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

September 14, 2011 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25125
        • Pfizer Investigational Site
      • Genova, Italy
        • Pfizer Investigational Site
      • Messina, Italy, 98122
        • Pfizer Investigational Site
      • Padova, Italy, 35128
        • Pfizer Investigational Site
      • Palermo, Italy, 90100
        • Pfizer Investigational Site
      • Pavia, Italy, 27100
        • Pfizer Investigational Site
      • Siena, Italy, 53100
        • Pfizer Investigational Site
      • Torino, Italy, 10128
        • Pfizer Investigational Site
    • Ancona
      • Jesi, Ancona, Italy, 60035
        • Pfizer Investigational Site
    • Campania
      • Napoli, Campania, Italy, 80131
        • Pfizer Investigational Site
    • Ferrara (FE)
      • Ferrara, Ferrara (FE), Italy, 44100
        • Pfizer Investigational Site
    • GE
      • Arenzano, GE, Italy, 16011
        • Pfizer Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00161
        • Pfizer Investigational Site
    • Puglia
      • Bari, Puglia, Italy, 70124
        • Pfizer Investigational Site
    • Sicily
      • Messina, Sicily, Italy, 98127
        • Pfizer Investigational Site
    • Toscana
      • Pisa, Toscana, Italy, 56126
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with early aggressive RA, who are treated in 15 specialized sites

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1.0
As per routinary clinical practice
Other: as clinical practice
Dosage, form, frequency and duration as per ordinary clinical practice
Other Names:
  • observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 12-24 months
12-24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
-Prevalence of Remission at the second year.
Time Frame: 12-24 months
12-24 months
Disease activity at the 1st and 2nd year
Time Frame: 12-24 months
12-24 months
ACR 20%, 50%, 70% response at the 1st and 2nd year
Time Frame: 12-24 months
12-24 months
QoL in patients with or without remission at the first and second year
Time Frame: 12-24 months
12-24 months
Safety Evaluations
Time Frame: 12-24 months
12-24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

December 19, 2005

First Submitted That Met QC Criteria

December 19, 2005

First Posted (Estimate)

December 21, 2005

Study Record Updates

Last Update Posted (Estimate)

September 15, 2011

Last Update Submitted That Met QC Criteria

September 14, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0881A-101749
  • B1801108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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