Study Evaluating Impact of the Use of a Computer-based Tool on the Clinical Management of RA Patients

Rheumatoid Arthritis Clinical Trial

Official title:

Impact of the Use of a Computer-based Tools on the Clinical Management and Evolution of Patients With Rheumatoid Arthritis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895050
• Other study ID #: 0881X1-4576
• Secondary ID: B1801084
• Status: Completed
• Phase: N/A
• First received: May 6, 2009
• Last updated: July 13, 2011
• Start date: March 2009
• Est. completion date: January 2011

Study information

• Verified date: July 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial Summary

The primary purpose of this study is to evaluate a computer-based tool on the clinical management of patients with rheumatoid arthritis in Spain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Main Inclusion Criteria:

• Patients, male or female, over 18 years old.

• Patients diagnosed with RA according to investigator criteria

• Patients with a disease evolution >= 1 year

• Patients with > = 5 affected joints

Exclusion Criteria:

Exclusion Criteria:

• Patients with other muscle skeletal, rheumatic and/or degenerative diseases different from RA.

• Patients who are taking part or have taken part in a clinical trial or in a study with drugs within the last 12 months. Any condition that, in the investigator's judgment would interfere with the subject's ability to comply with protocol requirements or give informed consent.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Review of clinical records

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global mean DAS28 at 6 and at 12 months of follow-up. Differences between global mean DAS28 at 6 and at 12 months compared to baseline		12 months	No
Secondary	Disease activity (DAS28; number affected joints; CRP; ESR; PGA).-Number of variables used in patient's follow-up; number of treatment adjustments. -Investigator's satisfaction with the computer-based tool (specific questionnaire)		12 months	No

External Links

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