Study Evaluating the Clinical Remission in Early Aggressive Rheumatoid Arthritis (ARPA)
14. september 2011 opdateret af: Wyeth is now a wholly owned subsidiary of Pfizer
An Observational Study To Evaluate The Clinical Remission In Early Aggressive Rheumatoid Arthritis (Artrite Reumatoide Precoce Aggressiva Italian Study)
This is an observational prospective, multicenter study. The aim of the study is to evaluate how the Italian population of patients are treated with early aggressive RA, defined by the Italian Society of Rheumatology Guidelines, (GIARA Registry Study Group. Clin Exp Rheumatol 2003;21(Suppl. 31):S129-S132), in rheumatologic clinical practice and whether recent scientific evidence or new treatments available to rheumatologists can change their practice in a 2 year follow-up. The observation will primarily focus on the disease activity and clinical remission in patients who are receiving different treatment strategies. The primary goal is to define prevalence of clinical remission, according to the (Disease Activity Score) DAS 28 definition of clinical remission, in patients with early aggressive RA receiving different therapies at 1 year.
Secondary objective are assessment of:
- Prevalence of Remission at the second year
- Disease activity at the first and second year.
- ACR 20%, 50%, 70% response at the first and second year.
- Quality of Life in patients with or without remission at the first and second year
- Safety Evaluations
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
It was expected that approximate 200 patients were enrolled in the study.
Have been enrolled 152 patients.
A Statistical Analysis Plan will contain a detailed description of criteria for valuable patients for analyses and a description of statistical analyses.
In general, all patients who respond inclusion/exclusion criteria at baseline will be considered valuable for the study.
The summaries will include descriptive statistics (mean, standard deviation, sample size) for the continuous parameters, and absolute frequencies and percentages for the remaining categorical parameters.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
152
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Brescia, Italien, 25125
- Pfizer Investigational Site
-
Genova, Italien
- Pfizer Investigational Site
-
Messina, Italien, 98122
- Pfizer Investigational Site
-
Padova, Italien, 35128
- Pfizer Investigational Site
-
Palermo, Italien, 90100
- Pfizer Investigational Site
-
Pavia, Italien, 27100
- Pfizer Investigational Site
-
Siena, Italien, 53100
- Pfizer Investigational Site
-
Torino, Italien, 10128
- Pfizer Investigational Site
-
-
Ancona
-
Jesi, Ancona, Italien, 60035
- Pfizer Investigational Site
-
-
Campania
-
Napoli, Campania, Italien, 80131
- Pfizer Investigational Site
-
-
Ferrara (FE)
-
Ferrara, Ferrara (FE), Italien, 44100
- Pfizer Investigational Site
-
-
GE
-
Arenzano, GE, Italien, 16011
- Pfizer Investigational Site
-
-
Lazio
-
Roma, Lazio, Italien, 00161
- Pfizer Investigational Site
-
-
Puglia
-
Bari, Puglia, Italien, 70124
- Pfizer Investigational Site
-
-
Sicily
-
Messina, Sicily, Italien, 98127
- Pfizer Investigational Site
-
-
Toscana
-
Pisa, Toscana, Italien, 56126
- Pfizer Investigational Site
-
-
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
Patients with early aggressive RA, who are treated in 15 specialized sites
Beskrivelse
Inclusion Criteria:
Inclusion Criteria Based On Clinical Practice of Aggressive RA
- Diagnosis of early aggressive RA in accordance with local guideline
- Disease duration < 2 years and at least six months since onset of symptoms
- Patients naïve to anti-TNFa drugs and DMARDs, including MTX, or assuming one or more DMARD without complete response
Exclusion Criteria:
Exclusion Criteria Based on Clinical Practice of Aggressive RA
- Patients should not be included in the study if they have participated in any interventional clinical trial within the previous 2 years.
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 |
|---|---|
|
1.0
As per routinary clinical practice
|
Dosage, form, frequency and duration as per ordinary clinical practice
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Prevalence of clinical remission, according to the DAS 28 definition of clinical remission, in patients with early aggressive RA receiving different therapies at 1 year.
Tidsramme: 12-24 months
|
12-24 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
-Prevalence of Remission at the second year.
Tidsramme: 12-24 months
|
12-24 months
|
|
Disease activity at the 1st and 2nd year
Tidsramme: 12-24 months
|
12-24 months
|
|
ACR 20%, 50%, 70% response at the 1st and 2nd year
Tidsramme: 12-24 months
|
12-24 months
|
|
QoL in patients with or without remission at the first and second year
Tidsramme: 12-24 months
|
12-24 months
|
|
Safety Evaluations
Tidsramme: 12-24 months
|
12-24 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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.
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. april 2006
Primær færdiggørelse (Faktiske)
1. juli 2010
Studieafslutning (Faktiske)
1. juli 2010
Datoer for studieregistrering
Først indsendt
19. december 2005
Først indsendt, der opfyldte QC-kriterier
19. december 2005
Først opslået (Skøn)
21. december 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. september 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. september 2011
Sidst verificeret
1. september 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0881A-101749
- B1801108
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 .