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Psoriasis Longitudinal Assessment and Registry (PSOLAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00508547
Recruitment Status : Active, not recruiting
First Posted : July 30, 2007
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Study Description
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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.

Condition or disease
Psoriasis

Detailed Description:
PSOLAR is an ongoing voluntary observational study in which infliximab-exposed patients, ustekinumab-exposed patients, and patients treated with other biologic and non-biologic standard of care therapies have been enrolled internationally and are followed for up to 8 years. Additionally, enrollment is opened to include at least 2000 guselkumab-exposed patients and up to 2000 patients exposed to IL-17 inhibitors. The Registry does not require any study-specific testing, but may capture information collected as part of normal routine care. Patient information is collected at the enrollment visit and about every 6 months thereafter. At enrollment, information on demographics (e.g. gender, and race), medical history and family medical history, details of past and current psoriasis treatments, and current psoriasis medications is collected. At enrollment and each follow-up visit, data are collected regarding physical examination, clinical disease status, Quality of Life assessments, current psoriasis medications, patient-reported PsA assessments, and adverse events. No study agents are administered for the purpose of this registry; all patients receive standard of care treatment as prescribed by the patient's physician.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 15834 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Years
Official Title: A Multicenter, Open Registry of Patients With Plaque Psoriasis Who Are Candidates for Systemic Therapy Including Biologics
Actual Study Start Date : June 21, 2007
Estimated Primary Completion Date : December 31, 2029
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events and Serious Adverse Events [ Time Frame: Up to 8 years of follow up for each patient ]
    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.


Secondary Outcome Measures :
  1. Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score [ Time Frame: At baseline and every 6 months through up to 8 years ]
  2. Evaluation of Disease Features: Body surface area [ Time Frame: At baseline and every 6 months through up to 8 years ]
  3. Evaluation of Disease Features: Psoriasis Area and Severity Index (PASI) Score [ Time Frame: At baseline and every 6 months through up to 8 years ]
  4. Dermatology Life Quality Index (DLQI) Score [ Time Frame: At baseline and every 6 months through up to 8 years ]
  5. EuroQOL quality of life assessment [ Time Frame: At baseline and every 6 months through up to 8 years ]
  6. Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: At baseline and every 6 months up to Month 18 and then every year up to 8 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient with psoriasis who meets the inclusion criteria will be eligible to participate in this registry.
Criteria

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508547


Locations
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Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
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Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00508547    
Other Study ID Numbers: CR013225
PSOLAR ( Other Identifier: Janssen Scientific Affairs, LLC )
First Posted: July 30, 2007    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Scientific Affairs, LLC:
psoriasis
psoriatic arthritis
skin disease
infliximab
ustekinumab
guselkumab
etanercept
 adalimumab
secukinumab
ixekizumab
brodalumab
systemic therapy
observational
registry
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases