Psoriasis Longitudinal Assessment and Registry (PSOLAR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT00508547
First received: July 27, 2007
Last updated: June 6, 2016
Last verified: June 2016
  Purpose
The purpose of this study is to further evaluate the safety of infliximab and ustekinumab 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 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 Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • Number of patients with Adverse Events and Serious Adverse Events [ Time Frame: 8 years from last patient enrolled ] [ Designated as safety issue: Yes ]
    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:
  • Physician reported plaque psoriasis and psoriatic arthritis (PsA) Score [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • Dermatology Life Quality Index (DLQI) Score [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • EuroQOL quality of life assessment [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: every 6 months up to Month 18 and then every year up to 8 years ] [ Designated as safety issue: No ]
  • Percentage of patients being treated that meets labeling criteria [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • Percentage of participants with comorbidities: cardiovascular disease [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Percentage of participants with comorbidities: malignancy [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Burden of Disease: Body surface area [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • Burden of Disease: Psoriasis Area and Severity Index (PASI) Score [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]

Enrollment: 12052
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 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 2000 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 to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  • 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

  Show 268 Study Locations
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00508547     History of Changes
Other Study ID Numbers: CR013225  PSOLAR 
Study First Received: July 27, 2007
Last Updated: June 6, 2016
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Arthritis
Psoriasis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Infliximab
Ustekinumab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 28, 2016