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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00895050
Recruitment Status : Completed
First Posted : May 7, 2009
Last Update Posted : July 15, 2011
Sponsor:
Information provided by:
Pfizer

Brief 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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Other: Review of clinical records

Study Type : Observational
Actual Enrollment : 321 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of the Use of a Computer-based Tools on the Clinical Management and Evolution of Patients With Rheumatoid Arthritis.
Study Start Date : March 2009
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
1
Patients diagnosed with RA
Other: Review of clinical records



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with RA treated in rheumatology offices
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895050


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00895050     History of Changes
Other Study ID Numbers: 0881X1-4576
B1801084
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: July 15, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases