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

This study has been completed.
Centocor, Inc.
Information provided by (Responsible Party):
University of Arizona Identifier:
First received: November 21, 2008
Last updated: December 11, 2015
Last verified: December 2015
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.

Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk of Coccidioidomycosis in Patients Receiving Anti-TNF and Other Biologic Agents for an Inflammatory Arthritis

Resource links provided by NLM:

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To calculate the incidence density of coccidioidomycosis cases in patients receiving each drug. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • To compare number of disseminated cases of coccidioidomycosis in each group [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Enrollment: 598
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Patients receiving TNF inhibitors or biologic agents
Patients receiving methotrexate without any biologic

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with an inflammatory arthritis receiving care at our Rheumatology ambulatory clinic at the University of Arizona

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00796809

United States, Arizona
University of Arizona - Arizona Arthritis Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Centocor, Inc.
Principal Investigator: Berchman A Vaz, MD, PhD University of Arizona
  More Information

Responsible Party: University of Arizona Identifier: NCT00796809     History of Changes
Other Study ID Numbers: 07-0930-04 
Study First Received: November 21, 2008
Last Updated: December 11, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
TNF inhibitors
Biologic agents
Rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Protozoan Infections
Parasitic Diseases processed this record on October 26, 2016