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Study Evaluating the Clinical and Therapeutic Management of Rheumatoid Arthritis in Spain

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ClinicalTrials.gov Identifier: NCT00881881
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : April 15, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
This is an epidemiological, multicenter, retrospective study to analyze the management of rheumatoid arthritis (RA) in usual clinical practice in Spain. Two groups of patients will be analyzed: individuals who have had RA for two years or less (the "early RA" group) and individuals who have had RA for more than 2 years and who currently meet the ACR criteria for RA (the "established RA" group).

Condition or disease
Rheumatoid Arthritis

Study Type : Observational
Actual Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical and Therapeutic Management of the Rheumatoid Arthritis in Spain
Study Start Date : December 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine


Group/Cohort
1
Patients with early RA



Primary Outcome Measures :
  1. Therapeutic management of the RA (actual and 12 month follow-up) in a real-world setting. Descriptive analysis of sociodemographics and clinical variables for patients and sorted by group (early and established RA) for the last 12 months [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Measurements of diagnostic and outcomes used in the common clinical practice. Degree of follow-up of the actual Spanish consensus on clinical and therapeutic management of patients with RA [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with early RA and established RA treated in Rheumatology units in a real-world setting
Criteria

Inclusion criteria:

  • Group 1: early RA : patients with disease lasting 2 years or less, considered by the investigator as an early RA
  • Group 2: established RA: patients with disease lasting more than 2 years who meet the ACR criteria for RA

Exclusion criteria:

  • Patients with any rheumatic disease different from RA
  • Participation in any clinical trial or study in the last 12 months

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): NCT00881881


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00881881     History of Changes
Other Study ID Numbers: 0881A-102388
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: April 15, 2009
Last Verified: April 2009

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