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Multiple Sclerosis, Relapsing-RemittingPhase 3CARE-MS INCT00530348

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One

A Phase 3 study testing Alemtuzumab and Interferon beta-1a in people with Multiple Sclerosis, Relapsing-Remitting, run by Genzyme, a Sanofi Company at 101 sites in 16 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

The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous (SC) interferon beta-1a (Rebif®). Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Multiple Sclerosis, Relapsing-Remitting
What is being tested?
Alemtuzumab and Interferon beta-1a
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
581 participants
Where
101 sitesin 16 countries
Study dates
Aug 2007to Apr 2011
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 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Given written/signed informed consent
  • Age 18 to 50 years old (inclusive) as of the date the informed consent form (ICF) was signed
  • Diagnosis of MS per updated McDonald criteria, and cranial magnetic resonance imaging (MRI) scan demonstrating white matter lesions attributable to MS within 5 years of screening
  • Onset of MS symptoms (as determined by a neurologist, either at screening or retrospectively) within 5 years of the date the ICF was signed
  • Expanded Disability Status Scale (EDSS) score 0.0 to 3.0 (inclusive) at screening
  • Greater than or equal to (>=) 2 MS attacks (first episode or relapse) occurring in the 24 months prior to the date the ICF was signed, with >=1 attack in the 12 months prior to the date the ICF was signed, with objective neurological signs confirmed by a physician, nurse practitioner, or other Genzyme-approved health-care provider and the objective signs could be identified retrospectively

Who cannot join

  • Received prior therapy for MS other than corticosteroids, for example, alemtuzumab, interferons, intravenous immunoglobulin, glatiramer acetate, natalizumab, and mitoxantrone
  • Exposure to azathioprine, cladribine, cyclophosphamide, cyclosporine A, methotrexate, or any other immunosuppressive agent other than systemic corticosteroid treatment
  • Any progressive form of MS
  • History of malignancy (except basal skin cell carcinoma)
  • CD4 + , CD8 + count, B cell, or absolute neutrophil count less than (<) lower limit of normal (LLN) at screening
  • Known bleeding disorder (for example, dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, or clotting factor deficiency)
Show all 9Show fewer
  • Significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
  • Presence of anti-thyroid stimulating hormone (TSH) receptor (TSHR) antibodies (that is, above the LLN)
  • Active infection or at high risk for infection

Trial locations and contacts

101 sites in 16 countries.

101 sites in 16 countries

United States36 sites

  • University of New Mexico, Health Sciences Center, MS Specialty Clinic

    Albuquerque, New Mexico

  • Lehigh Valley Hospital Neurosciences and Pain Research

    Allentown, Pennsylvania

  • University of Michigan Health System

    Ann Arbor, Michigan

  • Carolinas Medical Center (CMC), Neurosciences & Spine Institute (NSSI)

    Charlotte, North Carolina

  • The Ohio State University Medical Center, Multiple Sclerosis Center

    Columbus, Ohio

  • North Central Neurology Associates, P.C.

    Cullman, Alabama

  • Wayne State University

    Detroit, Michigan

  • Advanced Neurosciences Research

    Fort Collins, Colorado

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana

  • Advanced Neurosciences Institute

    Franklin, Tennessee

  • Biomedical Research Alliance of NY, LLC

    Franklin, Tennessee

  • Baylor College of Medicine, Maxine Mesinger MS Clinic

    Houston, Texas

  • Idaho Falls Multiple Sclerosis Center, PLLC

    Idaho Falls, Idaho

  • University of Kansas Medical Center

    Kansas City, Kansas

  • Hope Neurology PC

    Knoxville, Tennessee

  • University of Nevada School of Medicine

    Las Vegas, Nevada

  • Empire Neurology

    Latham, New York

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire

  • MidAmerican Neuroscience Institute

    Lenexa, Kansas

  • Associates in Neurology, PSC

    Lexington, Kentucky

  • University of Louisville Research Foundation

    Louisville, Kentucky

  • Consultants in Neurology, Ltd.

    Northbrook, Illinois

  • MS Center of Oklahoma

    Oklahoma City, Oklahoma

  • Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C.

    Patchogue, New York

  • Barrow Neurological Institute, St. Joseph's Hospital & Medical Center

    Phoenix, Arizona

  • Neurological Associates

    Pompano Beach, Florida

  • University of Rochester Medical Center

    Rochester, New York

  • Central Texas Neurology

    Round Rock, Texas

  • Integra Clinical Research

    San Antonio, Texas

  • Neurology Center of San Antonio

    San Antonio, Texas

  • Mayo Clinic Arizona

    Scottsdale, Arizona

  • Louisiana State University Health Sciences Center

    Shreveport, Louisiana

  • Axiom Clinical Research of Florida

    Tampa, Florida

  • Northwest NeuroSpecialists, PLLC

    Tucson, Arizona

  • Oak Clinic for Multiple Sclerosis

    Uniontown, Ohio

  • UMass Memorial Medical Center

    Worcester, Massachusetts

Other trials in United States

Russia12 sites

  • Research Medical Complex "Your Health" Ltd

    Kazan'

  • Moscow City Hospital #11

    Moscow

  • Moscow State Medical Institution City Clinical Hospital #11

    Moscow

  • Scientific Neurology Center RAMS

    Moscow

  • Municipal City Hospital #33

    Nizhny Novgorod

  • Federal State Institution Siberian Rettitorial Medical Center under Federal Medical-Biological Agency of Russia

    Novosibirsk

  • City Clinical Hospital #2

    Pyatigorsk

  • Institute of Human Brain RAS

    Saint Petersburg

  • Nikolaevskaya Hospital

    Saint Petersburg

  • St. Petersburg Pavlov State Medical University

    Saint Petersburg

  • Samara Regional Clinical Hospital n.a. Kalinin

    Samara

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

    Ufa

Other trials in Russia

Australia9 sites

  • The Wesley Research Institute

    Auchenflower, Queensland, 4066

  • Concord Repatriation General Hospital

    Concord

  • St Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Austin Health

    Heidelberg, Victoria, 3084

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Royal Melbourne Hospital, Department of Neurology, Ward 4 East

    Parkville, Victoria, 3050

  • Griffith University School of Medicine

    Southport, Queensland

  • Westmead Hospital

    Westmead

  • The Queen Elizabeth Hospital

    Woodville South, South Australia

Other trials in Australia

Germany6 sites

  • Judisches Krankenhaus Berlin

    Berlin

  • Universitätsklinik Carl Gustav Carus Dresden

    Dresden

  • Klinikum der Goethe Universität Frankfurt

    Frankfurt

  • Medizinische Hochschule Hannover

    Hanover

  • Oberhavelkliniken Hennigsdorf

    Hennigsdorf

  • Asklepios Klinikum Brandenburg

    Teupitz

Other trials in Germany

Canada5 sites

  • University of Calgary and Foothills Medical Cenre

    Calgary, Alberta

  • Clinique Nuero-outaouais

    Gatineau, Quebec

  • Clinique Neuro rive-sud, Recherche Sepmus, Inc.

    Greenfield Park, Quebec

  • The Ottawa Hospital, General Campus

    Ottawa, Ontario

  • UBC Hospital

    Vancouver, British Columbia

Other trials in Canada

Croatia5 sites

  • Clinical Hospital Centre Rijeka

    Rijeka

  • General Hospital Varazdin

    Varaždin

  • Clinical Hospital Centre "Sestre Milosrdnice"

    Zagreb

  • Clinical Hospital Centre Zagreb

    Zagreb

  • General Hospital "Sveti Duh"

    Zagreb

Other trials in Croatia

Serbia5 sites

  • Clinical Centre Serbia, Institute for Neurology

    Belgrade

  • Military Medical Academy

    Belgrade

  • Clinical centre Kragujevac

    Kragujevac

  • Clinical Center Nis, Clinic for neurology

    Niš

  • Clinical Centre of Vojvodina, Clinic for neurology

    Novi Sad

Other trials in Serbia

Ukraine5 sites

  • Chernihiv Regional Hospital

    Chernihiv

  • Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine, Department of Neuroinfection and Multiple Sclerosis

    Kharkiv

  • Hospoital of the Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Department

    Kyiv

  • Kyiv Municipal Clinical Hospital #4

    Kyiv

  • Danylo Halytsky Lviv National Medical University

    Lviv

Other trials in Ukraine

Poland4 sites

  • Clinical Neurology Centre Sp. z o.o. (Ltd)

    Cracow

  • Independent Public Healthcare Facility, Norbert Barlicki University Hospital No. 1 of the Medical University of Lodz

    Lodz

  • Independent Public Teaching Hospital No. 4 in Lublin

    Lublin

  • Heliodor Swiecicki Teaching Hospital of the Poznan University of Medical Sciences

    Poznan

Other trials in Poland

United Kingdom4 sites

  • Department Of Neurosciences, Addenbrookes Hospital

    Cambridge, England

  • University Hospital of Wales

    Cardiff, Wales

  • Centre for Neuroscience & Trauma, Blizard Institute of Cell and Molecular Science, Barts and The London School of Medicine and Dentistry

    London, England

  • Royal Hallamshire Hospital

    Sheffield

Other trials in United Kingdom

Brazil3 sites

  • Hospital Sao Lucas PUC-RS

    Porto Alegre, Rio Grande do Sul

  • Hospital da Restauracao, Av Governador Agamenon Magalhaes

    Recife, Pernambuco

  • Hospital de Clínicas USP

    São Paulo, São Paulo

Other trials in Brazil

Czechia2 sites

  • Department of Neurology, 1st Faculty of Medicine and General Teaching Hospital

    Prague

  • Krajska zdravotni a.s., Hospital Teplice

    Teplice

Other trials in Czechia

Mexico2 sites

  • Hospital Angeles del Pedregal, Camino de Santa Teresa

    Mexico City

  • Hospital Medica Sur CIF-BIOTEC

    Mexico City

Other trials in Mexico

Argentina1 site

  • DIABAID

    Buenos Aires

Other trials in Argentina

France1 site

  • Hopital Purpan

    Toulouse

Other trials in France

Sweden1 site

  • Sahlgrenska University Hospital

    Gothenburg

Other trials in Sweden

About this study

Official title: A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis

The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had not previously received MS disease-modifying therapies. Participants had monthly laboratory tests and comprehensive testing every 3 months.

Read the detailed description

Every participant had received active treatment; there was no placebo. Participants who qualified were randomly assigned to treatment with either alemtuzumab or SC interferon beta-1a at a 2:1 ratio (that is, 2 given 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 CAMMS03409 (NCT00930553) an extension study for safety and efficacy assessments. Participants who received interferon beta-1a and completed 2 years on study might be eligible to receive alemtuzumab on the extension study.

Being tested
Alemtuzumab, Interferon beta-1a
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

    Also called Lemtrada

    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.

  • Interferon beta-1aBiological

    Also called Rebif®

    Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.

Study groups in NCT00530348
Study groupRoleWhat they receive
AlemtuzumabExperimentalNot described
Receives: Biological: Alemtuzumab
Interferon Beta-1aActive comparatorNot described
Receives: Biological: Interferon beta-1a

What is being measured

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

  1. Percentage of Participants With Sustained Accumulation of Disability (SAD)

    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: 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 next 2 scheduled assessments, that is, 6 consecutive months. 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.

    Measured: Up to 2 years

  2. 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.

    Measured: Up to 2 years

Secondary outcomes (4)

  1. 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.

    Measured: Year 2

  2. Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2

    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). Change was calculated by subtracting Baseline value from value at Year 2.

    Measured: Baseline, Year 2

  3. 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.

    Measured: Baseline, Year 2

  4. 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).

    Measured: Baseline, Year 2

Timeline

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

  1. First posted17 Sep 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionApr 2011
  4. Study completionApr 2011

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
581 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00530348
Sponsor's protocol ID
CAMMS323
Other IDs
ISRCTN21534255, ACTRN12608000435381, CARE-MS I, 2007-001161-14
Acronym
CARE-MS I
Status last verified
Nov 2014
First submitted
13 Sep 2007
Last updated
24 Nov 2014
Data monitoring committee
Yes

Publications

  • 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

  • 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

  • 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.

    PubMed 37272540

  • 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

  • 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

  • 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

  • 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.

    PubMed 31654272

  • 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.

    PubMed 30144037

  • Havrdova E, Arnold DL, Cohen JA, Hartung HP, Fox EJ, Giovannoni G, Schippling S, Selmaj KW, Traboulsee A, Compston DAS, Margolin DH, Thangavelu K, Rodriguez CE, Jody D, Hogan RJ, Xenopoulos P, Panzara MA, Coles AJ; CARE-MS I and CAMMS03409 Investigators. Alemtuzumab CARE-MS I 5-year follow-up: Durable efficacy in the absence of continuous MS therapy. Neurology. 2017 Sep 12;89(11):1107-1116. doi: 10.1212/WNL.0000000000004313. Epub 2017 Aug 23.

    PubMed 28835401

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alemtuzumab and Interferon beta-1a in people with Multiple Sclerosis, Relapsing-Remitting, run by Genzyme, a Sanofi Company at 101 sites in 16 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 6 inclusion and 9 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 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United States, Russia, Australia, Germany, Canada and 11 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 24 Nov 2014). 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?

Percentage of Participants With Sustained Accumulation of Disability (SAD) (time frame: Up to 2 years). The study lists 2 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 NCT00530348, which also lists 16 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 24 Nov 2014.

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