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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 August 2023 |
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Main ID: |
NCT02922192 |
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Date of registration:
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28/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis
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Scientific title:
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Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis |
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Date of first enrolment:
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January 1, 2012 |
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Target sample size:
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90360 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02922192 |
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Study type:
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Observational |
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Study design:
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Phase:
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Contacts
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Name:
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Kevin Haynes, PharmD, MSCE |
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Address:
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Telephone:
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Email:
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Affiliation:
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Anthem HealthCore, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Individuals with baseline period of 365 days with continuous medical and pharmacy
coverage preceding the first prescription fill
- new and users of the following exposures
- TNF -a antagonists (including adalimumab, certolizumab, etanercept [not included
for IBD], golimumab, infliximab, and natalizumab [IBD only])
- Non-TNF-alpha antagonist biologics in RA only (abatacept, rituximab, and
tocilizumab)
- Non-biologic medications (after any use of methotrexate in the previous year
includes RA: hydroxychloroquine, leflunomide, or sulfasalazine; IBD: 6-
mercaptopurine or azathioprine; PsO-PsA-AS: methotrexate, leflunomide, or
sulfasalazine).
Exclusion Criteria:
- During baseline 365 days, any patient with
- Active cancer or a history of non-melanoma cancer*
- Any immunocompromising conditions (organ transplantation, HIV, and advanced
kidney/liver disease)*
- *if occur during the follow-up period, patients also will be censored.
- During baseline 183 days, any patient with hospitalization for any infection
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Psoriasis
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Inflammatory Bowel Disease
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Psoriatic Arthritis
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Ankylosing Spondylitis
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Rheumatoid Arthritis
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Intervention(s)
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Drug: TNF-a antagonists, non-TNFs, DMARD non-biologics
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Primary Outcome(s)
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Incidence of hospitalization for serious infections
[Time Frame: Anticipated completion January 2017]
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Secondary ID(s)
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BBCIC-Anti-inflammatory
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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