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

Sponsors and Collaborators:	University of Arizona 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

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Keywords provided by University of Arizona:

TNF inhibitors
Biologic agents
coccidioidomycosis
Rheumatoid arthritis

Study placed in the following topic categories:

Mycoses
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Coccidioidomycosis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009