- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01617005
A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)
7. oktober 2016 opdateret af: Hoffmann-La Roche
Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD
This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs.
Data will be collected from each eligible participant initiating tocilizumab treatment over 6 months.
Studieoversigt
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
50
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Podgorica, Montenegro, 81000
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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
Participants with RA and an inadequate response to non-biologic DMARDs.
Beskrivelse
Inclusion Criteria:
- Moderate to severe active RA (European League Against Rheumatism [EULAR] criteria)
- Inadequate response to DMARDs or tumor necrosis factor (TNF) antagonists
- Initiating treatment with tocilizumab according to SPC
Exclusion Criteria:
- Rheumatic autoimmune disease other than RA
- Prior history or current inflammatory joint disease other than RA
- Previous treatment with any biological drug used in the treatment of RA
- Previous treatment with tocilizumab
- Any contraindication to treatment with tocilizumab
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- Pregnant women or nursing (breastfeeding) mothers
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Tocilizumab in Moderate to Severe Active RA
Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), will be observed.
The choice of therapy will be based exclusively on the medical decision of the treating physician before study enrollment.
The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.
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Participants will receive tocilizumab treatment according to effective official SPC.
The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Tidsramme: Baseline up to Week 24
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
AEs include both SAEs as well as non-serious AEs.
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Baseline up to Week 24
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria
Tidsramme: Baseline, Week 24
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EULAR response was based on 28-joint disease activity score (DAS28).
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) in DAS28 score and the level of disease activity reached (absolute DAS28 score).
Good responders had a CFB greater than (>) 1.2 with a DAS28 score less than or equal to (<=) 3.2; moderate responders had a CFB >1.2 with a DAS28 score >3.2 to <= 5.1 or a change from baseline >0.6 to <= 1.2 with a DAS28 score <= 5.1; non-responders had a CFB <=0.6 or CFB >0.6 to <=1.2 with DAS28 >5.1.
Number of participants who achieved EULAR good response and EULAR moderate response were reported.
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Baseline, Week 24
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Number of Participants Who Discontinued Treatment Due to Lack of Efficacy
Tidsramme: Baseline up to Week 24
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Baseline up to Week 24
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Time to Discontinuation Due to Lack of Efficacy
Tidsramme: Baseline up to Week 24
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Baseline up to Week 24
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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
Studiestart
1. maj 2012
Primær færdiggørelse (Faktiske)
1. september 2014
Studieafslutning (Faktiske)
1. september 2014
Datoer for studieregistrering
Først indsendt
8. juni 2012
Først indsendt, der opfyldte QC-kriterier
11. juni 2012
Først opslået (Skøn)
12. juni 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. december 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. oktober 2016
Sidst verificeret
1. oktober 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ML25699
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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Kliniske forsøg med Tocilizumab
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University of ChicagoAktiv, ikke rekrutterende
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University of ChicagoRekruttering
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Reade Rheumatology Research InstituteZonMw: The Netherlands Organisation for Health Research and DevelopmentRekrutteringRheumatoid arthritisHolland
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Memorial Sloan Kettering Cancer CenterAfsluttetCOVID-19Forenede Stater
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University of ChicagoAfsluttet
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Assistance Publique - Hôpitaux de ParisUkendtCoronavirusinfektionFrankrig
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Università Politecnica delle MarcheAzienda Ospedaliera Ospedali Riuniti Marche NordUkendt
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Hospital of PratoUkendtKæmpecelle arteritisItalien
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CelltrionIkke rekrutterer endnu
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Hoffmann-La RocheAfsluttetCOVID-19Spanien, Tyskland, Forenede Stater, Brasilien, Italien, Frankrig, Grækenland, Kroatien, Polen, Sydafrika, Det Forenede Kongerige