Current Adoption of Composite Indices in Evaluating Rheumatoid Arthritis Patients: An Observational Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

293 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-06-30

Brief Summary

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This is an observational study of composite indices, including the CLARA (CLinical ARthritis Activity) index, in rheumatoid arthritis (RA) patients in routine clinical practice in Italy in order to evaluate clinical remission and low disease activity. Data will be collected only from patients providing informed consent. In this study we aimed to assess the psychometric properties of a new composite instrument termed CLinical ARthritis Activity (PRO-CLARA) that uses only three PRO measures from among the 7 ACR Core Data Set. We hypothesized that this index would facilitate rapid and easy RA activity assessment in daily routine.

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Detailed Description

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All patients who respond to inclusion/exclusion criteria at baseline will be considered valuable for the analysis.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

As per routine clinical care

As per routinary clinical care

Intervention Type OTHER

As per routine clinical care

Interventions

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As per routinary clinical care

As per routine clinical care

Intervention Type OTHER

Other Intervention Names

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Observational study

Eligibility Criteria

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Inclusion Criteria

* Eighteen years of age or older with diagnosis of RA based on the 1987 American College of Rheumatology (ACR) criteria and in accordance with local guidelines.
* Patients eligible to anti-TNF therapy
* Patients naïve to anti-TNFa drugs
* Patients with radiography (hands and feet) executed by 6 months before the baseline or at baseline according to modified Sharp Van der Hejde method \[Sharp JT et al. 1985; Sharp JT. Et al. 1989; Van der Heijde DM et al. 1989\] Patients capable of understanding and completing the questionnaire Patients capable of understanding and signing an informed consent form