Study Evaluating the Clinical Remission in Early Aggressive Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— ARPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00267852
• Other study ID #: 0881A-101749
• Secondary ID: B1801108
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2005
• Last updated: September 14, 2011
• Start date: April 2006
• Est. completion date: July 2010

Study information

• Verified date: September 2011
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• as clinical practice
Dosage, form, frequency and duration as per ordinary clinical practice

Locations

Country	Name	City	State
Italy	Pfizer Investigational Site	Arenzano	GE
Italy	Pfizer Investigational Site	Bari	Puglia
Italy	Pfizer Investigational Site	Brescia
Italy	Pfizer Investigational Site	Ferrara	Ferrara (FE)
Italy	Pfizer Investigational Site	Genova
Italy	Pfizer Investigational Site	Jesi	Ancona
Italy	Pfizer Investigational Site	Messina	Sicily
Italy	Pfizer Investigational Site	Messina
Italy	Pfizer Investigational Site	Napoli	Campania
Italy	Pfizer Investigational Site	Padova
Italy	Pfizer Investigational Site	Palermo
Italy	Pfizer Investigational Site	Pavia
Italy	Pfizer Investigational Site	Pisa	Toscana
Italy	Pfizer Investigational Site	Roma	Lazio
Italy	Pfizer Investigational Site	Siena
Italy	Pfizer Investigational Site	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12-24 months	No
Secondary	-Prevalence of Remission at the second year.		12-24 months	No
Secondary	Disease activity at the 1st and 2nd year		12-24 months	No
Secondary	ACR 20%, 50%, 70% response at the 1st and 2nd year		12-24 months	No
Secondary	QoL in patients with or without remission at the first and second year		12-24 months	No
Secondary	Safety Evaluations		12-24 months	No

External Links

•   To obtain contact information for a study center near you, click here.