- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02322723
Real Life Evaluation of Rheumatoid Arthritis Patients in Israel Treated With HUMIRA (ORIENT)
17. februar 2016 opdateret af: AbbVie
In Israel, data is lacking regarding the long-term effectiveness of Adalimumab in outpatient real life setting.
Moreover, the association between long-term effectiveness of Adalimumab and patients' functional status as well as cultural aspects of sick leaves and visits to physician's clinics has not been demonstrated in this population.
This study will collect the required data in real life settings.
Studieoversigt
Status
Trukket tilbage
Betingelser
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 til 99 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
moderately to severely active Rheumatoid Arthritis patients
Beskrivelse
Inclusion Criteria:
- Patient is eligible to Adalimumab treatment according to the Israeli National Health Basket and for whom a decision of initiating Adalimumab has already been taken. Patients that are naïve to Adalimumab therapy, that have been prescribed adalimumab in accordance to physician's clinical decision and according to local guidelines, up to 30 days prior to screening.
- Patient has performed tuberculosis (TB) screening and treatment according to national guidelines for TB screening prior to anti Tumor Necrosis Factor (anti-TNF) treatment.
- Patient has been diagnosed with Rheumatoid Arthritis (RA) and has disease duration < 3 years.
- Patient has moderately to severely active RA defined by Disease Activity Score (DAS) (moderately (3.2 ≤ DAS ≤ 5.1) severely (DAS ≥5.1))
- Patient is able to sign written informed consent.
- Patient is treated with Methotrexate (MTX) alone or in combination with other Disease Modifying Antirheumatic Drugs (DMARDs)
- Patient might have been treated with another anti-TNF inhibitor agent if discontinued due to secondary loss of efficacy or side effects.
Exclusion Criteria:
- Patient with known hypersensitivity to Adalimumab, or any of its components.
- Patients suffering from serious infection, latent TB or other conditions prohibiting the use of Adalimumab.
- Patient had previous non-response to an anti-TNF agent.
- Patients currently treated with other biologic therapy.
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 |
---|
Moderately to severely active RA patients
Moderately to severely active RA patients aged 18 years or older, both male and female
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Proportion of patients who reached clinical response at 6 months
Tidsramme: At 6 months
|
Proportion of patients who reached Disease Activity Score (DAS)-28 of less than 2.6 or a good DAS response compared to the score on Day 0.
|
At 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Proportion of patients who reached clinical response at 24 months
Tidsramme: At 24 months
|
Proportion of patients who reached Disease Activity Score (DAS)-28 of less than 2.6 or a good DAS response compared to the score on Day 0.
|
At 24 months
|
Change in patient's functional status
Tidsramme: Up to 24 months
|
Proportion of patients reaching HAQ <= 0.5
|
Up to 24 months
|
Change in frequency of sick leave episodes
Tidsramme: Up to 24 months
|
Change in frequency of sick leave episodes
|
Up to 24 months
|
Change in frequency of outpatient clinic visits
Tidsramme: Up to 24 months
|
Change in frequency of outpatient clinic visits
|
Up to 24 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Dina Meyuhas, PhD, AbbVie
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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. februar 2016
Primær færdiggørelse (Forventet)
1. februar 2020
Studieafslutning (Forventet)
1. februar 2020
Datoer for studieregistrering
Først indsendt
19. december 2014
Først indsendt, der opfyldte QC-kriterier
19. december 2014
Først opslået (Skøn)
23. december 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. februar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. februar 2016
Sidst verificeret
1. februar 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P13-987
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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