Education and Training
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.
Intervention(s):
- biological: Alemtuzumab 12 mg
- biological: Alemtuzumab 24 mg
- biological: Interferon beta-1a
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