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Multiple SclerosisPhase 2NCT00097188

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

A Phase 2 study testing rituximab in people with Multiple Sclerosis, run by Genentech, Inc. at 31 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
rituximab
How many people
104 participants
Where
31 sitesUnited States
Study dates
Dec 2004to Dec 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 44Show fewer
  • 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)

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites

  • Neurology and Neuroscience Assoc.,INC

    Akron, Ohio, 44302

  • Albany Medical Center

    Albany, New York, 12208

  • MS Center Of Atlanta

    Atlanta, Georgia, 30327

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • University of Maryland Hospital MS Center

    Baltimore, Maryland, 21201

  • Deaconess Billings Clinical Research Division

    Billings, Montana, 59101

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43221

  • Neurology Specialists of Dallas, PA

    Dallas, Texas, 75231

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Meritcare Neuroscience Clinic

    Fargo, North Dakota, 58103

  • Michigan Institute For Neurological Disorders

    Farmington Hills, Michigan, 48334

  • Maxine Mesinger MS Clinic/ Baylor College of Medicine

    Houston, Texas, 77030

  • University Of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Loma Linda University

    Loma Linda, California, 92354

  • Kentucky Neuroscience Research

    Louisville, Kentucky, 40202

  • Neurology Associates, P.A.

    Maitland, Florida, 32751

  • Multiple Sclerosis Center of Brevard

    Melbourne, Florida, 32940

  • St. Luke's Medical Center/Center for Neurological Disorders

    Milwaukee, Wisconsin, 53215

  • Sutter Gould Medical Foundation

    Modesto, California, 95355

  • Neurological Services Of Orlando

    Orlando, Florida, 32806

  • University Of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

  • Phoenix Neurological Associates

    Phoenix, Arizona, 85006

  • Neurological Associates

    Pompano Beach, Florida, 33060

  • University Of California At Davis

    Sacramento, California, 95817

  • Neurology Clinic of San Antonio

    San Antonio, Texas, 78229

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Holy Family MS Center

    Spokane, Washington, 99208

  • Neurology and Neurosurgery Associates of Tacoma, Inc., P.S.

    Tacoma, Washington, 98405

  • MS Center of Vero Beach

    Vero Beach, Florida, 32960

  • Neurological Research Institute Of East Bay

    Walnut Creek, California, 94596

Other trials in United States

About this study

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

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.

Being tested
rituximab
Keywords
Relapsing remitting multiple sclerosis
Medical subject headings
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  1. To evaluate the efficacy of rituximab compared with placebo.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2004 (estimated)
  2. Study startDec 2004
  3. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00097188
Sponsor's protocol ID
U2787g
Status last verified
Feb 2014
First submitted
18 Nov 2004
Last updated
4 Mar 2014
Results posted
No

Publications

  • 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.

    PubMed 18272891

  • Smith 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.

    PubMed 19491632

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rituximab in people with Multiple Sclerosis, run by Genentech, Inc. at 31 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00097188, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.

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