A Study to Evaluate Rituximab in Adults With Relapsing Remitting Multiple Sclerosis
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
1 other identifier
interventional
104
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-sclerosis
Started Dec 2004
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2004
CompletedFirst Posted
Study publicly available on registry
November 19, 2004
CompletedStudy Start
First participant enrolled
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedMarch 4, 2014
February 1, 2014
November 18, 2004
February 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (1)
To evaluate the efficacy of rituximab compared with placebo.
Interventions
Eligibility Criteria
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)
- +29 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (31)
Phoenix Neurological Associates
Phoenix, Arizona, 85006, United States
Loma Linda University
Loma Linda, California, 92354, United States
Sutter Gould Medical Foundation
Modesto, California, 95355, United States
University Of California At Davis
Sacramento, California, 95817, United States
Neurological Research Institute Of East Bay
Walnut Creek, California, 94596, United States
Neurology Associates, P.A.
Maitland, Florida, 32751, United States
Multiple Sclerosis Center of Brevard
Melbourne, Florida, 32940, United States
Neurological Services Of Orlando
Orlando, Florida, 32806, United States
Neurological Associates
Pompano Beach, Florida, 33060, United States
MS Center of Vero Beach
Vero Beach, Florida, 32960, United States
MS Center Of Atlanta
Atlanta, Georgia, 30327, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
University Of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Kentucky Neuroscience Research
Louisville, Kentucky, 40202, United States
University of Maryland Hospital MS Center
Baltimore, Maryland, 21201, United States
Michigan Institute For Neurological Disorders
Farmington Hills, Michigan, 48334, United States
Deaconess Billings Clinical Research Division
Billings, Montana, 59101, United States
Albany Medical Center
Albany, New York, 12208, United States
Meritcare Neuroscience Clinic
Fargo, North Dakota, 58103, United States
Neurology and Neuroscience Assoc.,INC
Akron, Ohio, 44302, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43221, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
University Of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
Neurology Specialists of Dallas, PA
Dallas, Texas, 75231, United States
Maxine Mesinger MS Clinic/ Baylor College of Medicine
Houston, Texas, 77030, United States
Neurology Clinic of San Antonio
San Antonio, Texas, 78229, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Holy Family MS Center
Spokane, Washington, 99208, United States
Neurology and Neurosurgery Associates of Tacoma, Inc., P.S.
Tacoma, Washington, 98405, United States
St. Luke's Medical Center/Center for Neurological Disorders
Milwaukee, Wisconsin, 53215, United States
Related Publications (2)
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.
PMID: 18272891RESULTSmith 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.
PMID: 19491632RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Craig Smith, M.D.
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 18, 2004
First Posted
November 19, 2004
Study Start
December 1, 2004
Study Completion
December 1, 2006
Last Updated
March 4, 2014
Record last verified: 2014-02