NCT00267852

Study Evaluating the Clinical Remission in Early Aggressive Rheumatoid Arthritis

An Observational Study To Evaluate The Clinical Remission In Early Aggressive Rheumatoid Arthritis (Artrite Reumatoide Precoce Aggressiva Italian Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 152 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
OTHER	as clinical practice	Dosage, form, frequency and duration as per ordinary clinical practice

Timeline

• Start date: 2006-04-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2005-12-21
• Last updated: 2011-09-15

Locations

16 sites across 1 country: Italy