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

Completed · Phase 2

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00097188

Run by

Genentech, Inc.

People needed

104

Starts

2004-12-01

Expected to finish

2006-12-01

Last updated by the study team

2014-03-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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