PsoriasisNCT01081730
Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database
An observational study of Psoriasis, run by Janssen Biotech, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 99 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- anti-TNF biologics, general population and non-anti-TNF biologics
- How many people
- 2,040 participants
- Where
- No sites listed yet
- Study dates
- 9 Feb 2010to 29 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older 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
Who may be able to join
- Complete medical coverage and pharmacy benefits
- Six months of continuous enrollment prior to the date of cohort entry
Who cannot join
- Participants will be excluded if they do not have information on age, gender or enrollment
About this study
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
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- anti-TNF biologics, general population, non-anti-TNF biologics, ustekinumab, systemic non-biological treatments
- Keywords
- psoriasis, ustekinumab, anti-TNF biologics, non-anti-TNF biologics, systemic non-biological treatments
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-TNF biologicsBiological
as prescribed
general populationOther
non-treated cohort
non-anti-TNF biologicsBiological
as prescribed
ustekinumabBiological
as prescribed
systemic non-biological treatmentsDrug
as prescribed
| Study group | Role | What they receive |
|---|---|---|
| 001 | ustekinumab as prescribed Receives: Biological: ustekinumab | |
| 002 | anti-TNF biologics as prescribed Receives: Biological: anti-TNF biologics | |
| 003 | non-anti-TNF biologics as prescribed Receives: Biological: non-anti-TNF biologics | |
| 004 | systemic non-biological treatments as prescribed Receives: Drug: systemic non-biological treatments | |
| 005 | general population non-treated cohort Receives: Other: general population |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The study will be approximately 8 years in duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study start9 Feb 2010
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Biologics Europe Clinical Trial, Study director, Janssen Biotech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081730
- Sponsor's protocol ID
- CR016723
- Other IDs
- CNTO1275PSO4006
- Status last verified
- Jun 2025
- First submitted
- 4 Mar 2010
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01081730
- Acronym / sponsor ID
- CR016723
- Conditions
- Psoriasis
- Keywords
- psoriasis, ustekinumab, anti-TNF biologics, non-anti-TNF biologics, systemic non-biological treatments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,040 participants (actual)
- Lead sponsor
- Janssen Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2010 (actual)
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 5 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Biological: ustekinumabustekinumab as prescribed |
| 002 | – | Biological: anti-TNF biologicsanti-TNF biologics as prescribed |
| 003 | – | Biological: non-anti-TNF biologicsnon-anti-TNF biologics as prescribed |
| 004 | – | Drug: systemic non-biological treatmentssystemic non-biological treatments as prescribed |
| 005 | – | Other: general populationgeneral population non-treated cohort |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (2 listed)
- Complete medical coverage and pharmacy benefits
- Six months of continuous enrollment prior to the date of cohort entry
Key exclusion criteria (1 listed)
- Participants will be excluded if they do not have information on age, gender or enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-TNF biologicsas prescribed | Biological | 002 |
| general populationnon-treated cohort | Other | 005 |
| non-anti-TNF biologicsas prescribed | Biological | 003 |
| ustekinumabas prescribed | Biological | 001 |
| systemic non-biological treatmentsas prescribed | Drug | 004 |
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
Time frame: The study will be approximately 8 years in duration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Biologics Europe Clinical Trial study director
Janssen Biotech, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Janssen Biotech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: The study will be approximately 8 years in duration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.