- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00123149
Open-Label Extension Safety Study of PROCRIT in Patients With Anemia of Chronic Disease Due to Rheumatoid Arthritis
19. september 2016 opdateret af: Ortho Biotech Products, L.P.
An Open-Label (OL) Extension Study to Assess Safety of PROCRIT (Epoetin Alfa) in Patients With Anemia of Chronic Disease (ACD) Due to Rheumatoid Arthritis (RA)
The purpose of this study is to evaluate the long-term safety profile of epoetin alfa in patients with anemia of chronic disease due to rheumatoid arthritis
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Epoetin alfa is an analogue of erythropoetin, a hormone secreted by kidneys known to stimulate red blood cell production.
Although epoetin alfa has been known to be effective in treatment of anemia associated with chronic kidney disease, information on its effectiveness and long-term safety for treatment of anemia associated with rheumatoid arthritis is limited.
This 35-week safety study is an extension of a 20-week, prospective, randomized, double-blind, placebo-controlled, multi-center study that investigates effectiveness of epoetin alfa in patients with anemia of chronic disease due to rheumatoid arthritis.
The study hypothesis is that there will be no long-term safety concerns of epoetin alfa administered once every two weeks in rheumatoid arthritis patients with anemia of chronic disease.
Patients will receive epoetin alfa injections (40,000 units) under their skin once every 2 weeks for up to 31 weeks.
Doses may be adjusted depending on the patients' hemoglobin level up to the maximum of 60,000 units once every 2 weeks or 40,000 units once weekly.
Undersøgelsestype
Interventionel
Fase
- Fase 2
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 99 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients must have signed an informed consent
- Women must be postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control, or have a negative serum pregnancy test at Week 1 of the study
- Women must not be breast feeding during this study period
- Patients must have completed the double-blind (DB) study (PR03-33-055) without missing more than 4 study visits and have hemoglobin level of less than or equal to 12.9 g/dL at Week 20 of the DB study
Exclusion Criteria:
- Uncontrolled hypertension
- Elective surgery, including joint replacement, anticipated to require transfusion during the extension study period
- Thromboembolic event during the double-blind study including acute myocardial infarction, Cerebrovascular accident and/or transient ischemic attack
- Deep vein thrombosis and/or pulmonary embolism
- Uncontrolled psychiatric disease or other co-morbid disease that have developed or worsened since enrollment to the double-blind study
- Planning to be enrolled in any other clinical trial during the course of this study
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
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
Incidence of adverse events during the study period of up to 35 weeks; blood pressure and blood counts measured every 2 weeks up to 35 weeks. For patients who have dose increased to 40,000 units once weekly, hemoglobin levels will be monitored weekly
|
Sekundære resultatmål
Resultatmål |
---|
Hemoglobin level measured every two weeks up to 35 weeks; for patients who are receiving 40,000 U QW dosing, Hb levels will be monitored weekly
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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
Studieafslutning (Forventet)
1. oktober 2007
Datoer for studieregistrering
Først indsendt
19. juli 2005
Først indsendt, der opfyldte QC-kriterier
19. juli 2005
Først opslået (Skøn)
22. juli 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. september 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. september 2016
Sidst verificeret
1. juli 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR002461
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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Janssen Research & Development, LLCTrukket tilbageAktiv reumatoid arthritis; Rheumatoid arthritis
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Hamad Medical CorporationUkendtRHEUMATOID ARTHRITISQatar
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Healthcare Homoeo Charitable SocietyUkendtRheumatoid arthritis.Indien
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Federal University of São PauloAfsluttetRheumatoid arthritis.Brasilien
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Richard Burt, MDAfsluttet
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Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloUkendt- Rheumatoid arthritisBrasilien
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Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
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Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
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University of SalfordAfsluttetRheumatoid arthritis | Håndslidgigt | Inflammatorisk arthritisDet Forenede Kongerige
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Link America, Inc.AfsluttetSlidgigt | Rheumatoid arthritis | Post-traumatisk arthritisForenede Stater
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Hospital de Clinicas de Porto AlegreOswaldo Cruz Foundation; Rio Grande do Sul State Health Department - SES...AfsluttetSammenligning af effektiviteten af to formuleringer af epoetin hos patienter, der gennemgår hæmodialyse
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MegalabsAzidus LaboratoriesIkke rekrutterer endnuAnæmi af kronisk nyresygdomUruguay
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M.D. Anderson Cancer CenterAfsluttet
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Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech, Inc.Afsluttet
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Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.Afsluttet
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Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.Afsluttet
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Johnson & Johnson Pharmaceutical Research & Development...Afsluttet
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Hoffmann-La RocheAfsluttet
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Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.AfsluttetAnæmi | Surgery, Arthroscopy