NCT00895050

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

July 15, 2011

Status Verified

July 1, 2011

Enrollment Period

1.8 years

First QC Date

May 6, 2009

Last Update Submit

July 13, 2011

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (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

    12 months

Secondary Outcomes (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)

    12 months

Study Arms (1)

1

Patients diagnosed with RA

Other: Review of clinical records

Interventions

Review of clinical recordsOTHER
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with RA treated in rheumatology offices

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 6, 2009

First Posted

May 7, 2009

Study Start

March 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

July 15, 2011

Record last verified: 2011-07