- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01081730
Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database
February 19, 2019 updated by: Janssen Biotech, Inc.
A Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Psoriasis Treated With Ustekinumab and Other Types of Biological and Systemic Non-biological Treatments
The patients included in this observational study will be drawn from a research database containing claims and enrollment data for members of a large, geographically diverse US health plan.
The objective of this study is to estimate the rate of serious infections, tuberculosis, malignancies, and other outcomes in psoriasis patients treated with ustekinumab, anti-tumor necrosis factor (TNF) biologics, non-anti-TNF biologics, or systemic non-biological treatments.
Study Overview
Status
Completed
Conditions
Detailed Description
The participants included in this study will be drawn from the Ingenix Normative Health Informatics Database, a proprietary research database containing claims and enrollment data dating back to 1993 for members of a large, geographically diverse US health plan.
This study will include cohorts of participants who have claims consistent with a diagnosis of psoriasis and who initiate ustekinumab, anti-TNF biologics, non-anti-TNF biologics, or systemic non-biological treatments.
Participants will be identified by claims bearing codes for dispensed drugs, procedures or diagnoses and followed after the launch of ustekinumab for up to 8 years.
A sample of enrolled health plan members without claims evidence of diagnosis or treatment of psoriasis will also be selected.
The claims database will be used to estimate the incidence of the primary outcomes of serious infections, tuberculosis (TB) and non-TB mycobacterial infections, malignancies such as lymphoma, and other selected outcomes.
Potential cases of the study outcome identified through claims may be confirmed through medical record review.
No study agents will be administered in this study.
All patients will receive standard-of-care treatment as prescribed by their physician.
Study Type
Observational
Enrollment (Actual)
2040
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This study will include cohorts of participants who have claims consistent with a diagnosis of psoriasis and who initiate ustekinumab, anti-TNF biologics, non-anti-TNF biologics, or systemic non-biological treatments
Description
Inclusion Criteria:
- Complete medical coverage and pharmacy benefits
- Six months of continuous enrollment prior to the date of cohort entry
Exclusion Criteria:
- Participants will be excluded if they do not have information on age, gender or enrollment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
002
anti-TNF biologics as prescribed
|
as prescribed
|
003
non-anti-TNF biologics as prescribed
|
as prescribed
|
004
systemic non-biological treatments as prescribed
|
as prescribed
|
005
general population non-treated cohort
|
non-treated cohort
|
001
ustekinumab as prescribed
|
as prescribed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To estimate the incidence of serious infections, tuberculosis and non-TB mycobacterial infections, malignancies, and other selected outcomes in patients with psoriasis initiating ustekinumab and other biological and systemic non-biological treatments
Time Frame: The study will be approximately 8 years in duration.
|
The study will be approximately 8 years in duration.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Janssen Biologics Europe Clinical Trial, Janssen Biotech, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 9, 2010
Primary Completion (Actual)
September 29, 2017
Study Completion (Actual)
September 29, 2017
Study Registration Dates
First Submitted
March 4, 2010
First Submitted That Met QC Criteria
March 4, 2010
First Posted (Estimate)
March 5, 2010
Study Record Updates
Last Update Posted (Actual)
February 21, 2019
Last Update Submitted That Met QC Criteria
February 19, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR016723
- CNTO1275PSO4006 (Other Identifier: Janssen Biotech, Inc)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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