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NCT00796809 Clinical Trial

Risk of Coccidioidomycosis in Patients Receiving Anti-TNF and Other Biologic Agents for an Inflammatory Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:
Risk of Coccidioidomycosis in Patients Receiving Anti-TNF and Other Biologic Agents for an Inflammatory Arthritis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00796809
Other study ID # 07-0930-04
Secondary ID
Status Completed
Phase N/A
First received November 21, 2008
Last updated December 11, 2015
Start date October 2007
Est. completion date October 2008

Study information
Verified date December 2015
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The goal of the project is to study the risk of coccidioidomycosis (valley fever) in patients receiving anti-TNF and other biologic agents for inflammatory arthritis in Tucson, Arizona.

Description:

Retrospective chart review of all patients with an inflammatory arthritis seen at the University Rheumatology clinic since January 2000.

Recruitment information / eligibility
Status Completed
Enrollment 598
Est. completion date October 2008
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All active patients with an inflammatory arthritis seen at the University of Arizona from January 2000

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Arizona - Arizona Arthritis Center Tucson Arizona

Sponsors (2)
Lead Sponsor Collaborator
University of Arizona Centocor, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determine the incidence rate and calculate the risk of coccidioidomycosis in patients receiving various anti-TNF agents or other biologics, and patients not receiving these agents for their inflammatory arthritis one year Yes
Secondary To calculate the incidence density of coccidioidomycosis cases in patients receiving each drug. One year Yes
Secondary To compare number of disseminated cases of coccidioidomycosis in each group One year Yes
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