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

February 28, 2014 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
To evaluate the efficacy of rituximab compared with placebo.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Craig Smith, M.D., Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

November 18, 2004

First Submitted That Met QC Criteria

November 18, 2004

First Posted (Estimate)

November 19, 2004

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

February 28, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U2787g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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