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

28 febbraio 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Sclerosi multipla

Intervento / Trattamento

Droga: rituximab

Tipo di studio

Interventistico

Iscrizione (Effettivo)

104

Fase

Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 55 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
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.

Misure di risultato secondarie

Misura del risultato
To evaluate the efficacy of rituximab compared with placebo.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Genentech, Inc.

Investigatori

Direttore dello studio: Craig Smith, M.D., Genentech, Inc.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2004

Completamento dello studio (Effettivo)

1 dicembre 2006

Date di iscrizione allo studio

Primo inviato

18 novembre 2004

Primo inviato che soddisfa i criteri di controllo qualità