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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001162-32 | EudraCT Number | ||
| CAMMS324, | |||
| ISRCTN70702834 | Registry Identifier | ISRCTN | |
| ACTRN12608000426381 | Registry Identifier | ANZCTR | |
| NTR1469 | Registry Identifier | The Netherlands National Trial Register | |
| CARE-MS II | Other Identifier | NMSS |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequate trial of disease-modifying therapies but experienced at least 1 relapse during prior treatment, and who met a minimum severity of disease as measured by magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive testing every 3 months.
Every participant received active treatment; there was no placebo. After Amendment 2, the 24 mg alemtuzumab dose was closed to enrollment so newly enrolled participants were randomly assigned to treatment with either 12 mg alemtuzumab or interferon beta-1a in a 2:1 ratio (that is, 2 given 12 mg alemtuzumab for every 1 given interferon beta-1a). Alemtuzumab was administered in two annual courses, once at the beginning of the study and again 1 year later. Interferon beta-1a was self-injected 3 times per week for 2 years. All participants were required to return to their study site every 3 months for neurologic assessment. In addition, safety-related laboratory tests were performed at least monthly. Participation in this study ended 2 years after the start of treatment for each participant. Additionally, participants who received alemtuzumab might be followed in the CAMMS03409 Extension Study (NCT00930553) for safety and efficacy assessments. Participants who received interferon beta-1a and completed 2 years on study might be eligible to receive alemtuzumab in the Extension Study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alemtuzumab 12 mg | Experimental | Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12. |
|
| Alemtuzumab 24 mg | Experimental | Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12. |
|
| Interferon Beta-1a | Active Comparator | Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alemtuzumab 12 mg | Biological | Alemtuzumab 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Accumulation of Disability (SAD) | EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least the next 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported. | Up to 2 years |
| Annualized Relapse Rate | Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Were Relapse Free at Year 2 | Participants were considered relapse free at Year 2 if they did not experience a relapse from the date of first study treatment to study completion at 24 months. Percentage of participants who were relapse free at Year 2, estimated using the KM method, was reported. | Year 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Central Neurology Associates, P.C. | Cullman | Alabama | United States | |||
| Barrow Neurological Institute, St. Joseph's Hospital and Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23122650 | Background | Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Miller T, Fisher E, Sandbrink R, Lake SL, Margolin DH, Oyuela P, Panzara MA, Compston DA; CARE-MS II investigators. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1829-39. doi: 10.1016/S0140-6736(12)61768-1. Epub 2012 Nov 1. | |
| 39935588 |
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Participants were screened at 192 investigational sites between October 10, 2007 and September 15, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Interferon Beta-1a | Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion. |
| FG001 | Alemtuzumab 12 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Alemtuzumab 24 mg | Biological | Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12. |
|
|
| Interferon beta-1a | Biological | Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion. |
|
|
| Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2 |
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2. |
| Baseline, Year 2 |
| Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2 | MSFC is a multidimensional measure consisting of quantitative tests of ambulation (Timed 25-Foot Walk), manual dexterity (9-Hole Peg Test; 9HPT), and cognitive function (Paced Auditory Serial Addition Test; PASAT). The MSFC score was calculated as the mean of the Z-scores of the 3 components. A Z-score was calculated by subtracting the mean of the reference population from the test result, then dividing by the standard deviation of the reference population. Higher Z-scores reflected better neurological function and a positive change from Baseline indicates improvement. An increase in score indicated an improvement (Z-score range: -3 to +3). Acquisition of disability was measured by change from Baseline in MSFC score at Year 2. | Baseline, Year 2 |
| Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2 | Percent change in MS lesion volume as measured by MRI-T2 scan was calculated from MRI-T2-weighted scans as the following: (lesion volume at 2 years - lesion volume at Baseline)*100/ (lesion volume at Baseline). | Baseline, Year 2 |
| Phoenix |
| Arizona |
| United States |
| Hope Research Institute | Phoenix | Arizona | United States |
| Mayo Clinic Arizona, Department of Neurology | Scottsdale | Arizona | United States |
| Northwest NeuroSpecialists, PLLC | Tucson | Arizona | United States |
| East Bay Physicians Medical Group/Sutter East Bay Medical Foundation | Berkeley | California | United States |
| Neurology Center of North Orange County | La Habra | California | United States |
| Department of Neurology, Keck School of Medicine, University of Southern California | Los Angeles | California | United States |
| Neuro-Therapeutics Inc. | Pasadena | California | United States |
| Neuro-Therapeutics, Inc | Pasadena | California | United States |
| University of California, Davis Medical Center | Sacramento | California | United States |
| Stanford University School of Medicine | Stanford | California | United States |
| University of Colorado Hospital, Anschutz Outpatient Pavilioin | Aurora | Colorado | United States |
| Neurological Consultants | Denver | Colorado | United States |
| Advanced Neurosciences Research | Fort Collins | Colorado | United States |
| Yale University | New Haven | Connecticut | United States |
| George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | United States |
| 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 |
| Axiom Clinical Research of Florida | Tampa | Florida | United States |
| University of South Florida, Department of Neurology | Tampa | Florida | United States |
| Emory University, Department of Neurology | Atlanta | Georgia | United States |
| Shepherd Center, Inc. | Atlanta | Georgia | United States |
| Idaho Falls Multiple Sclerosis Center, PLLC | Idaho Falls | Idaho | United States |
| University of Chicago Medical Center, Department of Neurology | Chicago | Illinois | United States |
| Consultants in Neurology, Ltd | Northbrook | Illinois | United States |
| Fort Wayne Neurological Center | Fort Wayne | Indiana | United States |
| Indiana University School of Medicine, Department of Neurology | Indianapolis | Indiana | United States |
| Josephson Wallack Munshower Neurology P.C. | Indianapolis | Indiana | United States |
| Iowa Health Physicians | Des Moines | Iowa | United States |
| Ruan Neurology Clinic and Research Center | Des Moines | Iowa | United States |
| University of Kansas Medical Center, Department of Neurology | Kansas City | Kansas | United States |
| MidAmerica Neuroscience Institute | Lenexa | Kansas | United States |
| Associates in Neurology, PSC | Lexington | Kentucky | United States |
| University of Louisville Research Foundation | Louisville | Kentucky | United States |
| Louisiana State University Health Sciences Center | Shreveport | Louisiana | United States |
| Caritas St. Elizabeth's Medical Center | Boston | Massachusetts | United States |
| Partners Multiple Sclerosis Center/Brigham and Women's Hospital | Boston | Massachusetts | United States |
| Springfield Neurology Associates, LLC | Springfield | Massachusetts | United States |
| UMass Memorial Medical Center | Worcester | Massachusetts | United States |
| University of Michigan Department of Neurology | Ann Arbor | Michigan | United States |
| Henry Ford Hospital | Detroit | Michigan | United States |
| Wayne State University, School of Medicine, Department of Neurology | Detroit | Michigan | United States |
| Spectrum Health Medical Group, Neurology (Previously known as Michigan Medical P.C., Neurology) | Grand Rapids | Michigan | United States |
| Michigan Neurology Associates, P.C. | Saint Clair Shores | Michigan | United States |
| Northern Michigan Neurology | Traverse City | Michigan | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | United States |
| Neurology Consultants of Kansas City, Inc. | Kansas City | Missouri | United States |
| Montana Neurobehavioral Specialists | Missoula | Montana | United States |
| University of Nevada School of Medicine | Las Vegas | Nevada | United States |
| Renown Institute for Neurosciences / Renown regional Medical Center | Reno | Nevada | United States |
| Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center | Lebanon | New Hampshire | United States |
| MS Center at Holy Name Hospital | Teaneck | New Jersey | United States |
| University of New Mexico, Health Sciences Center, MS Specialty Clinic | Albuquerque | New Mexico | United States |
| Empire Neurology, PC | Latham | New York | United States |
| Winthrop University Hospital, Clinical Trials Center | Mineola | New York | United States |
| Mount Sinai School of Medicine, Corinne Goldsmith Dickinson Center for Multiple Sclerosis | 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 |
| SUNY Upstate Medical University, Department of Neurology | Syracuse | New York | United States |
| University of North Carolina-Chapel Hill, Department of Neurology | Chapel Hill | North Carolina | United States |
| Wake Forest University Health Science, Department of Neurology | Winston-Salem | North Carolina | United States |
| Cleveland Clinic Foundation, Mellen Center | Cleveland | Ohio | United States |
| Neurology Specialists, Inc. | Dayton | Ohio | United States |
| Oak Clinic for Multiple Sclerosis | Uniontown | Ohio | United States |
| MS Center of Oklahoma | Oklahoma City | Oklahoma | United States |
| Lehigh Valley Hospital, Neuroscience and Pain Research | Allentown | Pennsylvania | United States |
| Northshore Clinical Associates | Erie | Pennsylvania | United States |
| University of Pittsburgh, Kaufmann Medical Building | Pittsburgh | Pennsylvania | United States |
| The Neurology Foundation, Inc. | Providence | Rhode Island | United States |
| Neurology Clinic, P.C. | Cordova | Tennessee | United States |
| Advanced Neurosciences Institute | Franklin | Tennessee | United States |
| Biomedical Research Alliance of NY, LLC | Franklin | Tennessee | United States |
| Hope Neurology PC | Knoxville | Tennessee | United States |
| Vanderbilt Multiple Sclerosis Center | Nashville | Tennessee | United States |
| Clinical Center for Multiple Sclerosis | Dallas | Texas | United States |
| Central Texas Neurology | Round Rock | Texas | United States |
| Integra Clinical Research | San Antonio | Texas | United States |
| Neurology Center of San Antonio | San Antonio | Texas | United States |
| MS Center of Greater Washington, P.C. | Vienna | Virginia | United States |
| Swedish Neuroscience Institute | Seattle | Washington | United States |
| Virginia Mason Medical Center | Seattle | Washington | United States |
| Rockwood Clinical Research Center | Spokane | Washington | United States |
| DIABAID | Buenos Aires | Argentina |
| Westmead Hospital | Westmead | New South Wales | Australia |
| The Wesley Research Institute | Auchenflower | Queensland | 4066 | Australia |
| Griffith School of Medicine, Gold Coast Campus, Griffith University | Southport | Queensland | Australia |
| Clinical Cognitive Research Unit/Clinical Trials, The Queen Elizabeth Hospital, Neurology Department | Woodville South | South Australia | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| St. Vincent's Hospital, MS Education & Research, Department of Clinical Neurosciences | Fitzroy | Victoria | Australia |
| Austin Health | Heidelberg | Victoria | Australia |
| Royal Melbourne Hospital, Department of Neurology | Parkville | Victoria | 3050 | Australia |
| Concord Repatriation General Hospital, Neurosciences Department | Concord | Australia |
| Southern Neurology | Kogarah | Australia |
| Liverpool Hospital, Neurology Department | Liverpool | 2170 | Australia |
| AKH Wien, Universitätsklinikum für Neurologie | Vienna | Austria |
| Cliniques Universitaires Saint-Luc, Neurology | Brussels | Belgium |
| CHU Ourthe Amblève, Neurology | Esneux | Belgium |
| University Hospital Leuven, Campus Gasthuisberg, Neurology | Leuven | Belgium |
| Hospital da Restauracao | Recife | Pernambuco | Brazil |
| Hospital Sao Lucas PUC-RS | Porto Alegre | Rio Grande do Sul | Brazil |
| Hospital de Clínicas USP | São Paulo | Brazil |
| Irmandade da Santa Casa de Misericordia de Sao Paulo | São Paulo | Brazil |
| UBC Hospital | Vancouver | British Columbia | Canada |
| Multiple Sclerosis Clinic, Connell 7, Kingston General Hospital | Kingston | Ontario | Canada |
| London Health Sciences Centre- University Hospital | London | Ontario | Canada |
| The Ottawa Hospital, General Campus | Ottawa | Ontario | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |
| Centre de Sante et de Services Sociaux de Gatineau-Hull Hospital | Gatineau | Quebec | Canada |
| Clinique Neuro rive-sud, Recherche sepmus inc | Greenfield Park | Quebec | Canada |
| Hospital Maisonneuve-Rosemont | Montreal | Quebec | Canada |
| Montreal Neurological Institute and Hospital | Montreal | Quebec | Canada |
| Clinical Hospital Centre Rijeka, Clinic for Neurology | Rijeka | Croatia |
| General Hospital Varazdin, Department of neurology | Varaždin | Croatia |
| Clinical Hospital Centre Zagreb | Zagreb | Croatia |
| Clinical Hospital Sestre Milosrdnice | Zagreb | Croatia |
| General Hospital " Sveti Duh", Department of neurology | Zagreb | Croatia |
| MS Center, Department of Neurology | Hradec Králové | Czechia |
| St. Anne's University Hospital Brno | Pekarska | Czechia |
| Department of Neurology 1st Faculty of Medicine and General Teaching Hospital, MS Center | Prague | Czechia |
| Krajska zdravotni a.s. - Hospital Teplice | Teplice | Czechia |
| Århus Universitetshospital, Scleroseklinikken, Århus Sygehus | Aarhus | Denmark |
| Scleroseklinikken, Rigshospitalet | Copenhagen | Denmark |
| Odense University Hospital | Odense | Denmark |
| CHU Clermont-Ferrand, Hôpital Gabriel Montpied | Clermont-Ferrand | France |
| Hôpital General, Service de Neurologie | Dijon | France |
| Hospital Roger Salengro | Lille | France |
| Hôpital Pitié Salpétrière, Service de Neurologie | Paris | France |
| Sevice de Neurologie | Rennes | France |
| Hôpital Civil, Departement de Neurologie | Strasbourg | France |
| Krankenhaus Hohe Warte, Betriebsstätte der Bayreuth | Bayreuth | Germany |
| Judisches Krankenhaus Berlin | Berlin | Germany |
| Neurologisches Fachzentrum Berlin | Berlin | Germany |
| Neurologische Universitätsklinik Bonn | Bonn | Germany |
| Multiple Sklerose Zentrum am, Zentrum für klinische Neurowissenschaften, Neurologische Uniklinik Dresden | Dresden | Germany |
| Asklepios Klinic Barmbek | Hamburg | Germany |
| Medizinische Hochshule Hannover | Hanover | Germany |
| Oberhavelkliniken Hennigsdorf | Hennigsdorf | Germany |
| Klinikum Ingolstadt, Neurologische Klinik | Ingolstadt | Germany |
| Klinikum Rechts der Isar, Klinik für Neurologie | München | Germany |
| Klinik und Poliklinik fur Neurologie der Universitat Rockstock | Rostock | Germany |
| Universitatsklinik Ulm | Ulm | Germany |
| Fachkrankenhaus Hubertusburg | Wermsdorf | Germany |
| Hadassah Medical Center Ein Karem | Jerusalem | Israel |
| Tel Aviv Sourasky Medical Center, Department of Neurology | Tel Aviv | Israel |
| Sheba Medical Centre | Tel Litwinsky | Israel |
| Ospedale Binaghi - Centro Sclerosi Multipla | Cagliari | Italy |
| Ospedale S. Antonio Abate di Gallarate | Gallarate | Italy |
| Università di Genova Dipartimento di Neuroscienze Oftalmologia e Genetica | Genova | Italy |
| Ospedale Civile di Brescia c/o Ospedale Richiedei, Centro di riferimento per la Sclerosi Multiple | Montichiari | Italy |
| Ospedale San Luigi di Orbassano | Orbassano | Italy |
| Azienda Ospedaliera Sant'Andrea Neurologia | Roma | Italy |
| Unidad de Investigación en Salud de Chihuahua, S.C. | Chihuahua City | Chihuahua | Mexico |
| Hospital Medica Sur CIF-BIOTEC | Delegacion | Tlalpan | Mexico |
| Hospital Angeles del Pedregal; Camino a Santa Teresa | Mexico City | Mexico |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | Netherlands |
| Orbis Medisch Centrum, Department of Neurology | Sittard | Netherlands |
| Independent Public Healthcare Facility, Norbert Barlicki University Hospital No. 1 of the Medical University of Lodz | Lodz | Poland |
| Independent Public Teaching Hospital No. 4 in Lublin | Lublin | Poland |
| Heliodor Swiecicki Teaching Hospital of the Poznan, University of Medical Sciences | Poznan | Poland |
| Research Medical Complex "Your Health" Ltd | Kazan' | Russia |
| Institution of the Russian Academy of Medical Sciences, "Neurology Scientific Center under RAMS" | Moscow | Russia |
| Moscow State Medical Institution City Clinical Hospital #11, Moscow City Center for Multiple Sclerosis | Moscow | Russia |
| Moscow State Public Medical Institution, City Clinical Hospital #11 | Moscow | Russia |
| Municipal Treatment and Prevention Institution, "City Hospital #33" | Nizhny Novgorod | Russia |
| Federal State Institution: Siberian District Medical Center | Novosibirsk | Russia |
| Institution of the Russian Academy of Sciences, "Institute of the Human Brain n.a. N.P. Bekhtereva within the Russian Academy of Sciences" | Saint Petersburg | Russia |
| St. Petersburg Pavlov State Medical University, Department of Neurology and Neurosurgery with a Clinic | Saint Petersburg | Russia |
| St.Petersburg State Medical Institution, "City Multispecialty Hospital #2" | Saint Petersburg | Russia |
| St.Petersburg State Medical Institution, "Nikolayevskaya Hospital" | Saint Petersburg | Russia |
| State Medical Institution, "Samara Regional Clinical Hospital n.a. M.I. Kalinin" | Samara | Russia |
| Clinic of Neurology, Clinical Centre of Serbia | Belgrade | Serbia |
| Military Medical Academy | Belgrade | Serbia |
| Clinical Centre of Kragujevac | Kragujevac | Serbia |
| Clinical Centre Vojvodina Institute of Neurology | Novi Sad | Serbia |
| Servicio de Neurología Hospital Vall d'Hebron Paseo de Vall d'Hebron | Barcelona | Spain |
| Servicio de Neurología Hospital Clínico San Carlos | Madrid | Spain |
| Servicio de Neurología Hospital Carlos Haya | Málaga | Spain |
| Servicio de Neurología Hospital Virgen de la Macarena | Seville | Spain |
| Sahlgrenska University Hospital, Neurologkliniken | Gothenburg | Sweden |
| Norrlands Universitets sjukhus | Umeå | Sweden |
| Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine | Kharkiv | Ukraine |
| Kyiv Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System | Kyiv | Ukraine |
| Danylo Halytsky Lviv National Medical University, Department of Neurology | Lviv | Ukraine |
| Department Of Neurosciences, Addenbrookes Hospital | Cambridge | England | United Kingdom |
| Centre for Neuroscience & Trauma, Blizard Institute of Cell and Molecular Science Barts and The London School of Medicine and Dentistry | London | England | United Kingdom |
| Frenchay Hospital | Bristol | United Kingdom |
| Salford Royal NHS Foundation Trust, Clinical Trials Unit | Salford | United Kingdom |
| Department of Neurology Glossop Road, Royal Hallamshire Hospital | Sheffield | United Kingdom |
| Derived |
| Ziemssen T, Bass AD, Van Wijmeersch B, Eichau S, Richter S, Hoffmann F, Armstrong NM, Chirieac M, Cunha-Santos J, Singer BA. Long-term efficacy and safety of alemtuzumab in participants with highly active MS: TOPAZ clinical trial and interim analysis of TREAT-MS real-world study. Ther Adv Neurol Disord. 2025 Feb 10;18:17562864241306575. doi: 10.1177/17562864241306575. eCollection 2025. |
| 37745914 | Derived | Coles AJ, Achiron A, Traboulsee A, Singer BA, Pozzilli C, Oreja-Guevara C, Giovannoni G, Comi G, Freedman MS, Ziemssen T, Shiota D, Rawlings AM, Wong AT, Chirieac M, Montalban X. Safety and efficacy with alemtuzumab over 13 years in relapsing-remitting multiple sclerosis: final results from the open-label TOPAZ study. Ther Adv Neurol Disord. 2023 Sep 21;16:17562864231194823. doi: 10.1177/17562864231194823. eCollection 2023. |
| 37272540 | Derived | Riera R, Torloni MR, Martimbianco ALC, Pacheco RL. Alemtuzumab for multiple sclerosis. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD011203. doi: 10.1002/14651858.CD011203.pub3. |
| 36619856 | Derived | Dayan CM, Lecumberri B, Muller I, Ganesananthan S, Hunter SF, Selmaj KW, Hartung HP, Havrdova EK, LaGanke CC, Ziemssen T, Van Wijmeersch B, Meuth SG, Margolin DH, Poole EM, Baker DP, Senior PA. Endocrine and multiple sclerosis outcomes in patients with autoimmune thyroid events in the alemtuzumab CARE-MS studies. Mult Scler J Exp Transl Clin. 2023 Jan 3;9(1):20552173221142741. doi: 10.1177/20552173221142741. eCollection 2023 Jan-Mar. |
| 34882037 | Derived | Coles AJ, Jones JL, Vermersch P, Traboulsee A, Bass AD, Boster A, Chan A, Comi G, Fernandez O, Giovannoni G, Kubala Havrdova E, LaGanke C, Montalban X, Oreja-Guevara C, Piehl F, Wiendl H, Ziemssen T. Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data. Mult Scler. 2022 Apr;28(5):842-846. doi: 10.1177/13524585211061335. Epub 2021 Dec 9. |
| 34035833 | Derived | Coles AJ, Arnold DL, Bass AD, Boster AL, Compston DAS, Fernandez O, Havrdova EK, Nakamura K, Traboulsee A, Ziemssen T, Jacobs A, Margolin DH, Huang X, Daizadeh N, Chirieac MC, Selmaj KW. Efficacy and safety of alemtuzumab over 6 years: final results of the 4-year CARE-MS extension trial. Ther Adv Neurol Disord. 2021 Apr 23;14:1756286420982134. doi: 10.1177/1756286420982134. eCollection 2021. |
| 33414927 | Derived | Horakova D, Boster A, Bertolotto A, Freedman MS, Firmino I, Cavalier SJ, Jacobs AK, Thangavelu K, Daizadeh N, Poole EM, Baker DP, Margolin DH, Ziemssen T; CARE-MS I, CARE-MS II, and CAMMS03409 Investigators. Proportion of alemtuzumab-treated patients converting from relapsing-remitting multiple sclerosis to secondary progressive multiple sclerosis over 6 years. Mult Scler J Exp Transl Clin. 2020 Dec 18;6(4):2055217320972137. doi: 10.1177/2055217320972137. eCollection 2020 Oct-Dec. |
| 32710396 | Derived | Ziemssen T, Bass AD, Berkovich R, Comi G, Eichau S, Hobart J, Hunter SF, LaGanke C, Limmroth V, Pelletier D, Pozzilli C, Schippling S, Sousa L, Traboulsee A, Uitdehaag BMJ, Van Wijmeersch B, Choudhry Z, Daizadeh N, Singer BA; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Efficacy and Safety of Alemtuzumab Through 9 Years of Follow-up in Patients with Highly Active Disease: Post Hoc Analysis of CARE-MS I and II Patients in the TOPAZ Extension Study. CNS Drugs. 2020 Sep;34(9):973-988. doi: 10.1007/s40263-020-00749-x. |
| 32539719 | Derived | Gilmore W, Lund BT, Li P, Levy AM, Kelland EE, Akbari O, Groshen S, Cen SY, Pelletier D, Weiner LP, Javed A, Dunn JE, Traboulsee AL. Repopulation of T, B, and NK cells following alemtuzumab treatment in relapsing-remitting multiple sclerosis. J Neuroinflammation. 2020 Jun 15;17(1):189. doi: 10.1186/s12974-020-01847-9. |
| 31762387 | Derived | Comi G, Alroughani R, Boster AL, Bass AD, Berkovich R, Fernandez O, Kim HJ, Limmroth V, Lycke J, Macdonell RA, Sharrack B, Singer BA, Vermersch P, Wiendl H, Ziemssen T, Jacobs A, Daizadeh N, Rodriguez CE, Traboulsee A; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies. Mult Scler. 2020 Dec;26(14):1866-1876. doi: 10.1177/1352458519888610. Epub 2019 Nov 25. |
| 31675266 | Derived | Van Wijmeersch B, Singer BA, Boster A, Broadley S, Fernandez O, Freedman MS, Izquierdo G, Lycke J, Pozzilli C, Sharrack B, Steingo B, Wiendl H, Wray S, Ziemssen T, Chung L, Margolin DH, Thangavelu K, Vermersch P. Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies. Mult Scler. 2020 Nov;26(13):1719-1728. doi: 10.1177/1352458519881759. Epub 2019 Nov 1. |
| 31654272 | Derived | Okai AF, Amezcua L, Berkovich RR, Chinea AR, Edwards KR, Steingo B, Walker A, Jacobs AK, Daizadeh N, Williams MJ; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). Neurol Ther. 2019 Dec;8(2):367-381. doi: 10.1007/s40120-019-00159-2. Epub 2019 Oct 25. |
| 31144568 | Derived | Arroyo R, Bury DP, Guo JD, Margolin DH, Melanson M, Daizadeh N, Cella D. Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis. Mult Scler. 2020 Jul;26(8):955-963. doi: 10.1177/1352458519849796. Epub 2019 May 30. |
| 30144037 | Derived | Li Z, Richards S, Surks HK, Jacobs A, Panzara MA. Clinical pharmacology of alemtuzumab, an anti-CD52 immunomodulator, in multiple sclerosis. Clin Exp Immunol. 2018 Dec;194(3):295-314. doi: 10.1111/cei.13208. Epub 2018 Oct 1. |
| 27590291 | Derived | Arnold DL, Fisher E, Brinar VV, Cohen JA, Coles AJ, Giovannoni G, Hartung HP, Havrdova E, Selmaj KW, Stojanovic M, Weiner HL, Lake SL, Margolin DH, Thomas DR, Panzara MA, Compston DA; CARE-MS I and CARE-MS II Investigators. Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon beta-1a in MS. Neurology. 2016 Oct 4;87(14):1464-1472. doi: 10.1212/WNL.0000000000003169. Epub 2016 Sep 2. |
| 25111080 | Derived | Grafals M, Smith B, Murakami N, Trabucco A, Hamill K, Marangos E, Gilligan H, Pomfret EA, Pomposelli JJ, Simpson MA, Azzi J, Najafian N, Riella LV. Immunophenotyping and efficacy of low dose ATG in non-sensitized kidney recipients undergoing early steroid withdrawal: a randomized pilot study. PLoS One. 2014 Aug 11;9(8):e104408. doi: 10.1371/journal.pone.0104408. eCollection 2014. |
Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
| FG002 | Alemtuzumab 24mg | Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study drug as per initial randomization.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Interferon Beta-1a | Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion. |
| BG001 | Alemtuzumab 12 mg | Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12. |
| BG002 | Alemtuzumab 24mg | Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Time Since First Relapse | Median | Full Range | years |
| |||||||||||||||
| Number of Relapse Episodes in the Preceding 2 Years | Number of participants with 1, 2 or greater than or equal to 3 relapses are reported. | Number | participants |
| |||||||||||||||
| Expanded Disability Status Scale (EDSS) Score | EDSS is an ordinal scale in half-point increments that quantifies disability in participants with multiple sclerosis (MS). It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Sustained Accumulation of Disability (SAD) | EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least the next 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported. | FAS population included all randomized participants who received at least 1 dose of study drug as per initial randomization. Analysis was not performed for Alemtuzumab 24 mg as recruitment to this arm was closed early to reduce overall sample size, duration of enrollment period, overall duration of study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2 years |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Annualized Relapse Rate | Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates. | FAS population. Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1. | Posted | Number | 95% Confidence Interval | relapses per participant per year | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Were Relapse Free at Year 2 | Participants were considered relapse free at Year 2 if they did not experience a relapse from the date of first study treatment to study completion at 24 months. Percentage of participants who were relapse free at Year 2, estimated using the KM method, was reported. | FAS population. Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1. | Posted | Number | 95% Confidence Interval | percentage of participants | Year 2 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2 | EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2. | FAS population. Here, number of participants analyzed was subset of FAS who had EDSS assessment at both Baseline and end-of-study (Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Year 2 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2 | MSFC is a multidimensional measure consisting of quantitative tests of ambulation (Timed 25-Foot Walk), manual dexterity (9-Hole Peg Test; 9HPT), and cognitive function (Paced Auditory Serial Addition Test; PASAT). The MSFC score was calculated as the mean of the Z-scores of the 3 components. A Z-score was calculated by subtracting the mean of the reference population from the test result, then dividing by the standard deviation of the reference population. Higher Z-scores reflected better neurological function and a positive change from Baseline indicates improvement. An increase in score indicated an improvement (Z-score range: -3 to +3). Acquisition of disability was measured by change from Baseline in MSFC score at Year 2. | FAS population. Here, number of participants analyzed signifies subset of FAS who had MSFC score assessment at Baseline; 'n' signifies participants who had MSFC score assessment at Baseline (for Baseline) and at both Baseline and Year 2 (for change at Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1. | Posted | Mean | Standard Deviation | Z-score | Baseline, Year 2 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2 | Percent change in MS lesion volume as measured by MRI-T2 scan was calculated from MRI-T2-weighted scans as the following: (lesion volume at 2 years - lesion volume at Baseline)*100/ (lesion volume at Baseline). | FAS population. Here, number of participants analyzed was subset of FAS who had assessment for T2 volume at both Baseline and end-of-study (Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1. | Posted | Mean | Standard Deviation | percent change | Baseline, Year 2 |
|
|
First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interferon Beta-1a | Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion. | 44 | 202 | 189 | 202 | ||
| EG001 | Alemtuzumab 12 mg | Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12. | 85 | 435 | 427 | 435 | ||
| EG002 | Alemtuzumab 24 mg | Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12. | 30 | 161 | 159 | 161 | ||
| EG003 | Alemtuzumab (Pooled) | Included all participants who received alemtuzumab 12 mg or 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg or 24 mg per day IV infusion on 3 consecutive days at Month 12. | 115 | 596 | 586 | 596 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Autoimmune thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Retinal pigment epitheliopathy | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Peptic ulcer perforation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sigmoiditis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abasia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Injection site abscess | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pasteurella infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vulval cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Intracranial hypotension | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Status migrainosus | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Drug dependence | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Automatic bladder | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vulvar dysplasia | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oropharyngeal blistering | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Female sterilisation | Surgical and medical procedures | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| CD4 lymphocytes decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| CD8 lymphocytes decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| T-lymphocyte count decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
Efficacy analysis was not performed for Alemtuzumab 24 mg as recruitment to this arm was closed early to reduce overall sample size, duration of enrollment period, overall duration of study.
PI can publish after sponsor published, after a defined period of time after study completion, and/or with written Sponsor approval. Generally PI gives sponsor a draft 60 days before publication. Sponsor can ask that confidential information can be removed, and can further defer publication upon notifying PI that it will file a patent application on inventions contained in the draft.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-us@sanofi.com |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| 2 Relapses |
|
| Greater than or equal to 3 Relapses |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| Participants |
|
|
|
|
|
|
|
|