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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/NCT00548405
Registration number
NCT00548405
Ethics application status
Date submitted
22/10/2007
Date registered
24/10/2007
Date last updated
17/04/2017
Titles & IDs
Public title
Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two
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Scientific title
A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy
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Secondary ID [1]
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2007-001162-32
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Secondary ID [2]
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CAMMS32400507
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Universal Trial Number (UTN)
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Trial acronym
CARE-MS II
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis, Relapsing-Remitting
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Alemtuzumab 12 mg
Other interventions - Alemtuzumab 24 mg
Other interventions - Interferon beta-1a
Experimental: Alemtuzumab 12 mg - Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
Experimental: Alemtuzumab 24 mg - Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
Active Comparator: Interferon Beta-1a - Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
Other interventions: Alemtuzumab 12 mg
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: Alemtuzumab 24 mg
Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Sustained Accumulation of Disability (SAD)
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Assessment method [1]
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EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least the next 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.
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Timepoint [1]
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Up to 2 years
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Primary outcome [2]
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Annualized Relapse Rate
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 2 years
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Secondary outcome [1]
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Percentage of Participants Who Were Relapse Free at Year 2
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Assessment method [1]
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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.
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Timepoint [1]
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Year 2
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Secondary outcome [2]
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Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2
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Assessment method [2]
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EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.
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Timepoint [2]
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Baseline, Year 2
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Secondary outcome [3]
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Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, Year 2
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Secondary outcome [4]
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Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2
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Assessment method [4]
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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).
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Timepoint [4]
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Baseline, Year 2
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Eligibility
Key inclusion criteria
- Signed informed consent form (ICF)
- Age 18 to 55 years (inclusive) as of the date the ICF was signed
- Diagnosis of MS per update of McDonald criteria
- Onset of MS symptoms (as determined by a neurologist; could be retrospectively) within
10 years of the date the ICF was signed
- Expanded Disability Status Scale (EDSS) score 0.0 to 5.0 (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
- >=1 MS relapse during treatment with a beta interferon therapy or glatiramer acetate
after having been on that therapy for >=6 months within 10 years of the date the ICF
was signed
- MRI scan demonstrating white matter lesions attributable to MS and meeting at least 1
of the following criteria, as determined by the neurologist or a radiologist: >=9 time
constant 2 (T2) lesions at least 3 millimeter (mm) in any axis; a gadolinium- (Gd-)
enhancing lesion at least 3 mm in any axis plus >=1 brain T2 lesions; and a spinal
cord lesion consistent with MS plus >=1 brain T2 lesion
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Minimum age
18
Years
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Maximum age
55
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Received prior therapy with alemtuzumab
- Current participation in another clinical study or previous participation in CAMMS323
(Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, CARE-MS I)
- Treatment with natalizumab, methotrexate, azathioprine, or cyclosporine in the past 6
months. Participants who received one of these medications more than 6 months before
the date the ICF was signed were eligible for study entry if approval was granted by
Genzyme
- Any progressive form of MS
- History of malignancy (except basal skin cell carcinoma)
- CD4 +, CD8 +, CD19 + (that is, absolute CD3 + CD4 + , CD3 + CD8 + , or CD19 + /mm 3 )
count, absolute neutrophil count less than (<) lower limit of normal (LLN) at
screening; if abnormal cell count(s) returned to within normal limits (WNL),
eligibility could be reassessed
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2011
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Sample size
Target
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Accrual to date
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Final
840
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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Recruitment hospital [2]
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The Wesley Research Institute - Auchenflower
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Recruitment hospital [3]
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Griffith School of Medicine, Gold Coast Campus, Griffith University - Southport
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Clinical Cognitive Research Unit/Clinical Trials, The Queen Elizabeth Hospital, Neurology Department - Woodville South
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Royal Hobart Hospital - Hobart
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Recruitment hospital [6]
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St. Vincent's Hospital, MS Education & Research, Department of Clinical Neurosciences - Fitzroy
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Recruitment hospital [7]
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Austin Health - Heidelberg
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Recruitment hospital [8]
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Royal Melbourne Hospital, Department of Neurology - Parkville
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Recruitment hospital [9]
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Concord Repatriation General Hospital, Neurosciences Department - Concord
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Recruitment hospital [10]
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Southern Neurology - Kogarah
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Recruitment hospital [11]
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Liverpool Hospital, Neurology Department - Liverpool
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Recruitment postcode(s) [1]
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- Westmead
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Recruitment postcode(s) [2]
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4066 - Auchenflower
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Recruitment postcode(s) [3]
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- Southport
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- Woodville South
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Recruitment postcode(s) [5]
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7000 - Hobart
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- Fitzroy
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Recruitment postcode(s) [7]
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- Heidelberg
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Recruitment postcode(s) [8]
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3050 - Parkville
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Recruitment postcode(s) [9]
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- Concord
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Recruitment postcode(s) [10]
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- Kogarah
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Recruitment postcode(s) [11]
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2170 - Liverpool
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Recruitment outside Australia
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Russian Federation
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State/province [96]
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St. Petersburg
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Country [97]
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Serbia
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Belgrade
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Country [98]
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Serbia
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State/province [98]
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Kragujevac
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Country [99]
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Serbia
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Novi Sad
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
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Country [104]
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Sweden
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State/province [104]
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Gothenburg
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Country [105]
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Sweden
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State/province [105]
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Umea
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Ukraine
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State/province [106]
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Kharkov
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Ukraine
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Kyiv
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Country [108]
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Ukraine
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State/province [108]
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Lviv
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Country [109]
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United Kingdom
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State/province [109]
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England
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Country [110]
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United Kingdom
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State/province [110]
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Bristol
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Country [111]
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United Kingdom
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State/province [111]
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Salford
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Genzyme, a Sanofi Company
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Bayer
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Ethics approval
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Summary
Brief summary
The purpose of this study was to establish the efficacy and safety of two different doses of
alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in
comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who
had received an adequate trial of disease-modifying therapies but experienced at least 1
relapse during prior treatment, and who met a minimum severity of disease as measured by
magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive
testing every 3 months.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00548405
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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Medical Monitor
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Genzyme, a Sanofi Company
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00548405
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