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A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis

Phase 2
18 Years
50 Years
Open (Enrolling)
Multiple Sclerosis, Relapsing-Remitting

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Trial Information

A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis

The aims of treatment for multiple sclerosis (MS) therapy are to prevent the progression of
disease and accumulation of long-term disability. The hypothesis underlying this study is
that aggressive treatment of inflammation in the brain early in the course of MS will
protect the patient from disease progression and accumulating disability.

This protocol compares two different doses of alemtuzumab and Rebif® to evaluate the kind of
side effects that patients experience and to evaluate wich drug is better at:

- Slowing the sustained accumulation of disability in patients with MS

- Reducing the frequency of relapses that patients with MS experience);

- Reducing the effects of MS on the brain, as assessed by magnetic resonance imaging

Patients who receive alemtuzumab during the initial 36-month treatment period may be
eligible for additional alemtuzumab retreatment on either a fixed or an as-needed schedule
to evaluate:

- How long the effects of prior alemtuzumab treatment last;

- If additional treatments with alemtuzumab continue to reduce the effects of MS; and

- What kind of side effects patients experience once patients begin taking alemtuzumab

Inclusion Criteria:

- Signed informed consent form.

- Male or non-pregnant, non-lactating female patients, 18 to 50 years of age

- Diagnosis of MS per McDonald's update of the Poser criteria, including cranial MRI
consistent with those criteria.

- Onset of first MS symptoms within 3 years prior to screening.

- EDSS score 0.0 to 3.0 (inclusive) at the screening and baseline visits.

- At least 2 completed clinical episodes of MS in the 2 years prior to study entry (ie,
the initial event if within 2 years of study entry plus ≥1 relapse, or ≥2 relapses if
the initial event was between 2 and 3 years prior to study entry).

- In addition to the clinical criteria (3 to 6 above), ≥1 enhancing lesion on any 1 of
the up to 4 screening gadolinium-enhanced MRI scans during a maximum 3-month run-in
period (inclusive of the Month 0 baseline scan).

Exclusion Criteria:

- Previous immunotherapy for MS other than steroids, including treatment with
interferons, intravenous immunoglobulin, glatiramer acetate, and mitoxantrone.

- Personal history of thyroid autoimmune disease.

- Personal history of clinically significant autoimmune disease (eg, inflammatory bowel
disease, diabetes, lupus, severe asthma).

- History of thyroid carcinoma (previous thyroid adenoma is acceptable and is not to be
considered an exclusion criterion).

- History of malignancy (except for basal cell skin carcinoma in which situation the
patient is eligible only if disease-free for more or equal to 5 years).

- Any disability acquired from trauma or another illness that, in the opinion of the
investigator, could interfere with evaluation of disability due to MS.

- Previous treatment with CAMPATH.

- History of anaphylaxis following exposure to humanized monoclonal antibodies.

- Inability to undergo MRI with gadolinium administration.

- Female patients with childbearing potential with a positive serum pregnancy test at
screening or baseline. (NB: Serum pregnancy testing will be performed on each

- Male and female patients who do not agree to use effective contraceptive method(s)
during the study.

- Impaired renal function (ie, serum creatinine larger or equal to 2 times the
Institutional upper limit of normal [ULN]).

- Untreated, major depressive disorder (MDD).

- Epileptic seizures that are not adequately controlled by treatment.

- Suicidal ideation.

- Major systemic disease or other illness that would, in the opinion of the
investigator, compromise patient safety or interfere with the interpretation of study

- Abnormal CD4 count or significantly abnormal thyroid function; presence of anti-TSH
receptor antibodies; known seropositivity for HIV.

- Intolerance of pulsed corticosteroids, especially a history of steroid psychosis.

- Presence of a monoclonal paraprotein.

- Patients who, in the opinion of the investigator, have any form of MS other than

- Patients currently participating in a clinical trial of an experimental or
unapproved/unlicensed therapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Sustained Accumulation of Disability (SAD), Confirmed Through 6 Months

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2002

Completion Date:

June 2013

Related Keywords:

  • Multiple Sclerosis, Relapsing-Remitting
  • Multiple Sclerosis
  • Active Relapsing-Remitting Multiple Sclerosis
  • Multiple Sclerosis
  • Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting



Mayo Clinic Scottsdale Scottsdale, Arizona  85259
University of Maryland Baltimore, Maryland  21201
Clinical Trials, Inc Little Rock, Arkansas  72205
East Bay Region Associates in Neurology Berkeley, California  94705
Nerve Pro Research Irvine, California  92618
Neuro-Therapeutics, Inc. Pasadena, California  91105
Multiple Sclerosis Service Walnut Creek, California  94596
Colorado Neurology & Headache Center Denver, Colorado  80218
Neurological Services of Orlando Orlando, Florida  32806
Neurological Associates Sunrise, Florida  33351
Tampa Neurology Associates Tampa, Florida  33609
Sleep Medicine and Neurology Columbus, Georgia  31901
Medical Research & Health Education Foundation Columbus, Georgia  31909
Consultants in Neurology, Ltd. Northbrook, Illinois  60062
Fort Wayne Neurological Center Fort Wayne, Indiana  46805
Associates in Neurology, P.S.C. Lexington, Kentucky  40503
Wayne State University, The School of Medicine, Dept of Neurology Detroit, Michigan  48201
Michigan Institute for Neurological Disorders Farmington, Michigan  48334
Michigan Medical P.C. , West Michigan MS Clinic Grand Rapids, Michigan  49525
Mayo Clinic and Foundation Rochester, Minnesota  55905
Nevada Neurological Consultants Henderson, Nevada  89052
University Hospital Stony Brook Stony Brook, New York  11794
Triad Neurology Services Winston-Salem, North Carolina  27103
Neurological Associates of Tulsa, Inc. Tulsa, Oklahoma  74136
Neurosciences Research, MS Center Allentown, Pennsylvania  18103
Knoxville Neurology Associates, Baptist Hospital Knoxville, Tennessee  37920
Central Texas Neurology Consultants Austin, Texas  78681
Baylor College of Medicine, Dept. of Neurology Houston, Texas  
Dallas Neurological Associates Richardson, Texas  75080
Neurology Center of San Antonio San Antonio, Texas  78212
Integra Clinical Research, LLC San Antonio, Texas  78229