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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00508547
Registration number
NCT00508547
Ethics application status
Date submitted
27/07/2007
Date registered
30/07/2007
Date last updated
14/08/2024
Titles & IDs
Public title
Psoriasis Longitudinal Assessment and Registry
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Scientific title
A Multicenter, Open Registry of Patients With Plaque Psoriasis Who Are Candidates for Systemic Therapy Including Biologics
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Secondary ID [1]
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PSOLAR
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Secondary ID [2]
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CR013225
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Universal Trial Number (UTN)
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Trial acronym
PSOLAR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriasis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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0
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Other skin conditions
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Adverse Events and Serious Adverse Events
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Assessment method [1]
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An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; suspected transmission of any infectious agent via medicinal product; any important medical events. All adverse events, including those of special interest, such as malignancies;TB;opportunistic infections;depression;hypersensitivity reactions; autoimmune disease; neurologic or demyelinating events; congestive heart failure; gastrointestinal events; demyelinating disease, hepatotoxicity; hematologic events; unexpected reaction to a vaccine;cerebrovascular accident; transient ischemic attack; confirmed myocardial infarction; acquired immunodeficiency syndrome will be documented.
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Timepoint [1]
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Up to 8 years of follow up for each patient
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Secondary outcome [1]
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Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score
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Assessment method [1]
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Timepoint [1]
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At baseline and every 6 months through up to 8 years
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Secondary outcome [2]
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Evaluation of Disease Features: Body surface area
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Assessment method [2]
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Timepoint [2]
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At baseline and every 6 months through up to 8 years
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Secondary outcome [3]
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Evaluation of Disease Features: Psoriasis Area and Severity Index (PASI) Score
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Assessment method [3]
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Timepoint [3]
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At baseline and every 6 months through up to 8 years
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Secondary outcome [4]
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Dermatology Life Quality Index (DLQI) Score
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Assessment method [4]
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Timepoint [4]
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At baseline and every 6 months through up to 8 years
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Secondary outcome [5]
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EuroQOL quality of life assessment
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Assessment method [5]
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Timepoint [5]
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At baseline and every 6 months through up to 8 years
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Secondary outcome [6]
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Hospital Anxiety and Depression Scale (HADS) Score
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Assessment method [6]
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Timepoint [6]
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At baseline and every 6 months up to Month 18 and then every year up to 8 years
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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
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Minimum age
18
Years
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Maximum age
99
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/06/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2030
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Actual
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Sample size
Target
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Accrual to date
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Final
15842
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Recruitment in Australia
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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
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Porto
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Portugal
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Vila Nova de Gaia
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Slovakia
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Banska Bystrica
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Bratislava
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Kosice
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Slovakia
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Martin
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Nitra
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Slovakia
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Poprad
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Slovakia
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Presov
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Slovakia
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Trnava
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Slovenia
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Celje
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Slovenia
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Izola
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Slovenia
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Kranj
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Slovenia
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Ljubljana
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Slovenia
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Maribor
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Bilbao
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Spain
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Granada
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
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Murcia
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Spain
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Salamanca
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Spain
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Santiago de Compostela
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Sweden
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Eskilstuna
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Sweden
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Goteborg
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Sweden
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Kungsbacka
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Sweden
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Stockholm
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei-City
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Taiwan
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Taipei
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Taiwan
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Taoyuan County
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Ukraine
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Dnepropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Kharkiv
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Ukraine
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Khmelnitskiy
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Ukraine
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Kiev
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Ukraine
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Lugansk
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Ukraine
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Simferopol
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Ukraine
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Uzhgorod
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Scientific Affairs, LLC
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00508547
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Trial related presentations / publications
Ritchlin CT, Stahle M, Poulin Y, Bagel J, Chakravarty SD, Kafka S, Srivastava B, Langholff W, Gottlieb AB. Serious infections in patients with self-reported psoriatic arthritis from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) treated with biologics. BMC Rheumatol. 2019 Nov 28;3:52. doi: 10.1186/s41927-019-0094-3. eCollection 2019. Kavanaugh A, Papp K, Gottlieb AB, de Jong EMGJ, Chakravarty SD, Kafka S, Langholff W, Farahi K, Srivastava B, Scher JU. Demography, baseline disease characteristics, and treatment history of psoriasis patients with self-reported psoriatic arthritis enrolled in the PSOLAR registry. BMC Rheumatol. 2018 Sep 29;2:29. doi: 10.1186/s41927-018-0034-7. eCollection 2018. Singh S, Kalb RE, de Jong EMGJ, Shear NH, Lebwohl M, Langholff W, Hopkins L, Srivastava B, Armstrong AW. Effect of Age of Onset of Psoriasis on Clinical Outcomes with Systemic Treatment in the Psoriasis Longitudinal Assessment and Registry (PSOLAR). Am J Clin Dermatol. 2018 Dec;19(6):879-886. doi: 10.1007/s40257-018-0388-z. Strober BE, Bissonnette R, Fiorentino D, Kimball AB, Naldi L, Shear NH, Goyal K, Fakharzadeh S, Calabro S, Langholff W, You Y, Galindo C, Lee S, Lebwohl MG. Comparative effectiveness of biologic agents for the treatment of psoriasis in a real-world setting: Results from a large, prospective, observational study (Psoriasis Longitudinal Assessment and Registry [PSOLAR]). J Am Acad Dermatol. 2016 May;74(5):851-61.e4. doi: 10.1016/j.jaad.2015.12.017. Epub 2016 Feb 4. Kalb RE, Fiorentino DF, Lebwohl MG, Toole J, Poulin Y, Cohen AD, Goyal K, Fakharzadeh S, Calabro S, Chevrier M, Langholff W, You Y, Leonardi CL. Risk of Serious Infection With Biologic and Systemic Treatment of Psoriasis: Results From the Psoriasis Longitudinal Assessment and Registry (PSOLAR). JAMA Dermatol. 2015 Sep;151(9):961-9. doi: 10.1001/jamadermatol.2015.0718.
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Public notes
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Contacts
Principal investigator
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Janssen Scientific Affairs, LLC Clinical Trial
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Janssen Scientific Affairs, LLC
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
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Results publications and other study-related documents
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Results not provided in
https://clinicaltrials.gov/study/NCT00508547
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