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

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: April 14, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted

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).

Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical and Therapeutic Management of the Rheumatoid Arthritis in Spain

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

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

Enrollment: 360
Study Start Date: December 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Patients with early RA


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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


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
  Contacts and Locations
Please refer to this study by its identifier: NCT00881881

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

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth Identifier: NCT00881881     History of Changes
Other Study ID Numbers: 0881A-102388
Study First Received: April 14, 2009
Last Updated: April 14, 2009
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on April 17, 2014