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

Pfizer

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: As per routinary clinical care

Study type: Observational

Funder types: Industry

Identifiers

NCT00793403

0881A-102317 B1801118;

0881A1-102317

Details and patient eligibility

About

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.

Full description

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

Enrollment: 293 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Patients with tumors
• Patients already included in clinical trials

Trial design

293 participants in 1 patient group

1

Description:

As per routine clinical care

Treatment:

Other: As per routinary clinical care