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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 Patient

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Trial Conditions
  • Multiple Sclerosis, Relapsing-Remitting
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18  - 55 

Gender:
Both

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

Gender: Both
Steward Physician(s)
  • Medical Monitor
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Biological
  • Alemtuzumab 12 mg
  • Alemtuzumab 24 mg
  • Interferon beta-1a
Physician Researcher

Investigator Name:

  • Medical Monitor

Other Information

Sponsor: Genzyme, a Sanofi Company
Phase: Phase 3
Trial ID: NCT00548405
Volunteers:  Not Accepting Healthy Volunteers

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