Trial record 3 of 5 for:    alemtuzumab | Interventional Studies | multiple sclerosis | Phase 3

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One (CARE-MS I)

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00530348
First received: September 13, 2007
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to establish the efficacy and safety of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with Rebif® (interferon beta-1a). The study will enroll patients who have not previously received treatment to suppress MS, except steroids. Patients will have monthly laboratory tests and comprehensive testing every 3 months.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Biological: alemtuzumab
Biological: interferon beta-1a (Rebif®)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Primary Outcome Measures:
  • Time to Sustained Accumulation of Disability (SAD) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Relapse Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients who are relapse free at Year 2 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change from baseline in Expanded Disability Status Scale (EDSS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Acquisition of disability as measured by change from baseline in Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Percent change from baseline in magnetic resonance imaging (MRI)-T2 hyperintense lesion volume at Year 2 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 581
Study Start Date: September 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alemtuzumab 12 mg Biological: alemtuzumab
12 mg per day administered through IV, once a day for 5 consecutive days at Month 0 and 12 mg per day administered through IV, once a day for 3 consecutive days at Month 12.
Active Comparator: interferon beta-1a (Rebif ®) 44mcg Biological: interferon beta-1a (Rebif®)
44 mcg administered 3-times weekly by SC injections for 2 years

Detailed Description:

Every patient will receive active treatment; there is no placebo. Patients who qualify will be randomly assigned to treatment with either alemtuzumab or Rebif® at a 2:1 ratio (ie, 2 given alemtuzumab for every 1 given Rebif®). Alemtuzumab will be administered in two annual cycles, once at the beginning of the study and again 1 year later. Rebif® will be self-injected 3 times per week for 2 years. All patients will be required to return to their study site every 3 months for neurologic assessment. In addition, safety-related laboratory tests will be performed at least monthly. Participation in this study will end 2 years after the start of treatment for each patient. Additionally, patients who receive alemtuzumab may be followed in CAMMS03409 (NCT 00930553) an extension study for safety and efficacy assessments. Patients who receive Rebif® and complete 2 years on study may be eligible to receive alemtuzumab on the extension study.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of MS and cranial MRI scan demonstrating white matter lesions attributable to MS within 5 years
  • Onset of MS symptoms within 5 years
  • EDSS score 0.0 to 3.0
  • ≥2 MS attacks within 24 months, with ≥1 attack within 12 months

Exclusion Criteria:

  • Received prior therapy for MS other than corticosteroids
  • Exposure to immunosuppressive or immunomodulatory agents other than systemic corticosteroid treatment
  • Received treatment with a monoclonal antibody for any reason
  • Previous treatment with any investigational drug (i.e. medication that is not approved at any dose for any indication)
  • Has any progressive form of MS
  • Any disability acquired from trauma or another illness that could interfere with evaluation of disability due to MS
  • Major systemic disease that cannot be treated or adequately controlled by therapy
  • Active infection or high risk for infection
  • Autoimmune disorder (other than MS)
  • Impaired hepatic or renal function
  • History of malignancy, except basal skin cell carcinoma
  • Medical, psychiatric, cognitive, or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
  • Known bleeding disorder
  • Of childbearing potential with a positive serum pregnancy test, pregnant or lactating
  • Current participation in another clinical study
  • Previous hypersensitivity reaction to any immunoglobulin product
  • Known allergy or intolerance to interferon beta, human albumin, or mannitol
  • Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
  • Inability to self-administer subcutaneous (SC) injections or receive SC injections from caregiver
  • Inability to undergo MRI with gadolinium administration
  • Unwilling to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530348

  Hide Study Locations
Locations
United States, Alabama
North Central Neurology Associates, P.C.
Cullman, Alabama, United States
United States, Arizona
Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, United States
United States, Colorado
Advanced Neurosciences Research LLC
Fort Collins, Colorado, United States
United States, Florida
Neurological Associates
Pompano Beach, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
United States, Idaho
Eastern Idaho Neurological Associates
Idaho Falls, Idaho, United States
United States, Illinois
Consultants in Neurology, Ltd.
Northbrook, Illinois, United States
United States, Indiana
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States
MidAmerica Neuroscience Institute
Lenexa, Kansas, United States
United States, Kentucky
Associates in Neurology, PSC
Lexington, Kentucky, United States
University of Louisville, Kentucky Neuroscience Research
Louisville, Kentucky, United States
United States, Louisiana
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States
United States, Massachusetts
UMass Memorial Health Care
Worcester, Massachusetts, United States
United States, Michigan
University of Michigan Department of Neurology
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
United States, New York
Empire Neurology PC
Latham, New York, United States
NYU Hospital of Joint Diseases
New York, New York, United States
Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C.
Patchogue, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
United States, North Carolina
Carolinas Medical Center (CMC)/Neurosciences & Spine Institute (NSSI)
Charlotte, North Carolina, United States
United States, Ohio
The Ohio State University Medical Center, Multiple Sclerosis Center
Columbus, Ohio, United States
Oak Clinic for Multiple Sclerosis
Uniontown, Ohio, United States
United States, Oklahoma
MS Center of Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Lehigh Valley Hospital, Neuroscience and Pain Research
Allentown, Pennsylvania, United States
United States, Tennessee
Advanced Neurosciences Institute
Franklin, Tennessee, United States
Sibyl Wray, MD, Neurology, PC
Knoxville, Tennessee, United States
United States, Texas
Baylor College of Medicine, Maxine Mesinger MS Clinic
Houston, Texas, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
Integra Clinical Research, L.L.C.
San Antonio, Texas, United States
Neurology Center of San Antonio
San Antonio, Texas, United States
Argentina
DIABAID
Capital Federal, Argentina
Australia, Queensland
The Wesley Research Institute
Auchenflower, Queensland, Australia, 4066
Griffith University and Gold Coast Hospital
Southport, Queensland, Australia
Australia, South Australia
Flinders Medical Center
Bedford Park, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Australia, Tasmania
Royal Hobart Hospital, Tasmania
Hobart, Tasmania, Australia, 7000
Australia, Victoria
St Vincents Hospital
Fitzroy, Victoria, Australia, 3065
Austin Health
Heidelberg, Victoria, Australia, 3084
Royal Melbourne Hospital, Department of Neurology, Ward 4 East
Parkville, Victoria, Australia, 3050
Australia
Concord Repatriation General Hospital
Concord, Australia
Southern Neurology
Kogarah, Australia
Brazil
Hospital Sao Lucas da PUC-RS
Porto Alegre, RS, Brazil
Hospital das Clinicas da Faculdade de Medicina da USP
Sao Paulo, SP, Brazil
Canada, Alberta
Foothills Medical Center, MS Clinic, SSB
Calgary, Alberta, Canada
Canada, British Columbia
UBC Hospital
Vancouver, British Columbia, Canada
Canada, Ontario
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada
Canada, Quebec
Clinique Nuero-outaouais
Gatineau, Quebec, Canada
Clinique Nuero rive-sud, Recherche sepmus inc.
Greenfield park, Quebec, Canada
Croatia
Clinical Hospital Centre "Rijeka"
Rijeka, Croatia
General Hospital Varazdin
Varazdin, Croatia
Clinic of Neurology Clinical Hospital "Sestre milosrdnice"
Zagreb, Croatia
General Hospital Sveti Duh
Zagreb, Croatia
Clinic Hospital Centre
Zareb, Croatia
Czech Republic
General University Hospital in Prague
Prague, Czech Republic
Hospital Teplice
Teplice, Czech Republic
France
Hopital Purpan
Toulouse, France
Germany
Judisches Krankenhaus Berlin
Berlin-Mitte, Germany
Hospital Neurologique et neuro-chirurgical Pierre Wertheimer
Bron Cedex, Germany
MS Zentrum
Dresden, Germany
Neurologische Klinik Heinrich-Heine-Universitat Dusseldorf
Dusseldorf, Germany
Klinkum der JW Goethe Universitat
Frankfurt am Main, Germany
Medizinische Hochshule Hannover
Hannover, Germany
Klinik Henningsdorf
Henningsdorf, Germany
Mexico
Hospital Medica Sur
Delegacion, Tlalpan, Mexico
Hospital Angeles del Pedregal; Camino a Santa Teresa No. 1055
Mexico City, Mexico
Poland
Centrum Neurologii Klinicznej
Krakow, Poland
Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny nr 1 UM w Lodzi
Lodz, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4
Lublin, Poland
Szpital Kliniczny im. Helidora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, Poland
Russian Federation
Research Medical Complex "Your Health" Ltd
Kazan, Russian Federation
Russian State Medical University
Moscow, Russian Federation
State Institution Scientific Neurology Center, RAMS
Moscow, Russian Federation
Moscow City Hospital #11
Moscow, Russian Federation
Municipal City Hospital #33
Nizhniy Novgorod, Russian Federation
Siberian District Medical Center
Novosibirsk, Russian Federation
City Clinical Hospital #2
Pyatigorsk, Russian Federation
Samara Regional Clinical Hospital n.a. Kalinin
Samara, Russian Federation
Institute of Human Brain RAS
St. Petersburg, Russian Federation
St. Petersburg Pavlov State Medical University
St. Petersburg, Russian Federation
Nikolaevskaya Hospital
St. Petersburg, Russian Federation
Republican Clinical Hospital
Ufa, Russian Federation
Serbia
Clinical Centre Srbija, Institute of Neurology
Belgrade, Serbia
Military Medical Academy
Belgrade, Serbia
Clinical centre Kragujeva
Kragujevac, Serbia
Clinical Center Nis. Center for Neurology
Nis, Serbia
Clinical Centre Vjovodina Institute of Neurology
Novi Sad, Serbia
Sweden
SU/Ostra sjukhuset MS Centrum
Gotenborg, Sweden
Ukraine
Institute of Neurology, Psychiatry and Narcology under the Academy of Sciences of Ukraine Department of Neuroinfection and Multiple Sclerosis
Kharkov, Ukraine
Kiev Municipal Clinical Hospital #4
Kiev, Ukraine
Hospoital of the Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Department
Kyiv, Ukraine
Danylo Halytsky Lviv National Medical University
Lviv, Ukraine
United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
The Royal London Hospital
London, England, United Kingdom
University Hospital of Wales, Clinical Research Facility
Cardiff, Wales, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
Sponsors and Collaborators
Genzyme, a Sanofi Company
Bayer
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00530348     History of Changes
Other Study ID Numbers: CAMMS323, ISRCTN21534255, ACTRN12608000435381, CARE-MS I
Study First Received: September 13, 2007
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration
Brazil: National Health Surveillance Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Croatia: Agency for Medicinal Product and Medical Devices
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Mexico: Federal Commission for Protection Against Health Risks
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Sweden: Medical Products Agency
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Genzyme, a Sanofi Company:
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Alemtuzumab
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Interferon beta 1a
Interferon-beta
Interferons
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014