Trial Search Results

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Genzyme, a Sanofi Company

Collaborator: Bayer

Stanford Investigator(s):

Intervention(s):

  • Biological: Alemtuzumab 12 mg
  • Biological: Alemtuzumab 24 mg
  • Biological: Interferon beta-1a

Phase:

Phase 3

Eligibility


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

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

Ages Eligible for Study

18 Years - 55 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria Coburn
6507369551
Not Recruiting