Study Evaluating the Clinical Remission in Early Aggressive Rheumatoid Arthritis

NCT ID: NCT00267852

Last Updated: 2011-09-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 152 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2010-07-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1.0

As per routinary clinical practice

as clinical practice

Intervention Type: OTHER

Dosage, form, frequency and duration as per ordinary clinical practice

Interventions

as clinical practice

Dosage, form, frequency and duration as per ordinary clinical practice

Intervention Type: OTHER

Other Intervention Names

observational study

Eligibility Criteria

Inclusion Criteria

• 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

• Patients should not be included in the study if they have participated in any interventional clinical trial within the previous 2 years.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

Iesi, Ancona, Italy

Pfizer Investigational Site

Bari, Apulia, Italy

Pfizer Investigational Site

Napoli, Campania, Italy

Pfizer Investigational Site

Ferrara, Ferrara (FE), Italy

Pfizer Investigational Site

Arenzano, GE, Italy

Pfizer Investigational Site

Rome, Lazio, Italy

Pfizer Investigational Site

Messina, Messina, Italy

Pfizer Investigational Site

Padua, Padova, Italy

Pfizer Investigational Site

Palermo, Palermo, Italy

Pfizer Investigational Site

Messina, Sicily, Italy

Pfizer Investigational Site

Siena, Siena, Italy

Pfizer Investigational Site

Pisa, Tuscany, Italy

Pfizer Investigational Site

Brescia, , Italy

Pfizer Investigational Site

Genova, , Italy

Pfizer Investigational Site

Pavia, , Italy

Pfizer Investigational Site

Torino, , Italy

Countries

Italy

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881A-101749&StudyName=Study%20Evaluating%20the%20Clinical%20Remission%20in%20Early%20Aggressive%20Rheumatoid%20Arthritis

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

Other Identifiers

B1801108

Identifier Type: -

Identifier Source: secondary_id

0881A-101749

Identifier Type: -

Identifier Source: org_study_id