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Multiple Sclerosis, Relapsing-RemittingPhase 3NCT00930553

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

A Phase 3 study testing alemtuzumab in people with Multiple Sclerosis, Relapsing-Remitting, run by Genzyme, a Sanofi Company at 176 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This open-label, rater-blinded extension study enrolled participants who had 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Multiple Sclerosis, Relapsing-Remitting
What is being tested?
alemtuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,314 participants
Where
176 sitesin 23 countries
Study dates
Aug 2009to Feb 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 1.Received alemtuzumab in CAMMS323 or CAMMS324, completed the 2-year study period, and had 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 had 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 meant that participants 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 were not eligible for inclusion in the Extension Study. Participants who enrolled in CAMMS324 after participation in CAMMS223 must meet criteria 1 or 2 to be eligible for inclusion in the Extension Study.

Who cannot join

  • Any alemtuzumab participant from CAMMS223, CAMMS323, or CAMMS324 who had received alemtuzumab off-label (ie, outside of one of the prior Genzyme-sponsored studies), or was participating in any other investigational study, unless approved by Genzyme. In addition, these participants must be screened for disqualifying safety concerns before receiving alemtuzumab retreatment.
  • Any Rebif® participants from CAMMS223, CAMMS323, or CAMMS324 who met any of the following criteria. In addition, these participants must be screened for disqualifying safety concerns before receiving alemtuzumab treatment. a) Did not wish to receive alemtuzumab; b) Ongoing participation in any other investigational study, unless approved by Genzyme; c) Had 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 participants only).

Trial locations and contacts

176 sites in 23 countries.

176 sites in 23 countries

United States69 sites

  • University of New Mexico, Dept. of Neurology

    Albuquerque, New Mexico

  • Lehigh Valley Hospital Neurosciences and Pain Research

    Allentown, Pennsylvania

  • University of Michigan Medical School

    Ann Arbor, Michigan

  • Emory University Department of Neurology

    Atlanta, Georgia

  • Shepherd Center Multiple Sclerosis Institute

    Atlanta, Georgia

  • University of Colorado Health Science Center - Aurora

    Aurora, Colorado

  • University of Maryland, Maryland Center for MS

    Baltimore, Maryland

  • East Bay Physicians Medical Group/ Sutter East Bay Medical Foundation

    Berkeley, California

  • The MS Center at St. Elizabeth's

    Boston, Massachusetts

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina

  • University of Chicago Medical Center

    Chicago, Illinois

  • Cleveland Clinic Foundation

    Cleveland, Ohio

  • Michigan Neurology Association

    Clinton, Michigan

  • Neurology Clinic PC

    Cordova, Tennessee

  • North Central Neurology Associates, P.C.

    Cullman, Alabama

  • Iowa Health Physicians

    Des Moines, Iowa

  • Ruan Neurology Clinic and Clinical Research Center, Mercy Medical Center

    Des Moines, Iowa

  • Wayne State University, The School of Medicine, Department of Neurology

    Detroit, Michigan

  • Advanced Neurology of Colorado

    Fort Collins, Colorado

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana

  • Advanced Neurosciences Institute

    Franklin, Tennessee

  • Spectrum Health Medical Group, Neurology/Michigan Medical P.C., West Michigan MS Clinic

    Grand Rapids, Michigan

  • Baylor College of Medicine, Maxine Mesinger MS Clinic

    Houston, Texas

  • Indiana University Multiple Sclerosis Center

    Indianapolis, Indiana

  • University of Florida Neuroscience Institute

    Jacksonville, Florida

  • University of Kansas Medical Center, Department of Neurology

    Kansas City, Kansas

  • Saint Luke's Brain & Stroke Institute

    Kansas City, Missouri

  • Hope Neurology

    Knoxville, Tennessee

  • Neurology Center North Orange County

    La Habra, California

  • Empire Neurology P.C.

    Latham, New York

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire

  • MidAmerica Neuroscience Institute

    Lenexa, Kansas

  • Associates in Neurology, P.S.C.

    Lexington, Kentucky

  • University of Southern California Keck School of Medicine/University of Southern California LAC & USC Medical Center

    Los Angeles, California

  • Kentucky Neuroscience Research

    Louisville, Kentucky

  • Neurology Associates, P.A.

    Maitland, Florida

  • Winthrop University Hospital Multiple Sclerosis Treatment Center

    Mineola, New York

  • Vanderbilt University Medical Center

    Nashville, Tennessee

  • Yale MS Research Center

    New Haven, Connecticut

  • MS Care Center at NYUMC and HJD

    New York, New York

  • The Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai

    New York, New York

  • Consultants in Neurology, LTD

    Northbrook, Illinois

  • OMRF Multiple Sclerosis Center of Excellence

    Oklahoma City, Oklahoma

  • Neuro-Therapeutics, Inc.

    Pasadena, California

  • South Shore Neurologic Associates, P.C.

    Patchogue, New York

  • HOPE Research Institute

    Phoenix, Arizona

  • St. Joseph's Hospital and Medical Center Barrow Neurology Clinics - Barrow Neurological Institute

    Phoenix, Arizona

  • Neurological Associates

    Pompano Beach, Florida

  • Rhode Island Hospital MS Center - The Neurology Foundation, Inc

    Providence, Rhode Island

  • Renown Institute for Neurosciences

    Reno, Nevada

  • Rochester Multiple Sclerosis Center

    Rochester, New York

  • Central Texas Neurology Consultants

    Round Rock, Texas

  • Integra Clinical Research

    San Antonio, Texas

  • Neurology Center of San Antonio

    San Antonio, Texas

  • Negroski, Stein, Sutherland and Hanes Neurology

    Sarasota, Florida

  • Mayo Clinic Arizona (Scottsdale)

    Scottsdale, Arizona

  • Swedish Medical MS Center

    Seattle, Washington

  • Stanford University Medical Center

    Stanford, California

  • SUNY Upstate Medical University, Department of Neurology

    Syracuse, New York

  • Axiom Clinical Research of Florida

    Tampa, Florida

  • University of South Florida College of Medicine

    Tampa, Florida

  • MS Center at Holy Name Hospital

    Teaneck, New Jersey

  • Northern Michigan Neurology

    Traverse City, Michigan

  • Northwest NeuroSpecialists, PLLC

    Tucson, Arizona

  • Oak Clinic for Multiple Sclerosis

    Uniontown, Ohio

  • MS Center of Greater Washington

    Vienna, Virginia

  • The George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia

  • Wake Forest University Health Science Department of Neurology

    Winston-Salem, North Carolina

  • UMass Memorial Medical Center

    Worcester, Massachusetts

Other trials in United States

Russia13 sites

  • Research Medical Complex "Your Health" Ltd

    Kazan'

  • Moscow State Public Medical Institution Clinical Hospital #11, Neurology Department

    Moscow

  • Neurology Research Center under the Russian Academy of Medical Sciences

    Moscow

  • Russian State Medical University, Department of Neurology and Neurosurgery

    Moscow

  • Municipal Treatment and Prevention Institution, City Hospital #33

    Nizhny Novgorod

  • Federal State Public Medical Institution: Siberian District Medical Center under the Federal Agency

    Novosibirsk

  • Municipal Public Medical Institution: City Hospital #2 of Pyatigorsk, Neurology Department

    Pyatigorsk

  • Institute of Human Brain RAS, Laboratory of Neuroimmunology

    Saint Petersburg

  • St Petersburg State Pavlov Medical University, Dept of Neurology and Neurosurgery with a Hospital

    Saint Petersburg

  • St. Petersburg General Hospital #2, Neurology Department #2

    Saint Petersburg

  • St. Petersburg State Public Medical Institution: Nikolayevskaya Hospital

    Saint Petersburg

  • Samara Regional Clinical Hospital n.a. Kalinin

    Samara

  • State Public Medical Institution: Republican Clinical Hospital n.a. G.G. Kuvatov

    Ufa

Other trials in Russia

Germany12 sites

  • Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn

    Bonn, DE

  • Universitätsklinik Carl Gustav Carus Dresden

    Dresden

  • Klinikum der JW Goethe Universität

    Frankfurt am Main

  • Asklepios Klinik Barmbek

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

  • Oberhavel Klinicum GmbH - Krankenhaus Hennigsdorf

    Hennigsdorf

  • Klinikum Ingolstadt

    Ingolstadt

  • Jüdisches Krankenhaus Berlin

    Mitte

  • Klinikum rechts der Isar

    München

  • Medizinische Fakultät der Universität Rostock,Zentrum für Nervenheilkunde

    Rostock

  • Universitätsklinikum Ulm, Klinik für Neurologie im RKU

    Ulm

  • Fachkrankenhaus Hubertusburg GmbH, Klinik für Neurologie und Neurologische Intensivmedizin

    Wermsdorf

Other trials in Germany

Australia11 sites

  • The Wesley Research Institute

    Auchenflower QLD

  • Concord Repatriation General Hospital

    Concord, New South Wales

  • St. Vincent's Hospital

    Fitzroy, Victoria

  • Austin Health

    Heidelberg, Victoria

  • Royal Hobart Hospital

    Hobart, Tasmania

  • Southern Neurology

    Kogarah, New South Wales

  • Liverpool Hospital

    Liverpool, New South Wales

  • Royal Melbourne Hospital

    Parkville, Victoria

  • Gold Coast Hospital

    Southport, Queensland

  • Westmead Hospital

    Westmead, New South Wales

  • The Queen Elizabeth Hospital

    Woodville, SA

Other trials in Australia

Canada8 sites

  • University of Calgary, Department of Neurology

    Calgary, Alberta

  • Clinique Neuro-Outaouais

    Gatineau, Quebec

  • Recherche Sepmus, Inc.

    Greenfield Park, Quebec

  • Kingston General Hospital MS Clinic

    Kingston, Ontario

  • London Health Sciences Centre - University Hospital

    London, on

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec

  • The Ottawa Hospital - MS Research

    Ottawa, Ontario

  • University of British Columbia

    Vancouver, BC

Other trials in Canada

Croatia6 sites

  • Clinical Hospital Osijek

    Osijek

  • Clinical Hospital Centre Rijeka

    Rijeka

  • General Hospital Varazdin, Department for Neurology

    Varaždin

  • Clinical Hospital Centre "Sestre Milosrdnice"

    Zagreb

  • Clinical Hospital Centre Zagreb

    Zagreb

  • Clinical Hospital Sveti Duh

    Zagreb

Other trials in Croatia

United Kingdom6 sites

  • Frenchay Hospital

    Bristol

  • Addenbrookes Hospital

    Cambridge

  • University Hospital of Wales, Dept of Neurology

    Cardiff

  • Royal London Hospital

    London

  • Salford Royal NHS Foundation Trust

    Salford

  • Royal Hallamshire Hospital

    Sheffield

Other trials in United Kingdom

France5 sites

  • Hôpital Général

    Dijon

  • Groupe Hospitalier Pitié-Salpêtrière, Fédération de Maladies du System Nerveux Central

    Paris

  • CHU Pontchaillou

    Rennes

  • Hôpital Civil

    Strasbourg

  • CHU de Toulouse, Hôpital Purpan

    Toulouse

Other trials in France

Poland5 sites

  • Centrum Neurologii Klinicznej Sp. Zo.o.

    Krakow

  • Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny Nr1 im. Norberta Barlickiego

    Lodz

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin

  • Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Med. im. Karola Marcinkowskiego w Poznaniu

    Poznan

  • Institute of Psychiatry and Neurology/Instytut Psychiatrii i Neurologii

    Warsaw

Other trials in Poland

Serbia5 sites

  • Clinical Centre Serbia, Institute of Neurology,Dr.Subotica 6,Belgrade

    Belgrade

  • Military Medical Academy, Institute of Neurology

    Belgrade

  • Clinical Centre Kragujevac, Clinic of Neurology

    Kragujevac

  • Clinical Centre Nis, Clinic of Neurology

    Niš

  • Clinical Centre Vojvodina

    Novi Sad

Other trials in Serbia

Brazil4 sites

  • Hospital Mae de Deus

    Porto Alegre

  • Hospital da Restauração, Neurology department

    Recife, PE

  • Irmandade da Santa Casa de Misericórdio de São Paulo, Neurology department

    São Paulo, SP

  • Hospital das Clínicas da Faculdade de Medicina da USP, Neurology department

    São Paulo,SP

Other trials in Brazil

Czechia4 sites

  • St. Anne's University Hospital Brno

    Brno

  • University Hospital Hradec Králové

    Hradec Králové

  • General Hospital, 128 21 Praha 2

    Prague

  • Hospital Teplice, Neurology Department, MS centrum

    Teplice

Other trials in Czechia

Italy4 sites

  • Università di Cagliari

    Cagliari

  • Ospedale S. Antonio Abate di Gallarate

    Gallarate (Varese)

  • Ospedale S. Luigi Gonzaga

    Orbassano (TO)

  • Universita Degli Studi di Roma "La Sapienza"

    Roma

Other trials in Italy

Spain4 sites

  • Hospital Universitario Vall d' Hebron

    Barcelona

  • Hospital Clínico Universitario San Carlos

    Madrid

  • Hospital Carlos Haya, Neurology Service

    Málaga

  • Hospital Virgen Macarena

    Seville

Other trials in Spain

Ukraine4 sites

  • Institute of Neurology, Psychiatry and Narcology under the AMS of Ukraine, Dep of Neuroinfection& MS

    Kharkiv

  • Kiev Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System

    Kiev

  • Hospital of Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Dept.

    Kiev-21

  • Lviv National Medical University n.a. Danylo Galytsky, Department of Neurology

    Lviv

Other trials in Ukraine

Belgium3 sites

  • Cliniques Universitaires Saint-luc

    Brussels

  • CHU Ourthe Amblève

    Esneux

  • University Hospital Leuven, Campus Gasthuisberg

    Leuven

Other trials in Belgium

Israel3 sites

  • Hadassah Medical Center Ein Karem

    Ein Karem, Jerusalem

  • Sheba Medical Center

    Ramat Gan

  • Sourasky Tel Aviv Medical Center

    Tel Aviv

Other trials in Israel

Denmark2 sites

  • Aarhus Sygehus

    Århus C

  • Rigshospitalet Department of Neurology

    Copenhagen

Other trials in Denmark

Mexico2 sites

  • Unidad de Investigación en Salud

    Chihuahua, CHH

  • Medica Sur

    Mexico City, DFE

Other trials in Mexico

Netherlands2 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

  • Orbis Medisch Concern

    Sittard-Geleen

Other trials in Netherlands

Sweden2 sites

  • SU/Östra sjukhuset

    Gothenburg

  • Norrlands Universitets sjukhus

    Umeå

Other trials in Sweden

Argentina1 site

  • DIABAID

    Buenos Aires

Other trials in Argentina

Austria1 site

  • AKH Wien-Universitätskliniken für Neurologie

    Vienna

Other trials in Austria

About this study

This open-label, rater-blinded extension study enrolled participants who had 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 were:

  1. To examine the long term safety and efficacy of alemtuzumab treatment in participants 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 participants who received Rebif® (interferon beta-1a) as their study treatment in one of the prior studies.
  3. To determine the safety and efficacy of additional "as needed" alemtuzumab treatment courses. This applied both to participants who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.
Read the detailed description

Alemtuzumab treatment was on a fixed schedule of two treatment courses a year apart for participants 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 Multiple Sclerosis [MS] activity) for participants who had already completed a fixed schedule of treatment with alemtuzumab in one of the prior Genzyme-sponsored studies. There was no comparison treatment in this study. All participants were required to return to their study site every 3 months for neurologic and other assessments. In addition, safety-related laboratory tests and surveys were performed at least monthly. Participation in the extension study was at least 48 months from enrollment. Study duration could be extended to allow participants to remain in the study until a follow-up study was available in their country or through month 60 (month 72 in USA), whichever occurred first.

Being tested
alemtuzumab
Keywords
Multiple Sclerosis
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alemtuzumabBiological

    Alemtuzumab 12 mg/day IV infusion on 5 consecutive days if the participants had no prior alemtuzumab exposure (ie, first treatment course). All subsequent treatment courses were for 3 days only.

Study groups in NCT00930553
Study groupRoleWhat they receive
Previously treated with alemtuzumabExperimentalAlemtuzumab 12 mg per day administered through IV, once a day for 3 consecutive days (participants might receive additional cycles of alemtuzumab upon documented evidence of resumed disease activity, but not within same 12-month period)
Receives: Biological: alemtuzumab
Previously treated with interferon beta-1a (Rebif®)ExperimentalAlemtuzumab 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. Participants might 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.
Receives: Biological: alemtuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized Relapse Rate (ARR)

    Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis (MS) that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation.

    Measured: Year 3, 4, 5, 6 from the Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively)

  2. Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab

    Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through repeated negative binomial regression with robust variance estimation and covariate adjustment for geographic region. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.

    Measured: Baseline (Year 0 of initial studies) up to Year 4

  3. Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment

    Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation without covariate adjustment.

    Measured: Year 1 prior to retreatment, Year 1, 2, 3 after retreatment

  4. Number of Participants With Sustained Accumulation of Disability (SAD)

    SAD: defined as an increase of at least 1.5 points in Expanded Disability Status Scale (EDSS) score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD was estimated by Kaplan-Meier method and reported in this outcome measure. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "alemtuzumab treatment CAMMS323 extension" group and "alemtuzumab Treatment CAMMS324 Extension" group, respectively.

    Measured: Baseline (Year 0) up to Year 6

  5. Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison

    SAD: defined as an increase of at least 1.5 points in EDSS score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD over 2 years before and 2 years after alemtuzumab treatment were estimated by Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.

    Measured: Baseline (Year 0 of initial studies) up to Year 4

Secondary outcomes (20)

  1. Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6

    SRD was defined as a ≥1 point decrease in EDSS score lasting >= 6 months. SRD is only applicable to participants with a baseline EDSS score of >= 2.0. EDSS is an ordinal scale in half-point increments that quantifies 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 ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 6 was estimated using Kaplan-Meier method and reported in this outcome measure.

    Measured: Baseline (Year 0) up to Year 6

  2. Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study

    SRD was defined as a >=1 point decrease in EDSS score lasting >=6 months. SRD is only applicable to participants with a baseline EDSS score of ≥2.0. EDSS is an ordinal scale in half-point increments that quantifies 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 ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 2 of CAMMS03409 was estimated using Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.

    Measured: Extension study (CAMMS03409) baseline up to Extension Year 2

  3. Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6

    EDSS is an ordinal scale in half-point increments that quantifies disability in participants with 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), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 [NCT00530348] or CAMMS324 [NCT00548405]) value from EDSS scores at specified time points.

    Measured: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6

  4. Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison

    EDSS is an ordinal scale in half-point increments that quantifies disability in participants with 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), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 or CAMMS324 for pre alemtuzumab period or CAMMS03409 baseline for post alemtuzumab period) value, from EDSS scores at specified time points. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting groups. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "CAMMS323 participants" and "CAMMS324 participants" respectively.

    Measured: Baseline (Year 0 of initial studies) up to Year 4

  5. Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment

    EDSS is an ordinal scale in half-point increments that quantifies disability in participants with 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), where higher scores indicate worse neurological function. Change was calculated by subtracting retreatment baseline (annual visit prior to the retreatment start date) value from EDSS scores at specified time points.

    Measured: Retreatment baseline, Year 1, 2 and 3 after retreatment baseline

  6. Percentage of Participants Without New or Enlarging Magnetic Resonance Imaging (MRI)-T2-Hypertense Lesion Activity

    Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually.

    Measured: Year 3, 4, 5 and 6

  7. Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Treatment

    Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.

    Measured: Baseline (Year 0 of initial studies) up to Year 4

  8. Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Retreatment

    Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. Retreatment baseline was the annual visit prior to the retreatment start date.

    Measured: Retreatment Baseline, Year 1, 2 and 3 after retreatment

  9. Percentage Change From Baseline in MRI-T2-Hypertense Lesion Volumes at Year 3, 4, 5, 6

    Lesion volume was quantitatively assessed by hyperintensity on T2-weighted MRI scans.

    Measured: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6

  10. Percentage of Participants Without New Gadolinium-enhancing MRI Lesion Activity

    Analysis of new gadolinium-enhancing lesions that appear on MRI scans performed annually. Baseline was the prior annual visit.

    Measured: Year 3, 4, 5 and 6

  11. Percent Change From Baseline in Brain Parenchymal Fractions (BPF) at Year 3, 4, 5 and 6

    Brain parenchymal fraction (calculated as the ratio of brain parenchymal volume to total intradural volume), is a sensitive indicator of brain atrophy.

    Measured: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6

  12. Percentage of Relapse Free Participants

    Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability.

    Measured: Year 3, 4, 5 and 6

  13. Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey at Year 3, 4, 5 and 6

    SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of first four health aspects (1 - 4) were aggregated to derive the PCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.

    Measured: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "alemtuzumab treatment CAMMS323 extension group", "alemtuzumab Treatment CAMMS324 Extension" group, respectively),Year 3, 4, 5 and 6

  14. Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey Before and After Alemtuzumab Treatment: 2 Year Comparison

    SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of first four health aspects (1 - 4) were aggregated to derive the PCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "CAMMS323" and "CAMMS324" participants, respectively.

    Measured: Baseline (Year 0 of initial studies) up to Year 4

  15. Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) at Year 3, 4, 5, and 6

    SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of last four health aspects (5 - 8) were aggregated to derive the MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.

    Measured: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6

  16. Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) Before and After Alemtuzumab Treatment: 2 Year Comparison

    SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of last four health aspects (5 - 8) were aggregated to derive the MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "CAMMS323" and "CAMMS324" participants, respectively.

    Measured: Baseline (Year 0 of initial studies) up to Year 4

  17. Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score at Year 3, 4, 5 and 6

    FAMS is a widely accepted, MS-specific, quality of life questionnaire. It comprised of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Participants provided their response based on the recall of past week. Each item was rated on a 5-point scale ranges from 0 (poor) to 4 (best), where higher scores indicated higher/better quality of life. Scores from 44 calculable items were summed to provide FAMS total score. FAMS total score ranges from 0 (poor) to 176 (best), where higher scores indicated higher/better quality of life.

    Measured: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6

  18. Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score Before and After Alemtuzumab Treatment: 2 Year Comparison

    FAMS is a widely accepted, MS-specific, quality of life questionnaire. It comprised of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Participants provided their response based on the recall of past week. Each item was rated on a 5-point scale ranges from 0 (poor) to 4 (best), where higher scores indicated higher/better quality of life. Scores from 44 calculable items were summed to provide FAMS total score. FAMS total score ranges from 0 (poor) to 176 (best), where higher scores indicated higher/better quality of life. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.

    Measured: Baseline (Year 0 of initial studies) up to Year 4

  19. Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score at Year 3, 4, 5 and 6

    EQ-5D is a standardized instrument for measuring health status consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). The EQ-5D VAS range is from 0-100, higher scores indicate a better health state and a positive change indicates improvement.

    Measured: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6

  20. Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score Before and After Alemtuzumab Treatment: 2 Year Comparison

    EQ-5D is a standardized instrument for measuring health status consisting of EQ-5D descriptive system and VAS. The EQ-5D VAS range is from 0-100, higher scores indicate a better health state and a positive change indicates improvement. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.

    Measured: Baseline (Year 0 of initial studies) up to Year 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00930553
Sponsor's protocol ID
CAMMS03409
Other IDs
2009-010788-18, LTE12824, 2009
Status last verified
May 2017
First submitted
26 Jun 2009
Last updated
15 May 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18946064

  • Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Fisher E, Brinar VV, Giovannoni G, Stojanovic M, Ertik BI, Lake SL, Margolin DH, Panzara MA, Compston DA; CARE-MS I investigators. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1819-28. doi: 10.1016/S0140-6736(12)61769-3. Epub 2012 Nov 1.

    PubMed 23122652

  • 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.

    PubMed 23122650

  • 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.

    PubMed 39935588

  • 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.

    PubMed 37745914

  • 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.

    PubMed 36619856

  • 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.

    PubMed 34882037

  • Kuhle J, Daizadeh N, Benkert P, Maceski A, Barro C, Michalak Z, Sormani MP, Godin J, Shankara S, Samad TA, Jacobs A, Chung L, Rӧsch N, Kaiser C, Mitchell CP, Leppert D, Havari E, Kappos L. Sustained reduction of serum neurofilament light chain over 7 years by alemtuzumab in early relapsing-remitting MS. Mult Scler. 2022 Apr;28(4):573-582. doi: 10.1177/13524585211032348. Epub 2021 Aug 11.

    PubMed 34378446

  • 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.

    PubMed 34035833

  • Bass AD, Arroyo R, Boster AL, Boyko AN, Eichau S, Ionete C, Limmroth V, Navas C, Pelletier D, Pozzilli C, Ravenscroft J, Sousa L, Tintore M, Uitdehaag BMJ, Baker DP, Daizadeh N, Choudhry Z, Rog D; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years. Mult Scler Relat Disord. 2021 Apr;49:102717. doi: 10.1016/j.msard.2020.102717. Epub 2020 Dec 24.

    PubMed 33476880

  • 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.

    PubMed 33414927

  • 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.

    PubMed 32710396

  • 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.

    PubMed 32539719

  • 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.

    PubMed 31762387

  • 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.

    PubMed 31675266

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing alemtuzumab in people with Multiple Sclerosis, Relapsing-Remitting, run by Genzyme, a Sanofi Company at 176 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in United States, Russia, Germany, Australia, Canada and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized Relapse Rate (ARR) (time frame: Year 3, 4, 5, 6 from the Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00930553, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.

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