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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00930553
First received: June 26, 2009
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

This open-label, rater-blinded extension study will enroll patients who have relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior Genzyme-sponsored studies of alemtuzumab [CAMMS223 (NCT00050778), CAMMS323 (NCT00530348) also known as CARE-MS I, or CAMMS324 (NCT00548405) also known as CARE-MS II]. The purposes of this study are:

  1. To examine the long term safety and efficacy of alemtuzumab treatment in patients who received alemtuzumab as their study treatment in one of the prior studies.
  2. To examine the safety and efficacy of initial alemtuzumab treatment in this study for patients who received Rebif® (interferon beta-1a) as their study treatment in one of the prior studies.
  3. To determine if and when further alemtuzumab treatment is needed, and the safety and efficacy of this "as needed" treatment. This applies both to patients who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.

Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Biological: alemtuzumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Time to Sustained Accumulation of Disability (SAD) [ Time Frame: Prior study baseline through Extension Month 48 ] [ Designated as safety issue: No ]
  • Relapse Rate [ Time Frame: Prior study baseline through Extension Month 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to sustained reduction in disability (SRD) as measured by the EDSS (Expanded Disability Status Scale) [ Time Frame: Prior study baseline through Extension Month 48 ] [ Designated as safety issue: No ]
  • Change over time in EDSS scores [ Time Frame: Prior study baseline through Extension Month 48 ] [ Designated as safety issue: No ]
  • Change over time in MRI findings [ Time Frame: Prior study baseline through Extension Month 48 ] [ Designated as safety issue: No ]
  • Change over time in self-reported quality of life as assessed by the Medical Outcome Study SF-36 Version 2, FAMS (Functional Assessment of Multiple Sclerosis), and EQ-5D findings [ Time Frame: Prior study baseline through Extension Month 48 ] [ Designated as safety issue: No ]

Enrollment: 1322
Study Start Date: August 2009
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Previously treated with alemtuzumab
Patients treated with alemtuzumab in prior Genzyme-sponsored studies of alemtuzumab who show documented evidence of resumed disease activity
Biological: alemtuzumab
12 mg per day administered through IV, once a day for 3 consecutive days (patients may receive additional cycles of alemtuzumab upon documented evidence of resumed disease activity, but not within same 12-month period)
Experimental: Previously treated with interferon beta-1a (Rebif®)
Patients treated with interferon beta-1a (Rebif®) in prior Genzyme-sponsored studies of alemtuzumab who meet treatment eligibility criteria.
Biological: alemtuzumab
12 mg per day administered through IV, once a day for 5 consecutive days during the first cycle and 12 mg per day administered through IV, once a day for 3 consecutive days during the second cycle, 12 months later. Patients may qualify for as-needed retreatment (12 mg per day administered through IV, once a day for 3 consecutive days) after their second fixed annual cycle.

Detailed Description:

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. Study duration may be extended per protocol amendments to allow patients to remain in the study through the time of drug approval or until a long term follow up study is available in each respective country.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  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: NCT00930553

  Hide Study Locations
Locations
United States, Alabama
North Central Neurology Associates, P.C.
Cullman, Alabama, United States
United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States
St. Joseph's Hospital and Medical Center Barrow Neurology Clinics - Barrow Neurological Institute
Phoenix, Arizona, United States
Mayo Clinic Arizona (Scottsdale)
Scottsdale, Arizona, United States
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, United States
United States, California
East Bay Physicians Medical Group/ Sutter East Bay Medical Foundation
Berkeley, California, United States
Neurology Center North Orange County
La Habra, California, United States
University of Southern California Keck School of Medicine/University of Southern California LAC & USC Medical Center
Los Angeles, California, United States
Neuro-Therapeutics, Inc.
Pasadena, California, United States
Stanford University Medical Center
Stanford, California, United States
United States, Colorado
University of Colorado Health Science Center - Aurora
Aurora, Colorado, United States
Advanced Neurology of Colorado
Ft. Collins, Colorado, United States
United States, Connecticut
Yale MS Research Center
New Haven, Connecticut, United States
United States, District of Columbia
The George Washington University Medical Faculty Associates
Washington, District of Columbia, United States
United States, Florida
University of Florida Neuroscience Institute
Jacksonville, Florida, United States
Neurology Associates, P.A.
Maitland, Florida, United States
Neurological Associates
Pompano Beach, Florida, United States
Negroski, Stein, Sutherland and Hanes Neurology
Sarasota, Florida, United States
University of South Florida College of Medicine
Tampa, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
United States, Georgia
Emory University Department of Neurology
Atlanta, Georgia, United States
Shepherd Center Multiple Sclerosis Institute
Atlanta, Georgia, United States
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States
Consultants in Neurology, LTD
Northbrook, Illinois, United States
United States, Indiana
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Indiana University Multiple Sclerosis Center
Indianapolis, Indiana, United States
United States, Iowa
Iowa Health Physicians
Des Moines, Iowa, United States
Ruan Neurology Clinic and Clinical Research Center, Mercy Medical Center
Des Moines, Iowa, United States
United States, Kansas
University of Kansas Medical Center, Department of Neurology
Kansas City, Kansas, United States
MidAmerica Neuroscience Institute
Lenexa, Kansas, United States
United States, Kentucky
Associates in Neurology, P.S.C.
Lexington, Kentucky, United States
Kentucky Neuroscience Research
Louisville, Kentucky, United States
United States, Maryland
University of Maryland, Maryland Center for MS
Baltimore, Maryland, United States
United States, Massachusetts
The MS Center at St. Elizabeth's
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
United States, Michigan
University of Michigan Medical School
Ann Arbor, Michigan, United States
Michigan Neurology Association
Clinton Twp, Michigan, United States
Wayne State University, The School of Medicine, Department of Neurology
Detroit, Michigan, United States
Spectrum Health Medical Group, Neurology/Michigan Medical P.C., West Michigan MS Clinic
Grand Rapids, Michigan, United States
Northern Michigan Neurology
Traverse City, Michigan, United States
United States, Missouri
Saint Luke's Brain & Stroke Institute
Kansas City, Missouri, United States
United States, Nevada
Renown Institute for Neurosciences
Reno, Nevada, United States
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
United States, New Jersey
MS Center at Holy Name Hospital
Teaneck, New Jersey, United States
United States, New Mexico
University of New Mexico, Dept. of Neurology
Albuquerque, New Mexico, United States
United States, New York
Empire Neurology P.C.
Latham, New York, United States
Winthrop University Hospital Multiple Sclerosis Treatment Center
Mineola, New York, United States
MS Care Center at NYUMC and HJD
New York, New York, United States
The Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai
New York, New York, United States
South Shore Neurologic Associates, P.C.
Patchogue, New York, United States
Rochester Multiple Sclerosis Center
Rochester, New York, United States
SUNY Upstate Medical University, Department of Neurology
Syracuse, New York, United States
United States, North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest University Health Science Department of Neurology
Winston Salem, North Carolina, United States
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oak Clinic for Multiple Sclerosis
Uniontown, Ohio, United States
United States, Oklahoma
OMRF Multiple Sclerosis Center of Excellence
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Lehigh Valley Hospital Neurosciences and Pain Research
Allentown, Pennsylvania, United States
United States, Rhode Island
Rhode Island Hospital MS Center - The Neurology Foundation, Inc
Providence, Rhode Island, United States
United States, Tennessee
Neurology Clinic PC
Cordova, Tennessee, United States
Advanced Neurosciences Institute
Franklin, Tennessee, United States
Hope Neurology
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, 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
Neurology Center of San Antonio
San Antonio, Texas, United States
Integra Clinical Research
San Antonio, Texas, United States
United States, Virginia
MS Center of Greater Washington
Vienna, Virginia, United States
United States, Washington
Swedish Medical MS Center
Seattle, Washington, United States
Argentina
DIABAID
Buenos Aires, Argentina
Australia, New South Wales
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Southern Neurology
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Australia, Queensland
Gold Coast Hospital
Southport, Queensland, Australia
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia
Australia, Victoria
St. Vincent's Hospital
Fitzroy, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Australia
The Wesley Research Institute
Auchenflower QLD, Australia
The Queen Elizabeth Hospital
Woodville, SA, Australia
Austria
AKH Wien-Universitätskliniken für Neurologie
Vienna, Austria
Belgium
Cliniques Universitaires Saint-luc
Brussel, Belgium
CHU Ourthe Amblève
Esneux, Belgium
University Hospital Leuven, Campus Gasthuisberg
Leuven, Belgium
Brazil
Hospital Mae de Deus
Porto Alegre, Brazil
Hospital da Restauração, Neurology department
Recife, PE, Brazil
Irmandade da Santa Casa de Misericórdio de São Paulo, Neurology department
São Paulo, SP, Brazil
Hospital das Clínicas da Faculdade de Medicina da USP, Neurology department
São Paulo,SP, Brazil
Canada, Alberta
University of Calgary, Department of Neurology
Calgary, Alberta, Canada
Canada, Ontario
Kingston General Hospital MS Clinic
Kingston, Ontario, Canada
Canada, Quebec
Clinique Neuro-Outaouais
Gatineau, Quebec, Canada
Recherche Sepmus, Inc.
Greenfield Park, Quebec, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Canada
London Health Sciences Centre - University Hospital
London, ON, Canada
The Ottawa Hospital - MS Research
Ottawa, Ontario, Canada
University of British Columbia
Vancouver, BC, Canada
Croatia
Clinical Hospital Osijek
Osijek, Croatia
Clinical Hospital Centre Rijeka
Rijeka, Croatia
General Hospital Varazdin, Department for Neurology
Varazdin, Croatia
Clinical Hospital Centre Zagreb
Zagreb, Croatia
Clinical Hospital Centre "Sestre Milosrdnice"
Zagreb, Croatia
Clinical Hospital Sveti Duh
Zagreb, Croatia
Czech Republic
St. Anne's University Hospital Brno
Brno, Czech Republic
University Hospital Hradec Králové
Hradec Kralove, Czech Republic
General Hospital, 128 21 Praha 2
Prague, Czech Republic
Hospital Teplice, Neurology Department, MS centrum
Teplice, Czech Republic
Denmark
Rigshospitalet Department of Neurology
Copenhagen, Denmark
Aarhus Sygehus
Århus C, Denmark
France
Hôpital Général
Dijon Cedex, France
Groupe Hospitalier Pitié-Salpêtrière, Fédération de Maladies du System Nerveux Central
Paris Cedex 13, France
CHU Pontchaillou
Rennes Cedex 9, France
Hôpital Civil
Strasbourg Cedex, France
CHU de Toulouse, Hôpital Purpan
Toulouse Cedex 9, France
Germany
Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn
Bonn, DE, Germany
Jüdisches Krankenhaus Berlin
Berlin-Mitte, Germany
Universitätsklinik Carl Gustav Carus Dresden
Dresden, Germany
Klinikum der JW Goethe Universität
Frankfurt am Main, Germany
Asklepios Klinik Barmbek
Hamburg, Germany
Medizinische Hochschule Hannover
Hannover, Germany
Oberhavel Klinicum GmbH - Krankenhaus Hennigsdorf
Hennigsdorf, Germany
Klinikum Ingolstadt
Ingolstadt, Germany
Klinikum rechts der Isar
München, Germany
Medizinische Fakultät der Universität Rostock,Zentrum für Nervenheilkunde
Rostock, Germany
Universitätsklinikum Ulm, Klinik für Neurologie im RKU
Ulm, Germany
Fachkrankenhaus Hubertusburg GmbH, Klinik für Neurologie und Neurologische Intensivmedizin
Wermsdorf, Germany
Israel
Hadassah Medical Center Ein Karem
Ein Karem, Jerusalem, Israel
Sheba Medical Center
Ramat Gan, Israel
Sourasky Tel Aviv Medical Center
Tel Aviv, Israel
Italy
Università di Cagliari
Cagliari, Italy
Ospedale S. Antonio Abate di Gallarate
Gallarate (Varese), Italy
Ospedale S. Luigi Gonzaga
Orbassano (TO), Italy
Universita Degli Studi di Roma "La Sapienza"
Roma, Italy
Mexico
Unidad de Investigación en Salud
Chihuahua, CHH, Mexico
Medica Sur
Mexico City, DFE, Mexico
Netherlands
Jeroen Bosch Ziekenhuis
Den Bosch, Netherlands
Orbis Medisch Concern
Sittard-Geleen, Netherlands
Poland
Centrum Neurologii Klinicznej Sp. Zo.o.
Krakow, Poland
Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny Nr1 im. Norberta Barlickiego
Lodz, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, Poland
Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Med. im. Karola Marcinkowskiego w Poznaniu
Poznan, Poland
Institute of Psychiatry and Neurology/Instytut Psychiatrii i Neurologii
Warsaw, Poland
Russian Federation
Research Medical Complex "Your Health" Ltd
Kazan, Russian Federation
Moscow State Public Medical Institution Clinical Hospital #11, Neurology Department
Moscow, Russian Federation
Neurology Research Center under the Russian Academy of Medical Sciences
Moscow, Russian Federation
Russian State Medical University, Department of Neurology and Neurosurgery
Moscow, Russian Federation
Municipal Treatment and Prevention Institution, City Hospital #33
Nizhny Novgorod, Russian Federation
Federal State Public Medical Institution: Siberian District Medical Center under the Federal Agency
Novosibirsk, Russian Federation
Municipal Public Medical Institution: City Hospital #2 of Pyatigorsk, Neurology Department
Pyatigorsk, Russian Federation
Samara Regional Clinical Hospital n.a. Kalinin
Samara, Russian Federation
St. Petersburg General Hospital #2, Neurology Department #2
St. Petersburg, Russian Federation
St Petersburg State Pavlov Medical University, Dept of Neurology and Neurosurgery with a Hospital
St. Petersburg, Russian Federation
Institute of Human Brain RAS, Laboratory of Neuroimmunology
St. Petersburg, Russian Federation
St. Petersburg State Public Medical Institution: Nikolayevskaya Hospital
St. Petersburg, Russian Federation
State Public Medical Institution: Republican Clinical Hospital n.a. G.G. Kuvatov
Ufa, Russian Federation
Serbia
Military Medical Academy, Institute of Neurology
Belgrade, Serbia
Clinical Centre Serbia, Institute of Neurology,Dr.Subotica 6,Belgrade
Belgrade, Serbia
Clinical Centre Kragujevac, Clinic of Neurology
Kragujevac, Serbia
Clinical Centre Nis, Clinic of Neurology
Nis, Serbia
Clinical Centre Vojvodina
Novi Sad, Serbia
Spain
Hospital Universitario Vall d' Hebron
Barcelona, Spain
Hospital Clínico Universitario San Carlos
Madrid, Spain
Hospital Carlos Haya, Neurology Service
Málaga, Spain
Hospital Virgen Macarena
Seville, Spain
Sweden
SU/Östra sjukhuset
Göteborg, Sweden
Norrlands Universitets sjukhus
Umeå, Sweden
Ukraine
Institute of Neurology, Psychiatry and Narcology under the AMS of Ukraine, Dep of Neuroinfection& MS
Kharkov, Ukraine
Kiev Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System
Kiev, Ukraine
Hospital of Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Dept.
Kiev-21, Ukraine
Lviv National Medical University n.a. Danylo Galytsky, Department of Neurology
Lviv, Ukraine
United Kingdom
Frenchay Hospital
Bristol, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
University Hospital of Wales, Dept of Neurology
Cardiff, United Kingdom
Royal London Hospital
London, United Kingdom
Salford Royal NHS Foundation Trust
Salford, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
Sponsors and Collaborators
Genzyme, a Sanofi Company
Bayer
Investigators
Study Director: Medical Monitor Genzyme Coorporation
  More Information

Publications:
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00930553     History of Changes
Other Study ID Numbers: CAMMS03409, 2009-010788-18
Study First Received: June 26, 2009
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Austria: Agency for Health and Food Safety
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency (ANVISA)
Canada: Health Canada
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Israel: Ministry of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: Medical Ethics Review Committee (METC)
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
Spain: Ministry of Health
Sweden: Medical Products Agency
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sanofi:
Multiple Sclerosis

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

ClinicalTrials.gov processed this record on October 23, 2014