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

28. februar 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Multipel sclerose

Intervention / Behandling

Medicin: rituximab

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

104

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
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.

Sekundære resultatmål

Resultatmål
To evaluate the efficacy of rituximab compared with placebo.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Genentech, Inc.

Efterforskere

Studieleder: Craig Smith, M.D., Genentech, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2004

Studieafslutning (Faktiske)

1. december 2006

Datoer for studieregistrering

Først indsendt

18. november 2004

Først indsendt, der opfyldte QC-kriterier