Ustekinumab Safety and Surveillance Program Using the Ing... | NCT01081730

Studies
Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database

NCT01081730

Sponsor

Janssen Biotech, Inc.

Status

Completed

Last Update Posted

Jun 25, 2025Actual

Enrollment

2,040Actual

Phase

Not provided

Conditions

Psoriasis

Interventions

anti-TNF biologics
general population
non-anti-TNF biologics
ustekinumab
systemic non-biological treatments

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CNTO1275PSO4006	Other Identifier	Janssen Research & Development, LLC

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 9, 2010Actual

Primary Completion Date

Sep 29, 2017Actual

Completion Date

Sep 29, 2017Actual

First Submitted Date

Mar 4, 2010

First Submission Date that Met QC Criteria

Mar 4, 2010

First Posted Date

Mar 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2025

Last Update Posted Date

Jun 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,040Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
001	ustekinumab as prescribed	Biological: ustekinumab
002	anti-TNF biologics as prescribed	Biological: anti-TNF biologics
003	non-anti-TNF biologics as prescribed	Biological: non-anti-TNF biologics
004	systemic non-biological treatments as prescribed	Drug: systemic non-biological treatments
005	general population non-treated cohort	Other: general population

Interventions

Name	Type	Description	Arm Group Labels	Other Names
anti-TNF biologics	Biological	as prescribed	002
general population

Outcomes Module

Primary Outcomes

Measure	Description	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		The study will be approximately 8 years in duration.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

99 Years

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janssen Biologics Europe Clinical Trial	Janssen Biotech, Inc.	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012961	Sociology
D000069549	Ustekinumab

Ancestor Terms

ID	Term
D012942	Social Sciences
D001525	Behavioral Sciences
D004191	Behavioral Disciplines and Activities
D061067	Antibodies, Monoclonal, Humanized

Browse Leaves

Not provided

Browse Branches

Not provided