Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT01081730
First received: March 4, 2010
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Psoriasis
Biological: anti-TNF biologics
Other: general population
Biological: non-anti-TNF biologics
Biological: ustekinumab
Drug: systemic non-biological treatments
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Janssen Biotech, Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: February 2010
Estimated Study Completion Date: April 2018
Groups/Cohorts Assigned Interventions
001
ustekinumab as prescribed
Biological: ustekinumab
as prescribed
002
anti-TNF biologics as prescribed
Biological: anti-TNF biologics
as prescribed
003
non-anti-TNF biologics as prescribed
Biological: non-anti-TNF biologics
as prescribed
004
systemic non-biological treatments as prescribed
Drug: systemic non-biological treatments
as prescribed
005
general population non-treated cohort
Other: general population
non-treated cohort

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081730

Locations
United States, Massachusetts
Ingenix - i3 Drug Safety
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Janssen Biotech, Inc.
Investigators
Study Director: Janssen Biologics Europe Clinical Trial Janssen Biotech, Inc.
  More Information

No publications provided

Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT01081730     History of Changes
Other Study ID Numbers: CR016723, CNTO1275PSO4006
Study First Received: March 4, 2010
Last Updated: August 15, 2014
Health Authority: United States: New England Institutional Review Board

Keywords provided by Janssen Biotech, Inc.:
psoriasis
ustekinumab
anti-TNF biologics
non-anti-TNF biologics
systemic non-biological treatments

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014