This is a Phase II, randomized, open-label, three-arm study comparing low-and high-dose CAMPATH and high-dose Rebif in patients with early, active relapsing-remitting Multiple Sclerosis (MS) who have not been previously treated with immunotherapies other than steroids.

Condition	Treatment or Intervention	Phase
Multiple Sclerosis, Relapsing-Remitting	Drug: CAMPATH/MABCAMPATH	Phase II

Further Study Details: 

Expected Total Enrollment:  180

The aims of treatment for multiple sclerosis (MS) therapy are to prevent the progression of disease and accumulation of long-term disability. This is mainly dependent on axonal loss, which is conditioned by prior inflammation. The hypothesis underlying this study is that aggressive treatment of cerebral inflammation early in the course of MS will protect the patient from disease progression and accumulating disability and will abrogate axonal degeneration. This protocol compares the ability of low- and high-dose CAMPATH/MABCAMPATH monoclonal antibody and high-dose Rebif (Rebif, Ares-Serono) in the following:

• Time to sustained accumulation of disability (SAD);
• Reduction in the frequency of relapses (relapse rate);
• Reduction in tissue damage as assessed by magnetic resonance imaging (MRI); and
• Quality of life.

Ages Eligible for Study:  18 Years   -   50 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Signed, written informed consent.
• Male or non-pregnant, non-lactating female patients, 18 to 50 years of age (inclusive).
• 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.
• EDSS1 score 0.0 to 3.0 (inclusive) at the screening and baseline visits.
• At least 2 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, 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 within 2 weeks prior to randomization. (NB: Serum pregnancy testing will be performed on each occasion.).
• 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 results.
• 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 relapsing-remitting
• Patients currently participating in a clinical trial of an experimental or unapproved/unlicensed therapy

Arizona
      Phoenix Neurological Associates, LTD., Phoenix,  Arizona,  85006,  United States
      Mayo Clinic Scottsdale, Scottsdale,  Arizona,  United States
Arkansas
      Clinical Trials, Inc, Little Rock,  Arkansas,  72205,  United States
California
      The Neurology Center, Oceanside,  California,  92056,  United States
      Multiple Sclerosis Service, Walnut Creek,  California,  94596,  United States
      East Bay Region Associates in Neurology, Berkeley,  California,  94705,  United States
      Neuro-Therapeutics, Inc., Pasadena,  California,  91105,  United States
      Nerve Pro Research, Irvine,  California,  92618,  United States
Florida
      Tampa Neurology Associates, Tampa,  Florida,  33609,  United States
      Cancer Research Network, Plantation,  Florida,  33324,  United States
      Neurological Services of Orlando, Orlando,  Florida,  32806,  United States
      Neurological Associates, Ft. Lauderdale,  Florida,  33334,  United States
Georgia
      Sleep Medicine and Neurology, Columbus,  Georgia,  31901,  United States
      Neurotrials Research, Atlanta,  Georgia,  30342,  United States
Illinois
      Consultants in Neurology, Ltd., Northbrook,  Illinois,  60062,  United States
Indiana
      Fort Wayne Neurological Center, Fort Wayne,  Indiana,  46805,  United States
Kentucky
      Associates in Neurology, P.S.C., Lexington,  Kentucky,  40503,  United States
Maryland
      University of Maryland, Baltimore,  Maryland,  21201,  United States
Michigan
      Michigan Medical P.C. , West Michigan MS Clinic, Grand Rapids,  Michigan,  49525,  United States
      Wayne State University, The School of Medicine, Dept of Neurology, Detroit,  Michigan,  48201,  United States
Minnesota
      Mayo Clinic and Foundation, Rochester,  Minnesota,  55905,  United States
Nevada
      Nevada Neurological Consultants, Henderson,  Nevada,  89052,  United States
New York
      University Hospital Stony Brook, Stony Brook,  New York,  11794,  United States
      MS Comprehensive Care Center, White Plains,  New York,  United States
      University of Rochester, Rochester,  New York,  14642,  United States
North Carolina
      Triad Neurology Services, Winston Salem,  North Carolina,  27103,  United States
Ohio
      Research Resources, Inc., West Chester,  Ohio,  45069,  United States
Oklahoma
      Neurological Associates of Tulsa, Inc., Tulsa,  Oklahoma,  74136,  United States
Pennsylvania
      Neurosciences Research, MS Center, Allentown,  Pennsylvania,  18103,  United States
Tennessee
      Knoxville Neurology Associates, Baptist Hospital, Knoxville,  Tennessee,  37920,  United States
Texas
      Central Texas Neurology Consultants, Austin,  Texas,  78681,  United States
      Neurology Center of San Antonio, San Antonio,  Texas,  78212,  United States
      Dallas Neurological Associates, Richardson,  Texas,  75080,  United States
      Baylor College of Medicine, Dept. of Neurology, Houston,  Texas,  United States
      Integra Clinical Research, LLC, San Antonio,  Texas,  78229,  United States
Croatia
      Zagreb,  Croatia
United Kingdom, England
      Cambridge,  England,  United Kingdom

Study ID Numbers:  CAMMS223
Record last reviewed:  April 2005
Last Updated:  April 5, 2005
Record first received:  December 19, 2002
ClinicalTrials.gov Identifier:  NCT00050778
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08