Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.

• Register: EUCTR
• Last refreshed on: 26 June 2012
• Main ID: EUCTR2007-001162-32-PL
• Date of registration: 24/10/2008
• Prospective Registration: No
• Primary sponsor: Genzyme Corporation
• Public title: Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.
• 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 Scleroris Who Have Relapsed On Therapy - CARE MS-II
• Date of first enrolment: 21/10/2008
• Target sample size: 840
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001162-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: yes Other trial design description: Rater-blinded If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, France, Germany, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, Serbia, Spain, Sweden, Ukraine, United Kingdom, United States

Contacts

• Name: Medical Information Genzyme Europe
• Affiliation: Genzyme Europe B.V.

• Name: Medical Information Genzyme Europe
• Affiliation: Genzyme Europe B.V.

Key inclusion & exclusion criteria

Inclusion criteria:
•Diagnosis of MS and MRI scan demonstrating white matter lesions attributable to MS
•Onset of MS symptoms within 10 years
•EDSS score 0.0 to 5.0
•=2 MS attacks within 24 months, with =1 attack within 12 months
•=1 MS attack (relapse)during treatment with a beta interferon therapy or glatiramer acetate after having been on that therapy for at least 6 months within 10 years
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 840
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
•Previous treatment with alemtuzumab
•Previous treatment with any investigational drug (i.e. a medication that is not approved at any dose or for any indication)
•Treatment with natalizumab, methotrexate, azothioprine or cyclosporine in the past 6 months
•Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab, or any other immunosuppressive, or cytotoxic therapy (other than steroid treatment)
•Any progressive form of MS
•Any disability acquired from trauma or another illness that could interfere with evaluation of disability due to MS
•Major systemic disease that cannot be treated or adequately controlled by therapy
•Active infection or high risk for infection
•Autoimmune disorder (other than MS)
•Impaired hepatic or renal function
•History of malignancy, except basal skin cell carcinoma
•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
•Known bleeding disorder
•Of childbearing potential with a positive serum pregnancy test, pregnant, or lactating
•Current participation in another clinical study or previous participation in CAMMS323
•Previous hypersensitivity reaction to any immunoglobulin product
•Known allergy or intolerance to interferon beta, human albumin, or mannitol
•Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
•Inability to self-administer subcutaneous (SC) injections or receive SC injections from caregiver
•Inability to undergo MRI with gadolinium administration
•Unwilling to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis
MedDRA version: 14.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: MabCampath ®

Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Alemtuzumab
Other descriptive name: Alemtuzumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-

Primary Outcome(s)

Primary end point(s): •Time to Sustained Accumulation of Disability (SAD)
•Relapse Rate

Main Objective: The study will enroll patients who have received an adequate trial of disease-modifying therapies but continued to relapse while being
treated, and who meet a minimum severity of disease as measured by magnetic resonance imaging (MRI).
The main objective of this study is to establish the efficacy of two different doses of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with Rebif® (interferon beta-1a).

Secondary Objective: To establish the safety of two different doses of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison
with Rebif® (interferon beta-1a).

Timepoint(s) of evaluation of this end point: 24 Months

Secondary Outcome(s)

Secondary end point(s): •Proportion of patients who are relapse free at Year 2
•Change from baseline in EDSS (Expanded Disability Status Scale)
•Acquisition of disability as measured by change from baseline in Multiple Sclerosis Functional Composite (MSFC)
•Percent change from baseline in MRI-T2 hyperintense lesion volume at Year 2

Timepoint(s) of evaluation of this end point: 24 Months

Secondary ID(s)

2007-001162-32-GB

CAMMS32400507

Source(s) of Monetary Support

Genzyme Corporation

Bayer Schering Pharma