A Study to Evaluate Rituximab in Adults With Relapsing Remitting Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00097188
Recruitment Status : Completed
First Posted : November 19, 2004
Last Update Posted : March 4, 2014
Information provided by:
Genentech, Inc.

Brief Summary:
This is a Phase II, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of Rituximab in adults with RRMS.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: rituximab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in Adults With Relapsing Remitting Multiple Sclerosis
Study Start Date : December 2004
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

Primary Outcome Measures :
  1. To investigate the efficacy of rituximab compared with placebo, as measured by MRI scans of the brain for the total number of lesions observed, and to evaluate the safety and tolerability of rituximab in subjects with RRMS.

Secondary Outcome Measures :
  1. To evaluate the efficacy of rituximab compared with placebo.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ability and willingness to provide written informed consent and to comply with the schedule of protocol assessments
  • 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:

  • Pregnancy or lactation
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00097188

  Hide Study Locations
United States, Arizona
Phoenix Neurological Associates
Phoenix, Arizona, United States, 85006
United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sutter Gould Medical Foundation
Modesto, California, United States, 95355
University Of California At Davis
Sacramento, California, United States, 95817
Neurological Research Institute Of East Bay
Walnut Creek, California, United States, 94596
United States, Florida
Neurology Associates, P.A.
Maitland, Florida, United States, 32751
Multiple Sclerosis Center of Brevard
Melbourne, Florida, United States, 32940
Neurological Services Of Orlando
Orlando, Florida, United States, 32806
Neurological Associates
Pompano Beach, Florida, United States, 33060
MS Center of Vero Beach
Vero Beach, Florida, United States, 32960
United States, Georgia
MS Center Of Atlanta
Atlanta, Georgia, United States, 30327
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Kansas
University Of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
Kentucky Neuroscience Research
Louisville, Kentucky, United States, 40202
United States, Maryland
University of Maryland Hospital MS Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Michigan Institute For Neurological Disorders
Farmington Hills, Michigan, United States, 48334
United States, Montana
Deaconess Billings Clinical Research Division
Billings, Montana, United States, 59101
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
United States, North Dakota
Meritcare Neuroscience Clinic
Fargo, North Dakota, United States, 58103
United States, Ohio
Neurology and Neuroscience Assoc.,INC
Akron, Ohio, United States, 44302
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Ohio State University
Columbus, Ohio, United States, 43221
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
University Of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Neurology Specialists of Dallas, PA
Dallas, Texas, United States, 75231
Maxine Mesinger MS Clinic/ Baylor College of Medicine
Houston, Texas, United States, 77030
Neurology Clinic of San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Holy Family MS Center
Spokane, Washington, United States, 99208
Neurology and Neurosurgery Associates of Tacoma, Inc., P.S.
Tacoma, Washington, United States, 98405
United States, Wisconsin
St. Luke's Medical Center/Center for Neurological Disorders
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Genentech, Inc.
Study Director: Craig Smith, M.D. Genentech, Inc.

Publications of Results: Identifier: NCT00097188     History of Changes
Other Study ID Numbers: U2787g
First Posted: November 19, 2004    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: February 2014

Keywords provided by Genentech, Inc.:
Relapsing remitting multiple sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents