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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:
ClinicalTrials.gov Identifier:
NCT00796809
First Posted: November 24, 2008
Last Update Posted: December 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
University of Arizona
  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:


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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00796809     History of Changes
Other Study ID Numbers: 07-0930-04
First Submitted: November 21, 2008
First Posted: November 24, 2008
Last Update Posted: December 14, 2015
Last Verified: December 2015

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