Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000435381
Ethics application status
Approved
Date submitted
18/06/2008
Date registered
29/08/2008
Date last updated
1/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Alemtuzumab and Rebif (registered trademark) 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 (registered trademark)) on Relapse Rate and Time to Sustained Accumulation of Disability in Treatment-Naive Patients with Relapsing-Remitting Multiple Sclerosis
Secondary ID [1] 524 0
ClinicalTrials.gov NCT00530348
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 2309 0
Condition category
Condition code
Neurological 2980 2980 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
alemtuzumab; 12 mg per day administered through intravenous therapy (IV), once a day for 5 consecutive days at Month 0 and 12 mg per day administered through IV, once a day for 3 consecutive days at Month 12
Intervention code [1] 2030 0
Treatment: Drugs
Comparator / control treatment
Comparator: interferon beta-1a (Rebif (registered trademark)); 44 micrograms (mcg) administered 3-times weekly by subcutaneous (SC) injections for 2 years.
Control group
Active

Outcomes
Primary outcome [1] 3308 0
Time to Sustained Accumulation of Disability (SAD) based on increases in scores on the Expanded Disability Status Scale (EDSS) lasting at least 6 months
Timepoint [1] 3308 0
Monitored at baseline and quarterly thereafter for 2 years.
Primary outcome [2] 3309 0
Relapse Rate based on patient report with physician confirmation of objective neurologic changes
Timepoint [2] 3309 0
Monitored continuously for 2 years.
Secondary outcome [1] 5512 0
Proportion of patients who are relapse free at Year 2
Timepoint [1] 5512 0
2 years
Secondary outcome [2] 5513 0
Change from baseline in EDSS
Timepoint [2] 5513 0
Monitored at baseline and quarterly thereafter for 2 years.
Secondary outcome [3] 5514 0
Acquisition of disability as measured by change from baseline in Multiple Sclerosis Functional Composite (MSFC)
Timepoint [3] 5514 0
Monitored at baseline and quarterly thereafter for 2 years.
Secondary outcome [4] 5558 0
Percent change from baseline in magnetic resonance imaging (MRI) T2-weighted hyperintense lesion volume at Year 2
Timepoint [4] 5558 0
Monitored at baseline and annually thereafter for 2 years.
Secondary outcome [5] 7881 0
Safety, based on adverse event reporting and laboratory testing. These are safety provisions outlined in the protocol and not secondary outcomes.
Timepoint [5] 7881 0
Monitored continuously, including monthly blood tests.

Eligibility
Key inclusion criteria
1. Diagnosis of MS and cranial MRI scan demonstrating white matter lesions attributable to MS within 5 years
2. Onset of MS symptoms within 5 years
3. EDSS score 0.0 to 3.0
4. Greater than or equal to 2 MS attacks within 24 months, with greater than or equal to 1 attack within 12 months
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Received prior therapy for MS other than corticosteroids
2. Exposure to immunosuppressive or immunomodulatory agents other than systemic corticosteroid treatment
3. Received treatment with a monoclonal antibody for any reason
4. Previous treatment with any investigational drug (i.e. medication that is not approved at any dose for any indication)
5. Has any progressive form of MS
6. Any disability acquired from trauma or another illness that could interfere with evaluation of disability due to MS
7. Major systemic disease that cannot be treated or adequately controlled by therapy
8. Active infection or high risk for infection
9. Autoimmune disorder (other than MS)
10. Impaired hepatic or renal function
11. History of malignancy, except basal skin cell carcinoma
12. Medical, psychiatric, cognitive, or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
13. Known bleeding disorder
14. Of childbearing potential with a positive serum pregnancy test, pregnant, or lactating
15. Current participation in another clinical study
16. Previous hypersensitivity reaction to any immunoglobulin product
17. Known allergy or intolerance to interferon beta, human albumin, or mannitol
18. Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
19. Inability to self-administer subcutaneous (SC) injections or receive SC injections from caregiver 20. Inability to undergo MRI with gadolinium administration
21. Unwilling to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only)

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?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
7/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
581
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1381 0
2139
Recruitment postcode(s) [2] 1120 0
2145
Recruitment postcode(s) [3] 893 0
3050
Recruitment postcode(s) [4] 892 0
3065
Recruitment postcode(s) [5] 891 0
3084
Recruitment postcode(s) [6] 894 0
4066
Recruitment postcode(s) [7] 639 0
4215
Recruitment postcode(s) [8] 640 0
5011
Recruitment postcode(s) [9] 1811 0
7000
Recruitment outside Australia
Country [1] 566 0
Argentina
State/province [1] 566 0
Country [2] 567 0
Austria
State/province [2] 567 0
Country [3] 568 0
Brazil
State/province [3] 568 0
Country [4] 569 0
Canada
State/province [4] 569 0
Country [5] 570 0
Croatia
State/province [5] 570 0
Country [6] 571 0
Czech Republic
State/province [6] 571 0
Country [7] 572 0
France
State/province [7] 572 0
Country [8] 573 0
Germany
State/province [8] 573 0
Country [9] 574 0
Mexico
State/province [9] 574 0
Country [10] 575 0
Poland
State/province [10] 575 0
Country [11] 576 0
Russian Federation
State/province [11] 576 0
Country [12] 577 0
Serbia and Montenegro
State/province [12] 577 0
Country [13] 578 0
Sweden
State/province [13] 578 0
Country [14] 579 0
United Kingdom
State/province [14] 579 0
Country [15] 580 0
United States of America
State/province [15] 580 0

Funding & Sponsors
Funding source category [1] 2569 0
Commercial sector/Industry
Name [1] 2569 0
Genzyme Corporation
Country [1] 2569 0
United States of America
Funding source category [2] 2570 0
Commercial sector/Industry
Name [2] 2570 0
Bayer Schering Pharma AG
Country [2] 2570 0
Germany
Primary sponsor type
Commercial sector/Industry
Name
Genzyme Corporation
Address
500 Kendall StreetCambridge, Massachusetts 02142
Country
United States of America
Secondary sponsor category [1] 3129 0
None
Name [1] 3129 0
Address [1] 3129 0
Country [1] 3129 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5072 0
Gold Coast Health Services District Research Ethics Committee
Ethics committee address [1] 5072 0
108 Nerang Street, Southport, QLD 4215
Ethics committee country [1] 5072 0
Australia
Date submitted for ethics approval [1] 5072 0
Approval date [1] 5072 0
30/10/2007
Ethics approval number [1] 5072 0
30/10/2007

Summary
Brief summary
The purpose of this study is to establish the efficacy and safety of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with Rebif (registered trademark for interferon beta-1a). The study will enroll patients who have not previously received treatment to suppress MS, except steroids. Patients will have monthly laboratory tests, and comprehensive testing every 3 months.
Every patient will receive active treatment; there is no placebo. Patients who qualify will be randomly assigned to treatment with either alemtuzumab or Rebif (registered trademark) at a 2:1 ratio (ie, 2 given alemtuzumab for every 1 given Rebif (registered trademark). Patients will not be able to guess which treatment will be randomly assigned to them. Alemtuzumab will be administered in two annual cycles, once at the beginning of the study and again 1 year later. Rebif (registered trademark) will be self-injected 3 times per week for 2 years. All patients will be required to return to their study site every 3 months for neurologic assessment. In addition, safety-related laboratory tests will be performed at least monthly. Participation in this study will end 2 years after the start of treatment for each patient. Additionally, all patients who receive alemtuzumab will be followed in an extension study for safety and efficacy assessments. Patients who receive Rebif (registered trademark) and complete 2 years on study may be eligible to receive alemtuzumab in an extension study.
Trial website
Trial related presentations / publications
1) Coles AJ, Cox A, Le Page E, et al. The window of therapeutic opportunity in multiple sclerosis: evidence from monoclonal antibody therapy. J Neurol. 2006;253(1);98-108.
2) 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.
Public notes

Contacts
Principal investigator
Name 28016 0
Address 28016 0
Country 28016 0
Phone 28016 0
Fax 28016 0
Email 28016 0
Contact person for public queries
Name 11173 0
Genzyme Medical Information
Address 11173 0
Level 1, Building C,12-24 Talavera Road
North Ryde NSW 2113
Mailing Address: PO Box 282, North Ryde B/C NSW 1670, Australia
Country 11173 0
Australia
Phone 11173 0
1800 359 131
Fax 11173 0
1800 232 565
Email 11173 0
medinfo_ANZ@genzyme.com
Contact person for scientific queries
Name 2101 0
Genzyme Medical Information
Address 2101 0
Level 1, Building C,12-24 Talavera Road
North Ryde NSW 2113
Mailing Address: PO Box 282, North Ryde B/C NSW 1670, Australia
Country 2101 0
Australia
Phone 2101 0
1800 359 131
Fax 2101 0
1800 232 565
Email 2101 0
medinfo_ANZ@genzyme.com

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

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