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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2007-001162-32
Secondary ID [2] 0 0
CAMMS32400507
Universal Trial Number (UTN)
Trial acronym
CARE-MS II
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
Treatment: Other - Alemtuzumab 12 mg
Treatment: Other - Alemtuzumab 24 mg
Treatment: Other - 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.


Treatment: Other: 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.

Treatment: Other: 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.

Treatment: Other: 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
Treatment: Other
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
* 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2011
Sample size
Target
Accrual to date
Final
840
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
The Wesley Research Institute - Auchenflower
Recruitment hospital [3] 0 0
Griffith School of Medicine, Gold Coast Campus, Griffith University - Southport
Recruitment hospital [4] 0 0
Clinical Cognitive Research Unit/Clinical Trials, The Queen Elizabeth Hospital, Neurology Department - Woodville South
Recruitment hospital [5] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [6] 0 0
St. Vincent's Hospital, MS Education & Research, Department of Clinical Neurosciences - Fitzroy
Recruitment hospital [7] 0 0
Austin Health - Heidelberg
Recruitment hospital [8] 0 0
Royal Melbourne Hospital, Department of Neurology - Parkville
Recruitment hospital [9] 0 0
Concord Repatriation General Hospital, Neurosciences Department - Concord
Recruitment hospital [10] 0 0
Southern Neurology - Kogarah
Recruitment hospital [11] 0 0
Liverpool Hospital, Neurology Department - Liverpool
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
- Southport
Recruitment postcode(s) [4] 0 0
- Woodville South
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
- Fitzroy
Recruitment postcode(s) [7] 0 0
- Heidelberg
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
- Concord
Recruitment postcode(s) [10] 0 0
- Kogarah
Recruitment postcode(s) [11] 0 0
2170 - Liverpool
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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District of Columbia
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Georgia
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Samara
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Russian Federation
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St. Petersburg
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Serbia
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Belgrade
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Serbia
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Kragujevac
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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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Madrid
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Malaga
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Spain
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Sevilla
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Sweden
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Gothenburg
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Sweden
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Umea
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Ukraine
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Kharkov
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Ukraine
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Kyiv
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Ukraine
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Lviv
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United Kingdom
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England
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United Kingdom
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Bristol
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United Kingdom
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Salford
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United Kingdom
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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00548405