Study Evaluating the Clinical and Therapeutic Management of Rheumatoid Arthritis in Spain

April 14, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

Clinical and Therapeutic Management of the Rheumatoid Arthritis in Spain

This is an epidemiological, multicenter, retrospective study to analyze the management of rheumatoid arthritis (RA) in usual clinical practice in Spain. Two groups of patients will be analyzed: individuals who have had RA for two years or less (the "early RA" group) and individuals who have had RA for more than 2 years and who currently meet the ACR criteria for RA (the "established RA" group).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

360

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

Probability Sample

Study Population

Patients with early RA and established RA treated in Rheumatology units in a real-world setting

Description

Inclusion criteria:

  • Group 1: early RA : patients with disease lasting 2 years or less, considered by the investigator as an early RA
  • Group 2: established RA: patients with disease lasting more than 2 years who meet the ACR criteria for RA

Exclusion criteria:

  • Patients with any rheumatic disease different from RA
  • Participation in any clinical trial or study in the last 12 months

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: Retrospective

Cohorts and Interventions

Group / Cohort
1
Patients with early RA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Therapeutic management of the RA (actual and 12 month follow-up) in a real-world setting. Descriptive analysis of sociodemographics and clinical variables for patients and sorted by group (early and established RA) for the last 12 months
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurements of diagnostic and outcomes used in the common clinical practice. Degree of follow-up of the actual Spanish consensus on clinical and therapeutic management of patients with RA
Time Frame: 12 months
12 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

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

December 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

April 14, 2009

First Submitted That Met QC Criteria

April 14, 2009

First Posted (Estimate)

April 15, 2009

Study Record Updates

Last Update Posted (Estimate)

April 15, 2009

Last Update Submitted That Met QC Criteria

April 14, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0881A-102388

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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