- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00097188
A Study to Evaluate Rituximab in Adults With Relapsing Remitting Multiple Sclerosis
28. februar 2014 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
104
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Arizona
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Phoenix, Arizona, Forente stater, 85006
- Phoenix Neurological Associates
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California
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Loma Linda, California, Forente stater, 92354
- Loma Linda University
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Modesto, California, Forente stater, 95355
- Sutter Gould Medical Foundation
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Sacramento, California, Forente stater, 95817
- University of California at Davis
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Walnut Creek, California, Forente stater, 94596
- Neurological Research Institute Of East Bay
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Florida
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Maitland, Florida, Forente stater, 32751
- Neurology Associates, P.A.
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Melbourne, Florida, Forente stater, 32940
- Multiple Sclerosis Center of Brevard
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Orlando, Florida, Forente stater, 32806
- Neurological Services of Orlando
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Pompano Beach, Florida, Forente stater, 33060
- Neurological Associates
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Vero Beach, Florida, Forente stater, 32960
- MS Center of Vero Beach
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Georgia
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Atlanta, Georgia, Forente stater, 30327
- MS Center of Atlanta
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Augusta, Georgia, Forente stater, 30912
- Medical College of Georgia
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- University of Kansas Medical Center
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Kentucky
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Louisville, Kentucky, Forente stater, 40202
- Kentucky Neuroscience Research
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- University of Maryland Hospital MS Center
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Michigan
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Farmington Hills, Michigan, Forente stater, 48334
- Michigan Institute for Neurological Disorders
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Montana
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Billings, Montana, Forente stater, 59101
- Deaconess Billings Clinical Research Division
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New York
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Albany, New York, Forente stater, 12208
- Albany Medical Center
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North Dakota
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Fargo, North Dakota, Forente stater, 58103
- Meritcare Neuroscience Clinic
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Ohio
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Akron, Ohio, Forente stater, 44302
- Neurology and Neuroscience Assoc.,INC
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Cleveland, Ohio, Forente stater, 44195
- The Cleveland Clinic Foundation
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Columbus, Ohio, Forente stater, 43221
- The Ohio State University
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Pennsylvania
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Danville, Pennsylvania, Forente stater, 17822
- Geisinger Medical Center
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Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania Medical Center
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Texas
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Dallas, Texas, Forente stater, 75231
- Neurology Specialists of Dallas, PA
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Houston, Texas, Forente stater, 77030
- Maxine Mesinger MS Clinic/ Baylor College of Medicine
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San Antonio, Texas, Forente stater, 78229
- Neurology Clinic of San Antonio
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Washington
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Seattle, Washington, Forente stater, 98101
- Virginia Mason Medical Center
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Spokane, Washington, Forente stater, 99208
- Holy Family MS Center
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Tacoma, Washington, Forente stater, 98405
- Neurology and Neurosurgery Associates of Tacoma, Inc., P.S.
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53215
- St. Luke's Medical Center/Center for Neurological Disorders
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 55 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Hva måler studien?
Primære resultatmål
Resultatmål |
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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 |
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To evaluate the efficacy of rituximab compared with placebo.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Craig Smith, M.D., Genentech, Inc.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2004
Studiet fullført (Faktiske)
1. desember 2006
Datoer for studieregistrering
Først innsendt
18. november 2004
Først innsendt som oppfylte QC-kriteriene
18. november 2004
Først lagt ut (Anslag)
19. november 2004
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
4. mars 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. februar 2014
Sist bekreftet
1. februar 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Sykdommer i nervesystemet
- Sykdommer i immunsystemet
- Demyeliniserende autoimmune sykdommer, CNS
- Autoimmune sykdommer i nervesystemet
- Demyeliniserende sykdommer
- Autoimmune sykdommer
- Multippel sklerose
- Sklerose
- Multippel sklerose, tilbakefallende-remitterende
- Fysiologiske effekter av legemidler
- Antirevmatiske midler
- Antineoplastiske midler
- Immunologiske faktorer
- Antineoplastiske midler, immunologiske
- Rituximab
Andre studie-ID-numre
- U2787g
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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