Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00881881
First received: April 14, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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
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)
Groups/Cohorts
1
Patients with early RA

  Eligibility

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

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
  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: 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
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov 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
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 24, 2014