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A Retrospective Chart Review of MabThera (Rituximab) Treatment in Rheumatoid Arthritis (RA) Participants in Australia

1. november 2016 opdateret af: Hoffmann-La Roche

A Retrospective Chart Review of the Use of MabThera (Rituximab) for the Treatment of Rheumatoid Arthritis (RA) in Australian Rheumatology Practice

This is a cross-sectional, observational study examining the factors leading to the therapeutic decision to use MabThera (rituximab) in participants with RA. Routine rheumatology clinical practice data of participants who are being or have been treated with rituximab for RA will be collected and analysed in this chart review.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

167

Kontakter og lokationer

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

Studiesteder

  • Australien
    • Victoria
      • Geelong, Victoria, Australien, 3220

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

Rheumatoid arthritis (RA) participants who have been treated with rituximab

Beskrivelse

Inclusion Criteria:

  • Greater than or equal to (>=) 18 years of age at the time of data collection
  • RA diagnosed by a rheumatologist
  • Treatment with rituximab for RA

Exclusion Criteria:

  • Participants whose primary diagnosis and indication for rituximab treatment is a condition other than RA
  • Participants who have been treated with an experimental agent for RA which is not currently approved for the treatment of RA in Australia

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
Rheumatoid arthritis (RA) participants
Participants who had been treated with rituximab for RA are reviewed retrospectively using chart review from Baseline until and their most recent visit to the rheumatologist prior to the conduct of the chart review.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Factors leading to Therapeutic decision to use rituximab
Tidsramme: Up to end of study (approximately 1 month)
Up to end of study (approximately 1 month)

Sekundære resultatmål

Resultatmål
Tidsramme
Change in Erythrocyte sedimentation rate
Tidsramme: Baseline and most recent visits (approximately 1 month)
Baseline and most recent visits (approximately 1 month)
Change in Immunoglobulin levels
Tidsramme: Baseline and most recent visits (approximately 1 month)
Baseline and most recent visits (approximately 1 month)
Percentage of participants with positive or negative results for rheumatoid factor
Tidsramme: Up to end of study (approximately 1 month)
Up to end of study (approximately 1 month)
Percentage of participants with positive or negative results for anti-cyclic citrullinated peptide antibody
Tidsramme: Up to end of study (approximately 1 month)
Up to end of study (approximately 1 month)
Percentage of participants with positive or negative results for anti-nuclear antibodies
Tidsramme: Up to end of study (approximately 1 month)
Up to end of study (approximately 1 month)
Disease activity score (DAS28)
Tidsramme: At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
Tender joint count (TJC)
Tidsramme: At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
Swollen joint count (SJC)
Tidsramme: At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
Duration of treatment with rituximab
Tidsramme: From first dose to most recent rituximab infusion (approximately 1 month)
From first dose to most recent rituximab infusion (approximately 1 month)
Change in C-reactive protein
Tidsramme: Baseline and most recent visits (approximately 1 month)
Baseline and most recent visits (approximately 1 month)

Samarbejdspartnere og efterforskere

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

Sponsor

Hoffmann-La Roche

Samarbejdspartnere

Roche Products Pty Ltd (Australia)

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. januar 2012

Primær færdiggørelse (Faktiske)

1. februar 2012

Studieafslutning (Faktiske)

1. februar 2012

Datoer for studieregistrering

Først indsendt

11. august 2015

Først indsendt, der opfyldte QC-kriterier

29. september 2015

Først opslået (Skøn)

1. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. november 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. november 2016

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML28321

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

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ireland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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