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

Sponsor:	University of Arizona
Collaborator:	Centocor, Inc.
Information provided by:	University of Arizona
ClinicalTrials.gov Identifier:	NCT00796809

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:

MedlinePlus related topics: Rheumatoid Arthritis Valley Fever

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 February 09, 2012