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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

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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

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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Sponsors and Collaborators
Genentech, Inc.
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Study Director: Craig Smith, M.D. Genentech, Inc.
Publications of Results:
Layout table for additonal information Identifier: NCT00097188    
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:
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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, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents