical CenterChicago, Illinois  60637
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
The University Of North Carolina At Chapel HillChapel Hill, North Carolina  27599-7235
Neuro-Therapeutics, Inc.Pasadena, California  91105
Neurological AssociatesSunrise, Florida  33351
Fort Wayne Neurological CenterFort Wayne, Indiana  46805
Associates in Neurology, P.S.C.Lexington, Kentucky  40503
Central Texas Neurology ConsultantsAustin, Texas  78681
Neurology Center of San AntonioSan Antonio, Texas  78212
Lehigh Valley Hospital Neurosciences and Pain ResearchAllentown, Pennsylvania  18103
UMass Memorial Medical CenterWorcester, Massachusetts  01655
Advanced Neurosciences InstituteFranklin, Tennessee  37064
University of Michigan Medical SchoolAnn Arbor, Michigan  48106
North Central Neurology Associates, P.C.Cullman, Alabama  
Northwest NeuroSpecialists, PLLCTucson, Arizona  
Axiom Clinical Research of FloridaTampa, Florida  
MidAmerica Neuroscience InstituteLenexa, Kansas  
Oak Clinic for Multiple SclerosisUniontown, Ohio  
Baylor College of Medicine, Maxine Mesinger MS ClinicHouston, Texas  
Hope Research InstitutePhoenix, Arizona  
University of Florida Neuroscience InstituteJacksonville, Florida  
Neurology Associates, P.A.Maitland, Florida  
Negroski, Stein, Sutherland and Hanes NeurologySarasota, Florida  
Consultants in Neurology, LtdNorthbrook, Illinois  
Iowa Health PhysiciansDes Moines, Iowa  
MS Center at Holy Name HospitalTeaneck, New Jersey  
Integra Clinical ResearchSan Antonio, Texas  
MS Center of Greater WashingtonVienna, Virginia  
East Bay Physicians Medical Group/ Sutter East Bay Medical FoundationBerkeley, California  
Emory University Department of NeurologyAtlanta, Georgia  
Northern Michigan NeurologyTraverse City, Michigan  
Wake Forest University Health Science Department of NeurologyWinston-Salem, North Carolina  
Neurology Clinic PCCordova, Tennessee  
St. Joseph's Hospital and Medical Center Barrow Neurology Clinics - Barrow Neurological InstitutePhoenix, Arizona  
Mayo Clinic Arizona (Scottsdale)Scottsdale, Arizona  
Neurology Center North Orange CountyLa Habra, California  
University of Southern California Keck School of Medicine/University of Southern California LAC & USC Medical CenterLos Angeles, California  
University of Colorado Health Science Center - AuroraAurora, Colorado  
Advanced Neurology of ColoradoFt. Collins, Colorado  
Yale MS Research CenterNew Haven, Connecticut  
The George Washington University Medical Faculty AssociatesWashington, District of Columbia  
University of South Florida College of MedicineTampa, Florida  
Shepherd Center Multiple Sclerosis InstituteAtlanta, Georgia  
Indiana University Multiple Sclerosis CenterIndianapolis, Indiana  
Ruan Neurology Clinic and Clinical Research Center, Mercy Medical CenterDes Moines, Iowa  
University of Kansas Medical Center, Department of NeurologyKansas City, Kansas  
Kentucky Neuroscience ResearchLouisville, Kentucky  
University of Maryland, Maryland Center for MSBaltimore, Maryland  
The MS Center at St. Elizabeth'sBoston, Massachusetts  
Michigan Neurology AssociationClinton Twp, Michigan  
Wayne State University, The School of Medicine, Department of NeurologyDetroit, Michigan  
Spectrum Health Medical Group, Neurology/Michigan Medical P.C., West Michigan MS ClinicGrand Rapids, Michigan  
Saint Luke's Brain & Stroke InstituteKansas City, Missouri  
Renown Institute for NeurosciencesReno, Nevada  
University of New Mexico, Dept. of NeurologyAlbuquerque, New Mexico  
Empire Neurology P.C.Latham, New York  
Winthrop University Hospital Multiple Sclerosis Treatment CenterMineola, New York  
MS Care Center at NYUMC and HJDNew York, New York  
The Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount SinaiNew York, New York  
South Shore Neurologic Associates, P.C.Patchogue, New York  
Rochester Multiple Sclerosis CenterRochester, New York  
SUNY Upstate Medical University, Department of NeurologySyracuse, New York  
OMRF Multiple Sclerosis Center of ExcellenceOklahoma City, Oklahoma  
Rhode Island Hospital MS Center - The Neurology Foundation, IncProvidence, Rhode Island  
Hope NeurologyKnoxville, Tennessee  
Swedish Medical MS CenterSeattle, Washington