Clinical trial NCT00267852: Study Evaluating the Clinical Remission in Early Aggressive Rheumatoid Arthritis
Official title: An Observational Study To Evaluate The Clinical Remission In Early Aggressive Rheumatoid Arthritis (Artrite Reumatoide Precoce Aggressiva Italian Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-12-21
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with early aggressive RA, who are treated in 15 specialized sites

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 12-24 months
Secondary outcomes:
measure: -Prevalence of Remission at the second year.
timeFrame: 12-24 months
measure: Disease activity at the 1st and 2nd year
timeFrame: 12-24 months
measure: ACR 20%, 50%, 70% response at the 1st and 2nd year
timeFrame: 12-24 months
measure: QoL in patients with or without remission at the first and second year
timeFrame: 12-24 months
measure: Safety Evaluations
timeFrame: 12-24 months
Other outcomes:
Locations:
city: Jesi
country: Italy
facility: Pfizer Investigational Site
state: Ancona
city: Napoli
country: Italy
facility: Pfizer Investigational Site
state: Campania
city: Ferrara
country: Italy
facility: Pfizer Investigational Site
state: Ferrara (FE)
city: Arenzano
country: Italy
facility: Pfizer Investigational Site
state: GE
city: Roma
country: Italy
facility: Pfizer Investigational Site
state: Lazio
city: Bari
country: Italy
facility: Pfizer Investigational Site
state: Puglia
city: Messina
country: Italy
facility: Pfizer Investigational Site
state: Sicily
city: Pisa
country: Italy
facility: Pfizer Investigational Site
state: Toscana
city: Brescia
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Messina
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Palermo
country: Italy
facility: Pfizer Investigational Site
city: Pavia
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: