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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00930553
Other study ID # CAMMS03409
Secondary ID 2009-010788-18LT
Status Completed
Phase Phase 3
First received June 26, 2009
Last updated March 11, 2016
Start date August 2009
Est. completion date February 2016

Study information

Verified date March 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationArgentina: Ministry of HealthAustria: Agency for Health and Food SafetyAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsBrazil: National Health Surveillance Agency (ANVISA)Canada: Health CanadaCroatia: Ministry of Health and Social CareCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutIsrael: Ministry of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthMexico: Federal Commission for Sanitary Risks ProtectionNetherlands: Medical Ethics Review Committee (METC)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSpain: Ministry of HealthSweden: Medical Products AgencyUkraine: State Pharmacological Center - Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1322
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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).

Study Design

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


Related Conditions & MeSH terms


Intervention

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)
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.

Locations

Country Name City State
Argentina DIABAID Buenos Aires
Australia The Wesley Research Institute Auchenflower QLD
Australia Concord Repatriation General Hospital Concord New South Wales
Australia St. Vincent's Hospital Fitzroy Victoria
Australia Austin Health Heidelberg Victoria
Australia Royal Hobart Hospital Hobart Tasmania
Australia Southern Neurology Kogarah New South Wales
Australia Liverpool Hospital Liverpool New South Wales
Australia Royal Melbourne Hospital Parkville Victoria
Australia Gold Coast Hospital Southport Queensland
Australia Westmead Hospital Westmead New South Wales
Australia The Queen Elizabeth Hospital Woodville, SA
Austria AKH Wien-Universitätskliniken für Neurologie Vienna
Belgium Cliniques Universitaires Saint-luc Brussel
Belgium CHU Ourthe Amblève Esneux
Belgium University Hospital Leuven, Campus Gasthuisberg Leuven
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
Canada University of Calgary, Department of Neurology Calgary Alberta
Canada Clinique Neuro-Outaouais Gatineau Quebec
Canada Recherche Sepmus, Inc. Greenfield Park Quebec
Canada Kingston General Hospital MS Clinic Kingston Ontario
Canada London Health Sciences Centre - University Hospital London, ON
Canada Hopital Maisonneuve-Rosemont Montreal Quebec
Canada The Ottawa Hospital - MS Research Ottawa, Ontario
Canada University of British Columbia Vancouver, BC
Croatia Clinical Hospital Osijek Osijek
Croatia Clinical Hospital Centre Rijeka Rijeka
Croatia General Hospital Varazdin, Department for Neurology Varazdin
Croatia Clinical Hospital Centre "Sestre Milosrdnice" Zagreb
Croatia Clinical Hospital Centre Zagreb Zagreb
Croatia Clinical Hospital Sveti Duh Zagreb
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
Denmark Aarhus Sygehus Århus C
Denmark Rigshospitalet Department of Neurology Copenhagen
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
Germany Jüdisches Krankenhaus Berlin Berlin-Mitte
Germany Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn Bonn DE
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
Israel Hadassah Medical Center Ein Karem Ein Karem, Jerusalem
Israel Sheba Medical Center Ramat Gan
Israel Sourasky Tel Aviv Medical Center Tel Aviv
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
Mexico Unidad de Investigación en Salud Chihuahua, CHH
Mexico Medica Sur Mexico City, DFE
Netherlands Jeroen Bosch Ziekenhuis Den Bosch
Netherlands Orbis Medisch Concern Sittard-Geleen
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
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 Institute of Human Brain RAS, Laboratory of Neuroimmunology St. Petersburg
Russian Federation St Petersburg State Pavlov Medical University, Dept of Neurology and Neurosurgery with a Hospital St. Petersburg
Russian Federation St. Petersburg General Hospital #2, Neurology Department #2 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
Serbia Clinical Centre Serbia, Institute of Neurology,Dr.Subotica 6,Belgrade Belgrade
Serbia Military Medical Academy, Institute of Neurology Belgrade
Serbia Clinical Centre Kragujevac, Clinic of Neurology Kragujevac
Serbia Clinical Centre Nis, Clinic of Neurology Nis
Serbia Clinical Centre Vojvodina Novi Sad
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
Sweden SU/Östra sjukhuset Göteborg
Sweden Norrlands Universitets sjukhus Umeå
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
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 States University of New Mexico, Dept. of Neurology Albuquerque New Mexico
United States Lehigh Valley Hospital Neurosciences and Pain Research Allentown Pennsylvania
United States University of Michigan Medical School Ann Arbor Michigan
United States Emory University Department of Neurology Atlanta Georgia
United States Shepherd Center Multiple Sclerosis Institute Atlanta Georgia
United States University of Colorado Health Science Center - Aurora Aurora Colorado
United States University of Maryland, Maryland Center for MS Baltimore Maryland
United States East Bay Physicians Medical Group/ Sutter East Bay Medical Foundation Berkeley California
United States The MS Center at St. Elizabeth's Boston Massachusetts
United States The University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States University of Chicago Medical Center Chicago Illinois
United States Cleveland Clinic Foundation Cleveland Ohio
United States Michigan Neurology Association Clinton Twp Michigan
United States Neurology Clinic PC Cordova Tennessee
United States North Central Neurology Associates, P.C. Cullman Alabama
United States Iowa Health Physicians Des Moines Iowa
United States Ruan Neurology Clinic and Clinical Research Center, Mercy Medical Center Des Moines Iowa
United States Wayne State University, The School of Medicine, Department of Neurology Detroit Michigan
United States Fort Wayne Neurological Center Fort Wayne Indiana
United States Advanced Neurosciences Institute Franklin Tennessee
United States Advanced Neurology of Colorado Ft. Collins Colorado
United States Spectrum Health Medical Group, Neurology/Michigan Medical P.C., West Michigan MS Clinic Grand Rapids Michigan
United States Baylor College of Medicine, Maxine Mesinger MS Clinic Houston Texas
United States Indiana University Multiple Sclerosis Center Indianapolis Indiana
United States University of Florida Neuroscience Institute Jacksonville Florida
United States Saint Luke's Brain & Stroke Institute Kansas City Missouri
United States University of Kansas Medical Center, Department of Neurology Kansas City Kansas
United States Hope Neurology Knoxville Tennessee
United States Neurology Center North Orange County La Habra California
United States Empire Neurology P.C. Latham New York
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States MidAmerica Neuroscience Institute Lenexa Kansas
United States Associates in Neurology, P.S.C. Lexington Kentucky
United States University of Southern California Keck School of Medicine/University of Southern California LAC & USC Medical Center Los Angeles California
United States Kentucky Neuroscience Research Louisville Kentucky
United States Neurology Associates, P.A. Maitland Florida
United States Winthrop University Hospital Multiple Sclerosis Treatment Center Mineola New York
United States Vanderbilt University Medical Center Nashville Tennessee
United States Yale MS Research Center New Haven Connecticut
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 Consultants in Neurology, LTD Northbrook Illinois
United States OMRF Multiple Sclerosis Center of Excellence Oklahoma City Oklahoma
United States Neuro-Therapeutics, Inc. Pasadena California
United States South Shore Neurologic Associates, P.C. Patchogue New York
United States HOPE Research Institute Phoenix Arizona
United States St. Joseph's Hospital and Medical Center Barrow Neurology Clinics - Barrow Neurological Institute Phoenix Arizona
United States Neurological Associates Pompano Beach Florida
United States Rhode Island Hospital MS Center - The Neurology Foundation, Inc Providence Rhode Island
United States Renown Institute for Neurosciences Reno Nevada
United States Rochester Multiple Sclerosis Center Rochester New York
United States Central Texas Neurology Consultants Round Rock Texas
United States Integra Clinical Research San Antonio Texas
United States Neurology Center of San Antonio San Antonio Texas
United States Negroski, Stein, Sutherland and Hanes Neurology Sarasota Florida
United States Mayo Clinic Arizona (Scottsdale) Scottsdale Arizona
United States Swedish Medical MS Center Seattle Washington
United States Stanford University Medical Center Stanford California
United States SUNY Upstate Medical University, Department of Neurology Syracuse New York
United States Axiom Clinical Research of Florida Tampa Florida
United States University of South Florida College of Medicine Tampa Florida
United States MS Center at Holy Name Hospital Teaneck New Jersey
United States Northern Michigan Neurology Traverse City Michigan
United States Northwest NeuroSpecialists, PLLC Tucson Arizona
United States Oak Clinic for Multiple Sclerosis Uniontown Ohio
United States MS Center of Greater Washington Vienna Virginia
United States The George Washington University Medical Faculty Associates Washington District of Columbia
United States Wake Forest University Health Science Department of Neurology Winston Salem North Carolina
United States UMass Memorial Medical Center Worcester Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Genzyme, a Sanofi Company Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Croatia,  Czech Republic,  Denmark,  France,  Germany,  Israel,  Italy,  Mexico,  Netherlands,  Poland,  Russian Federation,  Serbia,  Spain,  Sweden,  Ukraine,  United Kingdom, 

References & Publications (3)

CAMMS223 Trial Investigators, Coles AJ, Compston DA, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med. 2008 Oct 23;359(17):1786-801. doi: 10.1056/NEJMoa0802670. — View Citation

Coles AJ, Cox A, Le Page E, Jones J, Trip SA, Deans J, Seaman S, Miller DH, Hale G, Waldmann H, Compston DA. The window of therapeutic opportunity in multiple sclerosis: evidence from monoclonal antibody therapy. J Neurol. 2006 Jan;253(1):98-108. Epub 2005 Jul 27. — View Citation

Fox E, Sullivan H, Gazda S. Open label, single-arm, Phase II study of alemtuzumab in patients with active relapsing-remitting multiple sclerosis who have failed licensed beta-interferon therapies. Poster presentation P06.07 at the 59th Annual Meeting of the American Academy of Neurology (AAN) on 03 May 2007.

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Sustained Accumulation of Disability (SAD) Prior study baseline through Extension Month 48 No
Primary Relapse Rate Prior study baseline through Extension Month 48 No
Secondary Time to sustained reduction in disability (SRD) as measured by the EDSS (Expanded Disability Status Scale) Prior study baseline through Extension Month 48 No
Secondary Change over time in EDSS scores Prior study baseline through Extension Month 48 No
Secondary Change over time in MRI findings Prior study baseline through Extension Month 48 No
Secondary 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 Prior study baseline through Extension Month 48 No
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