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

An Observational Study to Evaluate the Clinical Effectiveness, Quality of Life, Safety and Tolerability of Tocilizumab (TCZ) in Patients With Rheumatoid Arthritis (RA) in Daily Clinical Practice

10. maj 2018 opdateret af: Hoffmann-La Roche

A PROSPECTIVE, NON-INTERVENTIONAL STUDY TO EVALUATE THE CLINICAL EFFECTIVENESS, THE CONSISTENCY OF EVALUATION SCORES, QUALITY OF LIFE, SAFETY AND TOLERABILITY OF TOCILIZUMAB SUBCUTANEOUS IN PATIENTS WITH RHEUMATOID ARTHRITIS IN DAILY CLINICAL PRACTICE

This observational trial will evaluate the effectiveness, the consistency of evaluation scores, quality of life, safety and tolerability of TCZ administered subcutaneously (SC) in participants with RA in daily clinical practice.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

140

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Aalst, Belgien, 9300
        • ASZ Aalst
      • Assebroek, Belgien, 8310
        • AZ Sint Lucas Brugge
      • Brugge, Belgien, 8000
        • AZ Sint Jan
      • Bruxelles, Belgien, 1070
        • Hospital Erasme; Neurologie
      • Bruxelles, Belgien, 1050
        • HIS (Etterbeek Ixelles)
      • Bruxelles, Belgien, 1000
        • CHU St Pierre (César de Paepe)
      • Dendermonde, Belgien, 9200
        • AZ Sint Blasius (Dendermonde)
      • Edegem, Belgien, 2650
        • UZ Antwerpen
      • Genk, Belgien, 3600
        • ReumaClinic
      • Genk, Belgien, 3600
        • Reumacentrum Genk
      • Gilly (Charleroi), Belgien, 6000
        • GHdC Site Saint-Joseph
      • Kortrijk, Belgien, 8500
        • AZ Groeninge
      • Liège, Belgien, 4000
        • CHU Sart-Tilman
      • Lokeren, Belgien, 9160
        • Private Practice
      • Mont-godinne, Belgien, 5530
        • CHU UCL Mont-Godinne
      • Oostende, Belgien, 8400
        • AZ Damiaan
      • Oudenaarde, Belgien, 9700
        • AZ Oudenaarde
      • Sijsele, Belgien, 8340
        • AZ Alma vzw (Sijsele)
      • Westmalle, Belgien, 2390
        • AZ Sint Jozef Malle
      • Wilrijk, Belgien, 2610
        • Sint Augustinus Wilrijk
      • Zoersel, Belgien, 2980
        • CVBA Diagnosecentrum Voorkempen
  • Luxembourg
      • Luxembourg, Luxembourg, 2540
        • Höpital Kirchberg; Rheumatology

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

Participant with a diagnosis of moderate to severe RA defined as DAS28 more than or equal to (>=) 3.7, naïve to TCZ and in whom the treating physician has made the decision to commence TCZ SC in accordance with the label and reimbursement criteria

Beskrivelse

Inclusion Criteria:

  • Participants naive to TCZ or who have received TCZ SC treatment within 8 weeks prior to the enrolment visit can be included
  • Participants in whom the treating physician has made the decision to commence TCZ SC in accordance with the label and reimbursement criteria

Exclusion Criteria:

  • Participants who have received TCZ >8 weeks prior to the enrolment visit
  • Participants who have previously received TCZ SC
  • Participants who have received treatment with any investigational agent within 4 weeks before starting treatment with TCZ SC

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
Rheumatoid Arthritis participants treated with Tocilizumab SC
Participants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months.
Medicin: Tocilizumab
Participants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months.
Andre navne:
  • RoACTEMRA

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl)
Tidsramme: Up to Week 24
Up to Week 24

Sekundære resultatmål

Resultatmål
Tidsramme
Correlation Coefficient Between CDAI and simplified disease activity index (SDAI) and Between SDAI and DAS28-ESR
Tidsramme: Up to Week 24
Up to Week 24
Percentage of participants to achieve low disease activity (LDA) using DAS28 (less than or equal to [<=] 3.2), CDAl (<=10.0) and SDAI (<=11 .0)
Tidsramme: Up to Week 24
Up to Week 24
Time to achieve low disease activity (LDA) using DAS28 (<= 3.2), CDAl (<=10.0) and SDAI (<=11 .0)
Tidsramme: Up to week 24
Up to week 24
Percentage of participants to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)
Tidsramme: Up to Week 24
Up to Week 24
Time to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)
Tidsramme: Up to Week 24
Up to Week 24
Percentage of participants to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)
Tidsramme: Up to Week 24
Up to Week 24
Time to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)
Tidsramme: Up to Week 24
Up to Week 24
Percentage of participants to achieve a major and minor improvement in CDAl (more than or equal to [>=]13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively)
Tidsramme: Up to Week 24
Up to Week 24
Time to achieve a major and minor improvement in CDAl (>=13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively)
Tidsramme: Up to Week 24
Up to Week 24
Change from baseline in total tender joint count (TJC)
Tidsramme: Up to Week 24
Up to Week 24
Change from baseline in total swollen joint count (SJC)
Tidsramme: Up to Week 24
Up to Week 24
Percentage of participants having TJC <=1
Tidsramme: Up to Week 24
Up to Week 24
Percentage of participants having SJC <=1
Tidsramme: Up to Week 24
Up to Week 24
Patient Global Assessment of disease activity visual analogue scale (VAS) score
Tidsramme: Up to Week 24
Up to Week 24
Physician Global Assessment of disease activity VAS score
Tidsramme: Up to Week 24
Up to Week 24
Percentage of participants having CRP <=1mg/dl
Tidsramme: Up to Week 24
Up to Week 24
Health Assessment Questionnaire Disability Index (HAQ-DI)
Tidsramme: Up to Week 24
Up to Week 24
EQ-5D-5L Health Questionnaire (EuroQoL)
Tidsramme: Up to Week 24
Up to Week 24
Morisky Medication-Taking Adherence Scale (MMAS)
Tidsramme: Up to Week 24
Up to Week 24
Percentage of participants using TCZ in monotherapy
Tidsramme: At baseline
At baseline
Percentage of participants using TCZ in combination with disease-modifying antirheumatic drug's (DMARD's)
Tidsramme: At baseline
At baseline
Percentage of participants presenting a high inflammation (DAS28-ESR >5.1)
Tidsramme: At baseline
At baseline

Samarbejdspartnere og efterforskere

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

Sponsor

Hoffmann-La Roche

Samarbejdspartnere

nv Roche sa

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 (Faktiske)

31. oktober 2015

Primær færdiggørelse (Faktiske)

23. oktober 2017

Studieafslutning (Faktiske)

23. oktober 2017

Datoer for studieregistrering

Først indsendt

16. september 2015

Først indsendt, der opfyldte QC-kriterier

16. september 2015

Først opslået (Skøn)

17. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. maj 2018

Sidst verificeret

1. maj 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML29691

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 Tocilizumab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mali

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner