Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database
NCT ID: NCT01081730
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2040 participants
OBSERVATIONAL
2010-02-09
2017-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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001
ustekinumab as prescribed
ustekinumab
as prescribed
002
anti-TNF biologics as prescribed
anti-TNF biologics
as prescribed
003
non-anti-TNF biologics as prescribed
non-anti-TNF biologics
as prescribed
004
systemic non-biological treatments as prescribed
systemic non-biological treatments
as prescribed
005
general population non-treated cohort
general population
non-treated cohort
Interventions
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anti-TNF biologics
as prescribed
general population
non-treated cohort
non-anti-TNF biologics
as prescribed
ustekinumab
as prescribed
systemic non-biological treatments
as prescribed
Eligibility Criteria
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Inclusion Criteria
* Six months of continuous enrollment prior to the date of cohort entry
Exclusion Criteria
0 Years
99 Years
ALL
No
Sponsors
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Janssen Biotech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Biologics Europe Clinical Trial
Role: STUDY_DIRECTOR
Janssen Biotech, Inc.
Other Identifiers
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CNTO1275PSO4006
Identifier Type: OTHER
Identifier Source: secondary_id
CR016723
Identifier Type: -
Identifier Source: org_study_id
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