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Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two
Not Recruiting
Trial ID: NCT00548405
Purpose
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.
Official 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 Sclerosis Who Have Relapsed On Therapy
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
Intervention(s):
biological: Alemtuzumab 12 mg
biological: Alemtuzumab 24 mg
biological: Interferon beta-1a
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Maria Coburn
6507369551