Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database
Information source: Centocor Ortho Biotech Services, L.L.C.
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: anti-TNF biologics (Biological); systemic non-biological treatments (Drug); general population (Other); ustekinumab (Biological); non-anti-TNF biologics (Biological)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Centocor Ortho Biotech Services, L.L.C. Official(s) and/or principal investigator(s):
Centocor Ortho Biotech Services, L.L.C. Clinical Trial, Study Director, Affiliation: Centocor Ortho Biotech Services, L.L.C.
Overall contact:
This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: info1@veritasmedicine.com
Summary
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.
Clinical Details
Official title: 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
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: 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
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: info1@veritasmedicine.com Additional Information
Last updated: July 14, 2011
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