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.
Verified date | July 2011 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Comité Ético de Investigación Clínica |
Study type | Observational |
The primary purpose of this study is to evaluate a computer-based tool on the clinical management of patients with rheumatoid arthritis in Spain.
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
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 |
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