NCT00796809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
598

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

Enrollment Period

8 months

First QC Date

November 21, 2008

Last Update Submit

December 11, 2015

Conditions

CoccidioidomycosisRheumatoid Arthritis

Keywords

TNF inhibitorsBiologic agentscoccidioidomycosisRheumatoid arthritis

Outcome Measures

Primary Outcomes (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

    one year

Secondary Outcomes (2)

  • To calculate the incidence density of coccidioidomycosis cases in patients receiving each drug.

    One year

  • To compare number of disseminated cases of coccidioidomycosis in each group

    One year

Study Arms (2)

Biologics

Patients receiving TNF inhibitors or biologic agents

DMARD

Patients receiving methotrexate without any biologic

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with an inflammatory arthritis receiving care at our Rheumatology ambulatory clinic at the University of Arizona

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona - Arizona Arthritis Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

CoccidioidomycosisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Berchman A Vaz, MD, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2008

First Posted

November 24, 2008

Study Start

October 1, 2007

Primary Completion

June 1, 2008

Study Completion

October 1, 2008

Last Updated

December 14, 2015

Record last verified: 2015-12

Locations

US(1)