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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00508547




Registration number
NCT00508547
Ethics application status
Date submitted
27/07/2007
Date registered
30/07/2007
Date last updated
22/05/2024

Titles & IDs
Public title
Psoriasis Longitudinal Assessment and Registry
Scientific title
A Multicenter, Open Registry of Patients With Plaque Psoriasis Who Are Candidates for Systemic Therapy Including Biologics
Secondary ID [1] 0 0
PSOLAR
Secondary ID [2] 0 0
CR013225
Universal Trial Number (UTN)
Trial acronym
PSOLAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Guselkumab - Participants will receive guselkumab as prescribed by a physician according to standard of care for psoriasis.

Infliximab - Participants will receive infliximab as prescribed by a physician according to standard of care for psoriasis.

Ustekinumab - Participants will receive ustekinumab as prescribed by a physician according to standard of care for psoriasis.

Biological Therapies - Participants will receive biological therapies other than infliximab, ustekinumab, guselkumab, and IL-17 inhibitors as prescribed by a physician for psoriasis. Participants will not receive any intervention as a part of this study.

Conventional Systemic Agents - Participants will receive conventional systemic agents as prescribed by a physician for psoriasis. Participants will not receive any intervention as a part of this study.

IL-17 Inhibitor - Participants will receive an IL-17 inhibitor as prescribed by a physician according to standard of care for psoriasis.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events and Serious Adverse Events
Timepoint [1] 0 0
Up to 8 years of follow up for each patient
Secondary outcome [1] 0 0
Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score
Timepoint [1] 0 0
At baseline and every 6 months through up to 8 years
Secondary outcome [2] 0 0
Evaluation of Disease Features: Body surface area
Timepoint [2] 0 0
At baseline and every 6 months through up to 8 years
Secondary outcome [3] 0 0
Evaluation of Disease Features: Psoriasis Area and Severity Index (PASI) Score
Timepoint [3] 0 0
At baseline and every 6 months through up to 8 years
Secondary outcome [4] 0 0
Dermatology Life Quality Index (DLQI) Score
Timepoint [4] 0 0
At baseline and every 6 months through up to 8 years
Secondary outcome [5] 0 0
EuroQOL quality of life assessment
Timepoint [5] 0 0
At baseline and every 6 months through up to 8 years
Secondary outcome [6] 0 0
Hospital Anxiety and Depression Scale (HADS) Score
Timepoint [6] 0 0
At baseline and every 6 months up to Month 18 and then every year up to 8 years

Eligibility
Key inclusion criteria
- Have a diagnosis of psoriasis

- Incident or prevalent users of Tremfya or an IL-17 inhibitor (eg, secukinumab,
ixekizumab, brodalumab, bimekizumab) at the time of their enrollment. Incident users
are defined as those participants starting treatment within 30 days before or after
the enrollment visit and prevalent users are defined as those who are on treatment
greater than 30 days prior to the enrollment visit

- Ability to understand and sign an informed consent form

- Are willing to participate in regular follow-up visits
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Refuse to consent or are unwilling to respond to requests for long term information
within the required time frame

- Are participating or have already planned to participate in a clinical trial with
non-marketed investigational agents or are participating in a Janssen-sponsored
clinical trial with marketed agents

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
Accrual to date
Final
15835
Recruitment in Australia
Recruitment state(s)
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- Fremantle
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- Melbourne
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- Miranda
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- Sydney
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- Woolloongabba
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- Fremantle
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- Melbourne
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- Miranda
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- Sydney
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- Woolloongabba
Recruitment outside Australia
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Alcalá de Henares
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Bilbao
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Granada
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Madrid
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Murcia
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Salamanca
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Santiago de Compostela
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Sweden
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Eskilstuna
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Goteborg
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Kungsbacka
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Stockholm
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Taiwan
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Kaohsiung
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Taichung
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Taipei
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Taoyuan County
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Kharkiv
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Kiev
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Uzhgorod

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Scientific Affairs, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to further evaluate the safety of infliximab, ustekinumab, and
guselkumab in patients with plaque and other forms of psoriasis. The study also includes
patients receiving other therapies, such as non-biologic and other biologic agents. The
registry also evaluates patient and disease characteristics, including patient-reported
assessment of psoriatic arthritis (PsA); and clinical and quality of life outcomes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00508547
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Scientific Affairs, LLC Clinical Trial
Address 0 0
Janssen Scientific Affairs, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00508547