Risk of Coccidioidomycosis in Patients Receiving Anti-TNF and Other Biologic Agents for an Inflammatory Arthritis
This study has been completed.
Sponsor:
University of Arizona
Collaborator:
Centocor, Inc.
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00796809
First received: November 21, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | November 21, 2008 | ||||
| Last Updated Date | November 21, 2008 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Risk of Coccidioidomycosis in Patients Receiving Anti-TNF and Other Biologic Agents for an Inflammatory Arthritis | ||||
| Official Title ICMJE | Risk of Coccidioidomycosis in Patients Receiving Anti-TNF and Other Biologic Agents for an Inflammatory Arthritis | ||||
| 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. |
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| Detailed Description | Retrospective chart review of all patients with an inflammatory arthritis seen at the University Rheumatology clinic since January 2000. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients with an inflammatory arthritis receiving care at our Rheumatology ambulatory clinic at the University of Arizona |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 598 | ||||
| Completion Date | October 2008 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00796809 | ||||
| Other Study ID Numbers ICMJE | 07-0930-04 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Berchman AustinVaz, MD, University of Arizona | ||||
| Study Sponsor ICMJE | University of Arizona | ||||
| Collaborators ICMJE | Centocor, Inc. | ||||
| Investigators ICMJE |
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| Information Provided By | University of Arizona | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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