Psoriasis Longitudinal Assessment and Registry

NCT ID: NCT00508547

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

15842 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-21

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psoriasis

Keywords

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psoriasis psoriatic arthritis skin disease infliximab ustekinumab guselkumab etanercept adalimumab secukinumab ixekizumab brodalumab systemic therapy observational registry

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Guselkumab

Participants will receive guselkumab as prescribed by a physician according to standard of care for psoriasis.

No interventions assigned to this group

Infliximab

Participants will receive infliximab as prescribed by a physician according to standard of care for psoriasis.

No interventions assigned to this group

Ustekinumab

Participants will receive ustekinumab as prescribed by a physician according to standard of care for psoriasis.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

IL-17 Inhibitor

Participants will receive an IL-17 inhibitor as prescribed by a physician according to standard of care for psoriasis.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Scientific Affairs, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Scientific Affairs, LLC

Locations

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Birmingham, Alabama, United States

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Florence, Alabama, United States

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Huntsville, Alabama, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Rogers, Arkansas, United States

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Bakersfield, California, United States

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Clovis, California, United States

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Fountain Valley, California, United States

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Fresno, California, United States

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Loma Linda, California, United States

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Los Angeles, California, United States

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Mountain View, California, United States

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Oxnard, California, United States

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Redding, California, United States

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Rolling Hills Estates, California, United States

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San Diego, California, United States

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San Ramon, California, United States

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Santa Monica, California, United States

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Sherman Oaks, California, United States

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Upland, California, United States

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Vallejo, California, United States

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Colorado Springs, Colorado, United States

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Englewood, Colorado, United States

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Bridgeport, Connecticut, United States

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Farmington, Connecticut, United States

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Newark, Delaware, United States

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Wilmington, Delaware, United States

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Washington D.C., District of Columbia, United States

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Aventura, Florida, United States

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Bay Pines, Florida, United States

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Boca Raton, Florida, United States

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Boynton Beach, Florida, United States

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Coral Gables, Florida, United States

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Delray Beach, Florida, United States

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Dunedin, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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North Miami Beach, Florida, United States

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Panama City, Florida, United States

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Pembroke Pines, Florida, United States

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Seminole, Florida, United States

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Tampa, Florida, United States

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Alpharetta, Georgia, United States

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Atlanta, Georgia, United States

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Birmingham, Georgia, United States

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Carrollton, Georgia, United States

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Conyers, Georgia, United States

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Lilburn, Georgia, United States

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Macon, Georgia, United States

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Marietta, Georgia, United States

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Rome, Georgia, United States

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Twin Falls, Idaho, United States

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Champaign, Illinois, United States

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Chicago, Illinois, United States

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Lincolnshire, Illinois, United States

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Maywood, Illinois, United States

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Rolling Meadows, Illinois, United States

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Schaumburg, Illinois, United States

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Skokie, Illinois, United States

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Springfield, Illinois, United States

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West Dundee, Illinois, United States

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Winfield, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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New Albany, Indiana, United States

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Plainfield, Indiana, United States

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West Lafayette, Indiana, United States

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Topeka, Kansas, United States

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Corbin, Kentucky, United States

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Lexington, Kentucky, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Quincy, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Clarkston, Michigan, United States

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Clinton Township, Michigan, United States

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Farmington, Michigan, United States

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Flint, Michigan, United States

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Fort Gratiot, Michigan, United States

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Grand Blanc, Michigan, United States

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Grand Rapids, Michigan, United States

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Monroe, Michigan, United States

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Norton Shores, Michigan, United States

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Troy, Michigan, United States

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Warren, Michigan, United States

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Eagan, Minnesota, United States

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Chesterfield, Missouri, United States

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St Louis, Missouri, United States

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Helena, Montana, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Lebanon, New Hampshire, United States

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Nashua, New Hampshire, United States

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Belleville, New Jersey, United States

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East Windsor, New Jersey, United States

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Hoboken, New Jersey, United States

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Marlton, New Jersey, United States

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Rutherford, New Jersey, United States

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Somerset, New Jersey, United States

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Verona, New Jersey, United States

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Wyckoff, New Jersey, United States

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Auburn, New York, United States

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Commack, New York, United States

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East Syracuse, New York, United States

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Elmhurst, New York, United States

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Garden City, New York, United States

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Huntington, New York, United States

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Lawrence, New York, United States

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New York, New York, United States

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Oceanside, New York, United States

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Rochester, New York, United States

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Smithtown, New York, United States

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Staten Island, New York, United States

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Stony Brook, New York, United States

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Suffern, New York, United States

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Syracuse, New York, United States

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The Bronx, New York, United States

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White Plains, New York, United States

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Williamsville, New York, United States

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Chapel Hill, North Carolina, United States

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Raleigh, North Carolina, United States

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Rocky Mount, North Carolina, United States

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Wilmington, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Delaware, Ohio, United States

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Gahanna, Ohio, United States

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Warren, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Coos Bay, Oregon, United States

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Portland, Oregon, United States

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Exton, Pennsylvania, United States

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Fort Washington, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Plymouth Meeting, Pennsylvania, United States

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Charleston, South Carolina, United States

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Fort Mill, South Carolina, United States

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Piedmont, South Carolina, United States

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Spartanburg, South Carolina, United States

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Bartlett, Tennessee, United States

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Bristol, Tennessee, United States

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Kingsport, Tennessee, United States

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Arlington, Texas, United States

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Cedar Hill, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Longview, Texas, United States

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Salt Lake City, Utah, United States

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Arlington, Virginia, United States

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Norfolk, Virginia, United States

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Kennewick, Washington, United States

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Mount Vernon, Washington, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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University Place, Washington, United States

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Walla Walla, Washington, United States

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Green Bay, Wisconsin, United States

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Pleasant Prairie, Wisconsin, United States

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Sheboygan, Wisconsin, United States

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Buenos Aires, , Argentina

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CABA, , Argentina

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Cipolletti, , Argentina

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Lomas de Zamora, , Argentina

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San Miguel, , Argentina

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Fremantle, , Australia

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Melbourne, , Australia

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Miranda, , Australia

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Sydney, , Australia

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Woolloongabba, , Australia

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Althofen, , Austria

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Feldkirch, , Austria

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Graz, , Austria

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Klagenfurt, , Austria

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Laakirchen, , Austria

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Sankt Pölten, , Austria

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Vienna, , Austria

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Villach, , Austria

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Bruges, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Mons, , Belgium

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Nanaimo, British Columbia, Canada

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Surrey, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Fredericton, New Brunswick, Canada

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Moncton, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Kentville, Nova Scotia, Canada

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Barrie, Ontario, Canada

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Coburg, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Hamilton, Ontario, Canada

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Kingston, Ontario, Canada

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Kitchener, Ontario, Canada

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London, Ontario, Canada

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Markham, Ontario, Canada

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Mississauga, Ontario, Canada

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Newmarket, Ontario, Canada

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North Bay, Ontario, Canada

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Ottawa, Ontario, Canada

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Peterborough, Ontario, Canada

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Saint Catherines, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Drummondville, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Santiago, , Chile

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Santiago - Las Condes, , Chile

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Santiago - Macul, , Chile

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Bogotá, , Colombia

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Medellín, , Colombia

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Brno, , Czechia

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České Budějovice, , Czechia

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Jihlava, , Czechia

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Náchod, , Czechia

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Nový Jičín, , Czechia

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Olomouc, , Czechia

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Pardubice, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Šumperk, , Czechia

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Ústí nad Labem, , Czechia

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Athens, , Greece

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Heraklion, , Greece

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Ioannina, , Greece

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Larissa, , Greece

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Pátrai, , Greece

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Piraeus-Athens, , Greece

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Thessaloniki, , Greece

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Afula, , Israel

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Beersheba, , Israel

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Haifa, , Israel

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Netivot, , Israel

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Petah Tikva, , Israel

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Ramat Gan, , Israel

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Tel Aviv, , Israel

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Hirakata, , Japan

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Hokkaido, , Japan

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Itabashi Ku, , Japan

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Kobe, , Japan

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Kurume, , Japan

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Matsumoto, , Japan

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Ōita, , Japan

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Takamatsu, , Japan

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Tokyo, , Japan

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Tsu, , Japan

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Yokosuka, , Japan

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Estado de México, , Mexico

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Mexico City, , Mexico

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Monterrey, , Mexico

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Zapopan, , Mexico

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Alkmaar, , Netherlands

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Amsterdam-Zuidoost, , Netherlands

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Breda, , Netherlands

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Deventer, , Netherlands

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Helmond, , Netherlands

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Nijmegen, , Netherlands

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Braga, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Vila Nova de Gaia, , Portugal

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Banská Bystrica, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Martin, , Slovakia

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Nitra, , Slovakia

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Poprad, , Slovakia

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Prešov, , Slovakia

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Trnava, , Slovakia

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Celje, , Slovenia

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Izola, , Slovenia

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Kranj, , Slovenia

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Ljubljana, , Slovenia

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Maribor, , Slovenia

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Busan, , South Korea

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Gyeonggi-do, , South Korea

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Seongnam-si, , South Korea

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Seoul, , South Korea

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Sungnam, , South Korea

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Alcalá de Henares, , Spain

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Bilbao, , Spain

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Granada, , Spain

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Madrid, , Spain

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Majadahonda, , Spain

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Murcia, , Spain

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Salamanca, , Spain

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Santiago de Compostela, , Spain

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Eskilstuna, , Sweden

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Gothenburg, , Sweden

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Kungsbacka, , Sweden

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Stockholm, , Sweden

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Taoyuan, , Taiwan

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Dnipro, , Ukraine

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Donetsk, , Ukraine

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Kharkiv, , Ukraine

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Khmelnitskiy, , Ukraine

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Kiev, , Ukraine

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Luhansk, , Ukraine

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Simferopol, , Ukraine

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Uzhhorod, , Ukraine

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Countries

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Brazil Italy United States Argentina Australia Austria Belgium Canada Chile Colombia Czechia Greece Israel Japan Mexico Netherlands Portugal Slovakia Slovenia South Korea Spain Sweden Taiwan Ukraine

References

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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.

Reference Type DERIVED
PMID: 31799498 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30886979 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30267377 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26853180 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25970800 (View on PubMed)

Other Identifiers

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C0168Z03

Identifier Type: OTHER

Identifier Source: secondary_id

CR013225

Identifier Type: -

Identifier Source: org_study_id