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

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ClinicalTrials.gov Identifier: NCT00796809
Recruitment Status : Completed
First Posted : November 24, 2008
Last Update Posted : December 14, 2015
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
University of Arizona

Brief 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.

Condition or disease
Coccidioidomycosis Rheumatoid Arthritis

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

Study Type : Observational
Actual Enrollment : 598 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk of Coccidioidomycosis in Patients Receiving Anti-TNF and Other Biologic Agents for an Inflammatory Arthritis
Study Start Date : October 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 :
  1. To calculate the incidence density of coccidioidomycosis cases in patients receiving each drug. [ Time Frame: One year ]
  2. To compare number of disseminated cases of coccidioidomycosis in each group [ Time Frame: One year ]


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Ages Eligible for Study:   Child, Adult, Older Adult
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:


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

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00796809     History of Changes
Other Study ID Numbers: 07-0930-04
First Posted: November 24, 2008    Key Record Dates
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