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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


Phase 4
N/A
N/A
Open (Enrolling)
Both
Psoriasis

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Trial Information

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 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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

The study will be approximately 8 years in duration.

Safety Issue:

Yes

Principal Investigator

Janssen Biologics Europe Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Biotech, Inc.

Authority:

United States: New England Institutional Review Board

Study ID:

CR016723

NCT ID:

NCT01081730

Start Date:

February 2010

Completion Date:

April 2018

Related Keywords:

  • Psoriasis
  • psoriasis
  • ustekinumab
  • anti-TNF biologics
  • non-anti-TNF biologics
  • systemic non-biological treatments
  • Psoriasis

Name

Location

Ingenix - i3 Drug SafetyWaltham, Massachusetts  02451