Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Centocor, Inc.
Information provided by:
University of Arizona Identifier:
First received: November 21, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted

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.

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 ] [ 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)
Patients receiving TNF inhibitors or biologic agents
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.


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


Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00796809

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

No publications provided

Responsible Party: Berchman AustinVaz, MD, University of Arizona 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
Rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Parasitic Diseases
Protozoan Infections
Rheumatic Diseases processed this record on March 03, 2015