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

December 11, 2015 updated by: University of Arizona
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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

598

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona - Arizona Arthritis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with an inflammatory arthritis receiving care at our Rheumatology ambulatory clinic at the University of Arizona

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Biologics
Patients receiving TNF inhibitors or biologic agents
DMARD
Patients receiving methotrexate without any biologic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
To calculate the incidence density of coccidioidomycosis cases in patients receiving each drug.
Time Frame: One year
One year
To compare number of disseminated cases of coccidioidomycosis in each group
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

Centocor, Inc.

Investigators

  • Principal Investigator: Berchman A Vaz, MD, PhD, University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

November 21, 2008

First Submitted That Met QC Criteria

November 21, 2008

First Posted (Estimate)

November 24, 2008

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 11, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-0930-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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