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. mai 2018 oppdatert av: 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.
Studieoversikt
Studietype
Observasjonsmessig
Registrering (Faktiske)
140
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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Aalst, Belgia, 9300
- ASZ Aalst
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Assebroek, Belgia, 8310
- AZ Sint Lucas Brugge
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Brugge, Belgia, 8000
- AZ Sint Jan
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Bruxelles, Belgia, 1070
- Hospital Erasme; Neurologie
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Bruxelles, Belgia, 1050
- HIS (Etterbeek Ixelles)
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Bruxelles, Belgia, 1000
- CHU St Pierre (César de Paepe)
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Dendermonde, Belgia, 9200
- AZ Sint Blasius (Dendermonde)
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Edegem, Belgia, 2650
- UZ Antwerpen
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Genk, Belgia, 3600
- ReumaClinic
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Genk, Belgia, 3600
- Reumacentrum Genk
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Gilly (Charleroi), Belgia, 6000
- GHdC Site Saint-Joseph
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Kortrijk, Belgia, 8500
- AZ Groeninge
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Liège, Belgia, 4000
- CHU Sart-Tilman
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Lokeren, Belgia, 9160
- Private practice
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Mont-godinne, Belgia, 5530
- CHU UCL Mont-Godinne
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Oostende, Belgia, 8400
- AZ Damiaan
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Oudenaarde, Belgia, 9700
- AZ Oudenaarde
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Sijsele, Belgia, 8340
- AZ Alma vzw (Sijsele)
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Westmalle, Belgia, 2390
- AZ Sint Jozef Malle
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Wilrijk, Belgia, 2610
- Sint Augustinus Wilrijk
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Zoersel, Belgia, 2980
- CVBA Diagnosecentrum Voorkempen
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Luxembourg, Luxembourg, 2540
- Höpital Kirchberg; Rheumatology
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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 og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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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.
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Participants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl)
Tidsramme: Up to Week 24
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Up to Week 24
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Correlation Coefficient Between CDAI and simplified disease activity index (SDAI) and Between SDAI and DAS28-ESR
Tidsramme: Up to Week 24
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Up to Week 24
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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
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Up to Week 24
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Time to achieve low disease activity (LDA) using DAS28 (<= 3.2), CDAl (<=10.0) and SDAI (<=11 .0)
Tidsramme: Up to week 24
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Up to week 24
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Percentage of participants to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)
Tidsramme: Up to Week 24
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Up to Week 24
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Time to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)
Tidsramme: Up to Week 24
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Up to Week 24
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Percentage of participants to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)
Tidsramme: Up to Week 24
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Up to Week 24
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Time to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)
Tidsramme: Up to Week 24
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Up to Week 24
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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
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Up to Week 24
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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
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Up to Week 24
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Change from baseline in total tender joint count (TJC)
Tidsramme: Up to Week 24
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Up to Week 24
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Change from baseline in total swollen joint count (SJC)
Tidsramme: Up to Week 24
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Up to Week 24
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Percentage of participants having TJC <=1
Tidsramme: Up to Week 24
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Up to Week 24
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Percentage of participants having SJC <=1
Tidsramme: Up to Week 24
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Up to Week 24
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Patient Global Assessment of disease activity visual analogue scale (VAS) score
Tidsramme: Up to Week 24
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Up to Week 24
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Physician Global Assessment of disease activity VAS score
Tidsramme: Up to Week 24
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Up to Week 24
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Percentage of participants having CRP <=1mg/dl
Tidsramme: Up to Week 24
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Up to Week 24
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Health Assessment Questionnaire Disability Index (HAQ-DI)
Tidsramme: Up to Week 24
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Up to Week 24
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EQ-5D-5L Health Questionnaire (EuroQoL)
Tidsramme: Up to Week 24
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Up to Week 24
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Morisky Medication-Taking Adherence Scale (MMAS)
Tidsramme: Up to Week 24
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Up to Week 24
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Percentage of participants using TCZ in monotherapy
Tidsramme: At baseline
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At baseline
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Percentage of participants using TCZ in combination with disease-modifying antirheumatic drug's (DMARD's)
Tidsramme: At baseline
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At baseline
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Percentage of participants presenting a high inflammation (DAS28-ESR >5.1)
Tidsramme: At baseline
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At baseline
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
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 (Faktiske)
31. oktober 2015
Primær fullføring (Faktiske)
23. oktober 2017
Studiet fullført (Faktiske)
23. oktober 2017
Datoer for studieregistrering
Først innsendt
16. september 2015
Først innsendt som oppfylte QC-kriteriene
16. september 2015
Først lagt ut (Anslag)
17. september 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. mai 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. mai 2018
Sist bekreftet
1. mai 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ML29691
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