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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00895050
First received: May 6, 2009
Last updated: July 13, 2011
Last verified: July 2011
  Purpose

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 Intervention
Rheumatoid Arthritis
Other: Review of clinical records

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 321
Study Start Date: March 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients diagnosed with RA
Other: Review of clinical records

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895050

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00895050     History of Changes
Other Study ID Numbers: 0881X1-4576, B1801084
Study First Received: May 6, 2009
Last Updated: July 13, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

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

ClinicalTrials.gov processed this record on July 22, 2014