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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.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00796809
First received: November 21, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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.


Condition
Coccidioidomycosis
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:

U.S. FDA Resources

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)
Groups/Cohorts
Biologics
Patients receiving TNF inhibitors or biologic agents
DMARD
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.

  Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796809

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

No publications provided

Responsible Party: Berchman AustinVaz, MD, University of Arizona
ClinicalTrials.gov Identifier: NCT00796809     History of Changes
Other Study ID Numbers: 07-0930-04
Study First Received: November 21, 2008
Last Updated: November 21, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Coccidioidomycosis
Coccidiosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycoses
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on May 19, 2013