Trial record 3 of 5 for:    alemtuzumab | Interventional Studies | multiple sclerosis | Phase 3

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One (CARE-MS I)

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00530348
First received: September 13, 2007
Last updated: May 31, 2012
Last verified: May 2012

September 13, 2007
May 31, 2012
September 2007
May 2011   (final data collection date for primary outcome measure)
  • Time to Sustained Accumulation of Disability (SAD) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Relapse Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Time to Sustained Accumulation of Disability (SAD) [ Time Frame: 2 years ]
  • Relapse Rate [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00530348 on ClinicalTrials.gov Archive Site
  • Proportion of patients who are relapse free at Year 2 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change from baseline in Expanded Disability Status Scale (EDSS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Acquisition of disability as measured by change from baseline in Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Percent change from baseline in magnetic resonance imaging (MRI)-T2 hyperintense lesion volume at Year 2 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Proportion of patients who are relapse free at Year 2 [ Time Frame: 2 years ]
  • Change from baseline in EDSS [ Time Frame: 2 years ]
  • Acquisition of disability as measured by change from baseline in MSFC [ Time Frame: 2 years ]
  • Percent change from baseline in MRI-T2 hyperintense lesion volume at Year 2 [ Time Frame: 2 years ]
Not Provided
Not Provided
 
Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One
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

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® (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® at a 2:1 ratio (ie, 2 given alemtuzumab for every 1 given Rebif®). Alemtuzumab will be administered in two annual cycles, once at the beginning of the study and again 1 year later. Rebif® 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, patients who receive alemtuzumab may be followed in CAMMS03409 (NCT 00930553) an extension study for safety and efficacy assessments. Patients who receive Rebif® and complete 2 years on study may be eligible to receive alemtuzumab on the extension study.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
  • Biological: alemtuzumab
    12 mg per day administered through 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.
  • Biological: interferon beta-1a (Rebif®)
    44 mcg administered 3-times weekly by SC injections for 2 years
  • Experimental: alemtuzumab 12 mg
    Intervention: Biological: alemtuzumab
  • Active Comparator: interferon beta-1a (Rebif ®) 44mcg
    Intervention: Biological: interferon beta-1a (Rebif®)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
581
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of MS and cranial MRI scan demonstrating white matter lesions attributable to MS within 5 years
  • Onset of MS symptoms within 5 years
  • EDSS score 0.0 to 3.0
  • ≥2 MS attacks within 24 months, with ≥1 attack within 12 months

Exclusion Criteria:

  • Received prior therapy for MS other than corticosteroids
  • Exposure to immunosuppressive or immunomodulatory agents other than systemic corticosteroid treatment
  • Received treatment with a monoclonal antibody for any reason
  • Previous treatment with any investigational drug (i.e. medication that is not approved at any dose for any indication)
  • Has 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
  • 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)
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Canada,   Croatia,   Czech Republic,   France,   Germany,   Mexico,   Poland,   Russian Federation,   Serbia,   Sweden,   Ukraine,   United Kingdom
 
NCT00530348
CAMMS323, ISRCTN21534255, ACTRN12608000435381, CARE-MS I
Yes
Genzyme, a Sanofi Company
Genzyme, a Sanofi Company
Bayer
Study Director: Medical Monitor Genzyme, a Sanofi Company
Genzyme, a Sanofi Company
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP