Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521)

29. maj 2015 opdateret af: Merck Sharp & Dohme LLC

Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Rheumatoid Arthritis During Different Forms of Anti-Tumor Necrosis-Alpha Treatments.

This 14-week study will observe the gene expression of certain immune cells in patients with rheumatoid arthritis who receive etanercept, infliximab, and adalimumab. Patients at the National Institute of Rheumatology and Physiotherapy, Budapest, who are already scheduled to receive an anti-TNF agent will be asked to participate in this study. Patients will receive their treatment (etanercept, infliximab, or adalimumab) as scheduled, and have blood samples collected during the study and analyzed by the laboratory. Patient's response to their treatment will also be studied based on x-rays and other examinations.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Only patients who - regardless of this study - are scheduled and permitted to receive anti-TNF-alpha treatment because of their RA will be asked to participate. No patient will be recruited only for the sake of the study. The prescribing physicians will not be influenced by the study as to what form of anti-TNF-alpha therapy they should select.

Undersøgelsestype

Observationel

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Subjects will be recruited from a single center at the National Institute of Rheumatology and Physiotherapy, Budapest, the largest center for biological therapy in Hungary. Subjects will be patients who are scheduled and permitted to receive anti-TNF-alpha treatment due to their rheumatoid arthritis.

Beskrivelse

Inclusion Criteria:

  • Must have active RA (DAS28 >5.1)
  • Must have x-ray evidence of an erosive disease,
  • Must be eligible for but have never received any anti-TNF treatment,
  • Must fulfill the 1987 criteria of the American College of Rheumatology classification criteria for a diagnosis of RA, for at least 3 months,
  • Must have failed standard therapy (methotrexate or leflunomide).

Exclusion Criteria:

  • Must not be a women who is pregnant or breastfeeding,
  • Must not have a history of any malignancy,
  • Must not have an active infection,
  • Must not be prone to infection,
  • Must not have tuberculosis, hepatitis B, hepatitis C, or HIV,
  • Must not have septic arthritis of a native prosthetic joint within the last 12 months,
  • Must not have NYHA grade 3 or 4 heart failure,
  • Must not have a history of demyelinating disease or systemic lupus erythematosis.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
ETA
RA patients who were scheduled to receive etanercept 50 mg subcutaneously once weekly
Medicin: etanercept
etanercept 50 mg subcutaneously once weekly
Andre navne:
  • Enbrel®
IFX
RA patients who were scheduled to receive infliximab 3 mg/kg IV at Weeks 0, 2, and 6
Medicin: infliximab
infliximab 3 mg/kg IV at Weeks 0, 2, and 6
Andre navne:
  • Remicade®, SCH 215596
ADA
RA patients who were scheduled to receive adalimumab 40 mg subcutaneously biweekly
Medicin: adalimumab
adalimumab 40 mg subcutaneously biweekly
Andre navne:
  • Humira®
non-diseased controls
Healthy individuals who contributed their RNA/cDNA samples prior to the study and for whom ethical approval has already been obtained.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Gene expression (under- or overexpression) in the peripheral blood mononuclear cells
Tidsramme: Weeks 0, 4, and 14.
Weeks 0, 4, and 14.

Sekundære resultatmål

Resultatmål
Tidsramme
Disease Activity measured by DAS28
Tidsramme: Weeks 0 and 14
Weeks 0 and 14

Samarbejdspartnere og efterforskere

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

Sponsor

Merck Sharp & Dohme LLC

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. september 2008

Primær færdiggørelse (Forventet)

1. juli 2009

Studieafslutning (Forventet)

1. juli 2009

Datoer for studieregistrering

Først indsendt

25. juli 2008

Først indsendt, der opfyldte QC-kriterier

28. juli 2008

Først opslået (Skøn)

29. juli 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. juni 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2015

Sidst verificeret

1. maj 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P05521

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 .

Kliniske forsøg med Rheumatoid arthritis

Kliniske forsøg med etanercept

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mexico

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner