A Study to Evaluate Rituximab in Adults With Relapsing Remitting Multiple Sclerosis
NCT ID: NCT00097188
Last Updated: 2014-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
104 participants
INTERVENTIONAL
2004-12-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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rituximab
Eligibility Criteria
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Inclusion Criteria
* Age 18--55 years, inclusive
* Diagnosis of relapsing MS, as defined by McDonald Criteria 1--4
* History of at least one relapse in the subject's medical records during the 1 year prior to randomization
* EDSS at screening between 0 and 5.0 points, inclusive
* For subjects of reproductive potential (males and females), ability and willingness to use a reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier) during the study, including the safety follow-up period, and for up to 1 year after their last dose of study drug, even if they have discontinued early from the study
Exclusion Criteria
* Incompatibility with MRI
* Lack of peripheral venous access
* History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies
* Known active bacterial, viral, fungal, or mycobacterial infection, or other infection (including atypical mycobacterial disease, but excluding fungal infections of nail beds or recurrent herpes infections), or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 30 days prior to screening or oral antibiotics within 14 days prior to screening
* History or presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV, or syphilis)
* History of cancer, including solid tumors and hematologic malignancies (except fully resolved and resected cutaneous basal cell and squamous cell carcinomas of the skin)
* History of alcohol or drug abuse within 6 months prior to screening
* History of or currently active primary or secondary immunodeficiency
* Presence of significant, uncontrolled disease of the cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal systems
* Diagnosis of secondary progressive, primary progressive, or progressive relapsing MS
* History or presence of vascular disease potentially affecting brain or spinal cord (e.g., stroke, transient ischemic attack, severe carotid stenosis, aortic aneurysm, intracranial aneurysm, hemorrhage, arteriovenous malformation)
* History or presence of myelopathy due to spinal cord compression by disk or vertebral disease
* History of severe, clinically significant CNS trauma (e.g., cerebral contusion, spinal cord compression)
* History of intracranial or intraspinal tumor (e.g., meningioma, glioma)
* History or presence of potential metabolic cause of encephalopathy or myelopathy (e.g., untreated vitamin B12 deficiency, untreated thyroid deficiency)
* History or presence of infectious causes of encephalopathy or myelopathy (e.g., syphilis, Lyme disease, human T-cell lymphotropic virus type 1 \[HTLV-1\], herpes zoster myelopathy)
* Neuromyelitis optica
* History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, antiphospholipid antibody syndrome, Sjogren�s syndrome, Behcet disease)
* History or presence of sarcoidosis
* Relapse within 30 days prior to randomization
* Previous treatment with rituximab (MabThera(R)/Rituxan(R))
* Treatment with any investigational agent within 90 days of randomization or five half-lives of the investigational drug (whichever is longer)
* Receipt of a live vaccine within 30 days prior to randomization
* Previous treatment with lymphocyte-depleting therapies (e.g., Campath(R), anti-CD4, cladribine, total body irradiation, bone marrow transplantation)
* Treatment with cyclophosphamide or mitoxantrone within 12 months of randomization
* Systemic corticosteroid therapy within 30 days of randomization
* Treatment with IFN-Beta; or Copaxone(R) within 60 days of randomization
* Treatment with IVIG within 60 days of randomization
* Plasmapheresis within 60 days of randomization
* Treatment with non-lymphocyte depleting immunosuppressive therapies (e.g., azathioprine, mycophenolate mofetil, cyclosporine) within 90 days prior to randomization
* Statins or hormone replacement therapy started within 30 days of randomization
* Positive pregnancy test
* B-cell count \<1.1% (reported as percent CD19)
* Vitamin B12 below the lower limit of normal with an abnormal methylmalonic acid level
* Positive rapid plasma reagin
* Serum creatinine \>1.4 mg/dL for women or \>1.6 mg/dL for men
* Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) \>2.5 x the upper limit of normal
* Platelet count \<100,000/mL
* Hemoglobin \<8.5 g/dL
* Neutrophils \<1.5 x 10\^3/mL
* Serum IgG levels below 5.65 mg/mL and serum IgM levels below 0.55 mg/mL
* Findings on brain MRI scan consistent with clinically significant conditions other than MS
* Electrocardiogram (ECG) showing significant abnormality that the treating investigator determines may jeopardize the subject's health (i.e., acute ischemia, left bundle branch, or bifascicular block)
18 Years
55 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Principal Investigators
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Craig Smith, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Phoenix Neurological Associates
Phoenix, Arizona, United States
Loma Linda University
Loma Linda, California, United States
Sutter Gould Medical Foundation
Modesto, California, United States
University Of California At Davis
Sacramento, California, United States
Neurological Research Institute Of East Bay
Walnut Creek, California, United States
Neurology Associates, P.A.
Maitland, Florida, United States
Multiple Sclerosis Center of Brevard
Melbourne, Florida, United States
Neurological Services Of Orlando
Orlando, Florida, United States
Neurological Associates
Pompano Beach, Florida, United States
MS Center of Vero Beach
Vero Beach, Florida, United States
MS Center Of Atlanta
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
University Of Kansas Medical Center
Kansas City, Kansas, United States
Kentucky Neuroscience Research
Louisville, Kentucky, United States
University of Maryland Hospital MS Center
Baltimore, Maryland, United States
Michigan Institute For Neurological Disorders
Farmington Hills, Michigan, United States
Deaconess Billings Clinical Research Division
Billings, Montana, United States
Albany Medical Center
Albany, New York, United States
Meritcare Neuroscience Clinic
Fargo, North Dakota, United States
Neurology and Neuroscience Assoc.,INC
Akron, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
University Of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
Neurology Specialists of Dallas, PA
Dallas, Texas, United States
Maxine Mesinger MS Clinic/ Baylor College of Medicine
Houston, Texas, United States
Neurology Clinic of San Antonio
San Antonio, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Holy Family MS Center
Spokane, Washington, United States
Neurology and Neurosurgery Associates of Tacoma, Inc., P.S.
Tacoma, Washington, United States
St. Luke's Medical Center/Center for Neurological Disorders
Milwaukee, Wisconsin, United States
Countries
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References
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Hauser SL, Waubant E, Arnold DL, Vollmer T, Antel J, Fox RJ, Bar-Or A, Panzara M, Sarkar N, Agarwal S, Langer-Gould A, Smith CH; HERMES Trial Group. B-cell depletion with rituximab in relapsing-remitting multiple sclerosis. N Engl J Med. 2008 Feb 14;358(7):676-88. doi: 10.1056/NEJMoa0706383.
Smith CH, Waubant E, Langer-Gould A. Absence of neuromyelitis optica IgG antibody in an active relapsing-remitting multiple sclerosis population. J Neuroophthalmol. 2009 Jun;29(2):104-6. doi: 10.1097/WNO.0b013e3181a63606.
Other Identifiers
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U2787g
Identifier Type: -
Identifier Source: org_study_id
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