CoccidioidomycosisNCT00796809
Risk of Coccidioidomycosis in Patients Receiving Anti-TNF and Other Biologic Agents for an Inflammatory Arthritis
An observational study of Coccidioidomycosis and Rheumatoid Arthritis, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coccidioidomycosis, Rheumatoid Arthritis
- How many people
- 598 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with an inflammatory arthritis receiving care at our Rheumatology ambulatory clinic at the University of Arizona
Who may be able to join
- All active patients with an inflammatory arthritis seen at the University of Arizona from January 2000
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona - Arizona Arthritis Center
Tucson, Arizona, 85724
About this study
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.
Read the detailed description
Retrospective chart review of all patients with an inflammatory arthritis seen at the University Rheumatology clinic since January 2000.
- Conditions
- Coccidioidomycosis, Rheumatoid Arthritis
- Keywords
- TNF inhibitors, Biologic agents, coccidioidomycosis, Rheumatoid arthritis
- Medical subject headings
- Coccidioidomycosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Biologics | Patients receiving TNF inhibitors or biologic agents | |
| DMARD | Patients receiving methotrexate without any biologic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (2)
To calculate the incidence density of coccidioidomycosis cases in patients receiving each drug.
Measured: One year
To compare number of disseminated cases of coccidioidomycosis in each group
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startOct 2007
- Primary completionJun 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoccidioidomycosisStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor, Inc.
- Responsible party
- Sponsor
- Investigators
- Berchman A Vaz, MD, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796809
- Sponsor's protocol ID
- 07-0930-04
- Status last verified
- Dec 2015
- First submitted
- 21 Nov 2008
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Coccidioidomycosis in Patients Receiving Anti-TNF and Other Biologic Agents for an Inflammatory Arthritis
- ClinicalTrials.gov ID
- NCT00796809
- Acronym / sponsor ID
- 07-0930-04
- Conditions
- Coccidioidomycosis, Rheumatoid Arthritis
- Keywords
- TNF inhibitors, Biologic agents, coccidioidomycosis, Rheumatoid arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Centocor, Inc.
- Study start
- Oct 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Retrospective chart review of all patients with an inflammatory arthritis seen at the University Rheumatology clinic since January 2000.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biologics | – | –Patients receiving TNF inhibitors or biologic agents |
| DMARD | – | –Patients receiving methotrexate without any biologic |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with an inflammatory arthritis receiving care at our Rheumatology ambulatory clinic at the University of Arizona
Key inclusion criteria (1 listed)
- All active patients with an inflammatory arthritis seen at the University of Arizona from January 2000
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
To calculate the incidence density of coccidioidomycosis cases in patients receiving each drug.
Time frame: One year
To compare number of disseminated cases of coccidioidomycosis in each group
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berchman A Vaz, MD, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coccidioidomycosis and Rheumatoid Arthritis, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.