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A Phase II Study Comparing Low- and High-Dose CAMPATH and High-Dose Rebif in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Phase II Study Comparing Low- and High-Dose CAMPATH and High-Dose Rebif in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Phase II Study Comparing Low- and High-Dose CAMPATH and High-Dose Rebif in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis Clinical research trials and A Phase II Study Comparing Low- and High-Dose CAMPATH and High-Dose Rebif in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including A Phase II Study Comparing Low- and High-Dose CAMPATH and High-Dose Rebif in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis. A Phase II Study Comparing Low- and High-Dose CAMPATH and High-Dose Rebif in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Phase II Study Comparing Low- and High-Dose CAMPATH and High-Dose Rebif in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis clinical trial. Test subjects typically receive the most effective healthcare possible for their A Phase II Study Comparing Low- and High-Dose CAMPATH and High-Dose Rebif in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase II Study Comparing Low- and High-Dose CAMPATH and High-Dose Rebif in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis  A Phase II Study Comparing Low- and High-Dose CAMPATH and High-Dose Rebif in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis
A Phase II Study Comparing Low- and High-Dose CAMPATH and High-Dose Rebif in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis
For Condition: Multiple Sclerosis, Relapsing-Remitting
Status: No longer recruiting
Sponsor(s): ILEX Pharmaceuticals ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 180
Location and Contact Information:
Wayne State University, The School of Medicine, Dept of Neurology
Detroit, Michigan, 48201
United States
Research Resources, Inc.
West Chester, Ohio, 45069
United States
Mayo Clinic Scottsdale
Scottsdale, Arizona,
United States
Cancer Research Network
Plantation, Florida, 33324
United States
Phoenix Neurological Associates, LTD.
Phoenix, Arizona, 85006
United States
Dallas Neurological Associates
Richardson, Texas, 75080
United States
Neurology Center of San Antonio
San Antonio, Texas, 78212
United States
Neurological Associates of Tulsa, Inc.
Tulsa, Oklahoma, 74136
United States
Michigan Medical P.C. , West Michigan MS Clinic
Grand Rapids, Michigan, 49525
United States
Baylor College of Medicine, Dept. of Neurology
Houston, Texas,
United States
East Bay Region Associates in Neurology
Berkeley, California, 94705
United States
Fort Wayne Neurological Center
Ft. Wayne, Indiana, 46805
United States
Neurological Associates
Ft. Lauderdale, Florida, 33334
United States
Nevada Neurological Consultants
Henderson, Nevada, 89052
United States
Central Texas Neurology Consultants
Austin, Texas, 78681
United States
Associates in Neurology, P.S.C.
Lexington, Kentucky, 40503
United States
University of Rochester
Rochester, New York, 14642
United States
University of Maryland
Baltimore, Maryland, 21201
United States
Neurological Services of Orlando
Orlando, Florida, 32806
United States
University Hospital Stony Brook
Stony Brook, New York, 11794
United States
Consultants in Neurology, Ltd.
Northbrook, Illinois, 60062
United States
MS Comprehensive Care Center
White Plains, New York,
United States
Tampa Neurology Associates
Tampa, Florida, 33609
United States
Clinical Trials, Inc
Little Rock, Arkansas, 72205
United States
Neurotrials Research
Atlanta, Georgia, 30342
United States
Multiple Sclerosis Service
Walnut Creek, California, 94596
United States
Integra Clinical Research, LLC
San Antonio, Texas, 78229
United States
The Neurology Center
Oceanside, California, 92056
United States
Nerve Pro Research
Irvine, California, 92618
United States
Neuro-Therapeutics, Inc.
Pasadena, California, 91105
United States
Triad Neurology Services
Winston Salem, North Carolina, 27103
United States
Mayo Clinic and Foundation
Rochester, Minnesota, 55905
United States
Sleep Medicine and Neurology
Columbus, Georgia, 31901
United States
Neurosciences Research, MS Center
Allentown, Pennsylvania, 18103
United States
Knoxville Neurology Associates, Baptist Hospital
Knoxville, Tennessee, 37920
United States
Additional Information:
Study ID Numbers: CAMMS223;
Study Start Date: November 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050778
Other Multiple Sclerosis, Relapsing-Remitting Studies:
1. A Phase II Study Comparing Low- and High-Dose CAMPATH and High-Dose Rebif in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis
2. Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
3. Treatment of Multiple Sclerosis using Over the Counter Inosine
4. Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis
5. Safety of RG2077 in Patients With Multiple Sclerosis
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A Phase II Study Comparing Low- and High-Dose CAMPATH and High-Dose Rebif in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis
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