NCT Number: NCT00895050
Study Evaluating Impact of the Use of a Computer-based Tool on the Clinical Management of RA Patients
The primary purpose of this study is to evaluate a computer-based tool on the clinical management of patients with rheumatoid arthritis in Spain.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
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
Time frame: 12 months
Secondary outcomes
-
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)
Time frame: 12 months
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Lead sponsor
Pfizer
Industry
Registry information
Official study title
Impact of the Use of a Computer-based Tools on the Clinical Management and Evolution of Patients With Rheumatoid Arthritis.
Important dates
- Study start
- 2009
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- May 7, 2009
- Registry last updated
- Jul 15, 2011
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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