Study Evaluating the Clinical Remission in Early Aggressive Rheumatoid Arthritis (ARPA)

Wyeth

Status

Completed

Conditions

Rheumatoid Arthritis

Treatments

Other: as clinical practice

Study type

Observational

Funder types

Industry

Identifiers

NCT00267852

0881A-101749

B1801108

Details and patient eligibility

About

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

Full 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.

Enrollment

152 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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