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Trial record 4 of 4 for:    Menkes Disease

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00508547
Recruitment Status : Recruiting
First Posted : July 30, 2007
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Brief Summary:
The purpose of this study is to further evaluate the safety of infliximab, ustekinumab, and guselkumab in patients with plaque psoriasis, and other all forms of psoriasis (such as plaque psoriasis and psoriatic arthritis occurring together). The registry study will track the behavior of the disease in response to other therapies, such as other biologic drugs. The registry will also evaluate clinical outcomes; disease characteristics, including physician reported assessment of psoriatic arthritis (PsA); quality of life, and potential risks for patients who may receive standard therapies for psoriasis.

Condition or disease Intervention/treatment
Psoriasis Arthritis, Psoriatic Biological: Ustekinumab Biological: Biological therapies other than infliximab, ustekinumab and guselkumab Drug: Conventional systemic agents Biological: Infliximab Biological: Guselkumab

Detailed Description:
PSOLAR is an 8 year registry study. A registry is an observational study that evaluates the status of a disease. This registry study will only include patients who volunteer to take part. About 4000 infliximab-exposed patients, 4000 ustekinumab-exposed patients and as well as a comparable number of patients (4000) on other standard of care psoriasis therapies (e.g. Etanercept) and/or psoriasis treatments (e.g. topical or light therapy treatments) will take part in the registry study, internationally. Additionally, enrollment will be opened to include at least 2,000 guselkumab-exposed patients and up to 2,000 patients exposed to IL-17 inhibitors (example, secukinumab, ixekizumab, brodalumab). The Registry does not require any study-specific testing, but may capture test information (e.g. laboratory tests, X-rays) that are collected as part of normal routine care for the registry program. Patient information will be collected at the enrollment visit and about every 6 months thereafter. At enrollment, information on demographics (e.g. gender, race, date of birth), medical history and family medical history, details of past and current psoriasis treatments (e.g. infliximab and standard therapy), and current medication regimens will be collected. Clinical follow-up will be based on observations from physical examination, clinical disease status, Quality of Life assessment (e.g. Dermatology Life Quality Index, Hospital Anxiety and Depression Scale, EQ-5D (EuroQoL-5D is a Quality of Life Questionnaire) Health Questionnaire Scale, Employment/Productivity Health Economic Questionnaire), current medications, and any adverse events/problems reported. During each six -month follow-up visit with the study doctor, information collected will include observations from physical examination, updates on clinical disease status, Quality of life assessments, medications and adverse events/problems. No study agents will be administered in this registry. All patients will receive standard of care treatments prescribed by the patient's physician.

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Study Type : Observational
Estimated Enrollment : 16000 participants
Observational Model: Cohort
Time Perspective: Prospective
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 : May 31, 2021
Estimated Study Completion Date : December 1, 2029

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Infliximab
Participants will receive infliximab as prescribed by the physician according to standard of care for psoriasis.
Biological: Infliximab
Infliximab will be administered as prescribed by physician.

Ustekinumab
Participants will receive ustekinumab as prescribed by the physician according to standard of care for psoriasis.
Biological: Ustekinumab
Ustekinumab will be administered as prescribed by physician.

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

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

Guselkumab
Participants will receive guselkumab as prescribed by the physician according to standard of care for psoriasis.
Biological: Guselkumab
Guselkumab will be administered as prescribed by physician.




Primary Outcome Measures :
  1. Number of patients with Adverse Events and Serious Adverse Events [ Time Frame: 8 years from last patient enrolled ]
    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. All adverse events, including those of special interest, such as dysplasias and malignancies of all types, serious infections, and new autoimmune disease, will be documented.


Secondary Outcome Measures :
  1. Physician reported plaque psoriasis and psoriatic arthritis (PsA) Score [ Time Frame: every 6 months for 8 years ]
  2. Dermatology Life Quality Index (DLQI) Score [ Time Frame: every 6 months for 8 years ]
  3. EuroQOL quality of life assessment [ Time Frame: every 6 months for 8 years ]
  4. Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: every 6 months up to Month 18 and then every year up to 8 years ]
  5. Percentage of patients being treated that meets labeling criteria [ Time Frame: every 6 months for 8 years ]
  6. Percentage of participants with comorbidities: cardiovascular disease [ Time Frame: Day 1 ]
  7. Percentage of participants with comorbidities: malignancy [ Time Frame: Day 1 ]
  8. Burden of Disease: Body surface area [ Time Frame: every 6 months for 8 years ]
  9. Burden of Disease: Psoriasis Area and Severity Index (PASI) Score [ Time Frame: every 6 months for 8 years ]
  10. Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score [ Time Frame: every 6 months for 8 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 patients with psoriasis that meets the inclusion criteria will be eligible to participate in this registry.
Criteria

Inclusion Criteria:

  • Have a diagnosis of psoriasis
  • Are candidates for, or are currently receiving conventional systemic agents (eg, methotrexate, acitretin, cyclosporine or systemic psoralen drug in combination with Ultraviolet A light [PUVA]) or biologic therapy for psoriasis including those with chronic severe (extensive and/or disabling) plaque psoriasis who may be treated with infliximab or those with moderate to severe plaque psoriasis who may be treated with ustekinumab, guselkumab, or another biologic agent
  • 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 request for a 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 Centocor-sponsored clinical trial with marketed agents

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


Contacts
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Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Show 364 Study Locations
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
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Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC

Additional Information:
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     History of Changes
Other Study ID Numbers: CR013225
PSOLAR ( Other Identifier: Janssen Scientific Affairs, LLC )
First Posted: July 30, 2007    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Scientific Affairs, LLC:
Skin disease
Methotrexate
Acitretin
Cyclosporine
Systemic PUVA
Infliximab
Adalimumab
Alefacept
Efalizumab
Etanercept
Psoriasis
Psoriatic arthritis
Cosentyx

Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spinal Diseases
Bone Diseases
Arthritis
Psoriasis
Arthritis, Psoriatic
Spondylarthropathies
Spondylarthritis
Spondylitis
Infliximab
Ustekinumab
Antibodies, Monoclonal
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs