Psoriasis Longitudinal Assessment and Registry (PSOLAR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier:
NCT00508547
First received: July 27, 2007
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to further evaluate the safety of infliximab and ustekinumab in patients with plaque psoriasis, and other overlapping 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, quality of life, and potential risks for patients who may receive standard therapies for psoriasis.


Condition Intervention Phase
Psoriasis
Arthritis, Psoriatic
Biological: ustekinumab
Biological: Biological therapies other than infliximab and ustekinumab
Drug: conventional systemic agents
Biological: infliximab
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Centocor Ortho Biotech Services, L.L.C.:

Primary Outcome Measures:
  • The primary outcomes are to further evaluate the safety of ustekinumab in patients with moderate to severe plaque psoriasis and to further evaluate the safety of infliximab in patients with chronic severe (extensive and/or disabling) plaque psoriasis. [ Time Frame: 8 years from last patient enrolled ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize disease features in patients exposed to ustekinumab and/or infliximab [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • To evaluate clinical outcomes, quality of life, and comorbidities for patients who may receive conventional systemic or biologic therapy for psoriasis [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • To assess the proportion of patients exposed to ustekinumab who meets labeling criteria relative to the number of patients exposed, based on the data collected within the registry [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • To assess the proportion of patients exposed to infliximab who meets labeling criteria relative to the number of patients exposed, based on the data collected within the registry [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]

Enrollment: 12025
Study Start Date: June 2007
Estimated Study Completion Date: May 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001
infliximab as prescribed
Biological: infliximab
as prescribed
002
ustekinumab as prescribed
Biological: ustekinumab
as prescribed
003
Biological therapies other than infliximab and ustekinumab as prescribed
Biological: Biological therapies other than infliximab and ustekinumab
as prescribed
004
conventional systemic agents as prescribed
Drug: conventional systemic agents
as prescribed

Detailed Description:

PSOLAR is an 8-10 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 and 4000 ustekinumab-exposed patients 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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any patients with psoriasis that meets the inclusion and exclusion 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
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508547

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Locations
United States, Alabama
Birmingham, Alabama, United States
Florence, Alabama, United States
Huntsville, Alabama, United States
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Phoenix, Arizona, United States
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Simferopol, Ukraine
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Sponsors and Collaborators
Centocor Ortho Biotech Services, L.L.C.
Investigators
Study Director: Centocor Ortho Biotech Services, L.L.C. Clinical Trial Centocor Ortho Biotech Services, L.L.C.
  More Information

No publications provided

Responsible Party: Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier: NCT00508547     History of Changes
Other Study ID Numbers: CR013225, PSOLAR
Study First Received: July 27, 2007
Last Updated: August 7, 2014
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee

Keywords provided by Centocor Ortho Biotech Services, L.L.C.:
Methotrexate
Acitretin
Cyclosporine
Systemic PUVA
Infliximab
Adalimumab
Alefacept
Efalizumab
Etanercept
Psoriasis
Psoriatic arthritis
Skin disease

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Psoriasis
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
Antibodies, Monoclonal
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Immunologic Factors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014