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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00530348




Registration number
NCT00530348
Ethics application status
Date submitted
13/09/2007
Date registered
17/09/2007
Date last updated
24/11/2014

Titles & IDs
Public title
Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One
Scientific 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
Secondary ID [1] 0 0
ISRCTN21534255
Secondary ID [2] 0 0
CAMMS323
Universal Trial Number (UTN)
Trial acronym
CARE-MS I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis, Relapsing-Remitting 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Alemtuzumab
Other interventions - Interferon beta-1a

Experimental: Alemtuzumab -

Active Comparator: Interferon Beta-1a -


Other interventions: Alemtuzumab
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.

Other interventions: Interferon beta-1a
Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Sustained Accumulation of Disability (SAD)
Timepoint [1] 0 0
Up to 2 years
Primary outcome [2] 0 0
Annualized Relapse Rate
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Percentage of Participants Who Were Relapse Free at Year 2
Timepoint [1] 0 0
Year 2
Secondary outcome [2] 0 0
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2
Timepoint [2] 0 0
Baseline, Year 2
Secondary outcome [3] 0 0
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2
Timepoint [3] 0 0
Baseline, Year 2
Secondary outcome [4] 0 0
Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2
Timepoint [4] 0 0
Baseline, Year 2

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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)

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2011
Sample size
Target
Accrual to date
Final
581
Recruitment in Australia
Recruitment state(s)
QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
The Wesley Research Institute - Auchenflower
Recruitment hospital [2] 0 0
Griffith University School of Medicine - Southport
Recruitment hospital [3] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [4] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [5] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [6] 0 0
Austin Health - Heidelberg
Recruitment hospital [7] 0 0
Royal Melbourne Hospital, Department of Neurology, Ward 4 East - Parkville
Recruitment hospital [8] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [9] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
- Southport
Recruitment postcode(s) [3] 0 0
- Woodville South
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
- Concord
Recruitment postcode(s) [9] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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Colorado
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Florida
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Idaho
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United States of America
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Illinois
Country [7] 0 0
United States of America
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Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
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Louisiana
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Massachusetts
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Michigan
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Nevada
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New Hampshire
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Tennessee
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United States of America
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Texas
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Argentina
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Buenos Aires
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Brazil
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Pernambuco
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Brazil
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RS
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Brazil
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SP
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Croatia
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Rijeka
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Croatia
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Varazdin
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Croatia
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Zagreb
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Czech Republic
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Praha 2
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Czech Republic
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Teplice
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France
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Toulouse
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Germany
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Berlin
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Germany
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Dresden
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Frankfurt
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Hannover
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Germany
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Hennigsdorf
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Germany
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Teupitz
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Mexico
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Mexico City
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Poland
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Cracow
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Lodz
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Poland
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Lublin
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Poland
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Poznan
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Pyatigorsk
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Samara
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Russian Federation
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St. Petersburg
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Russian Federation
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Ufa
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Serbia
State/province [56] 0 0
Belgrade
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Serbia
State/province [57] 0 0
Kragujevac
Country [58] 0 0
Serbia
State/province [58] 0 0
Nis
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Serbia
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Novi Sad
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Sweden
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Goteborg
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Ukraine
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Chernihiv
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
Country [64] 0 0
Ukraine
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Lviv
Country [65] 0 0
United Kingdom
State/province [65] 0 0
England
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Wales
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genzyme, a Sanofi Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bayer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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®). 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00530348
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Genzyme, a Sanofi Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries