Clinical Trials in South Korea / NCT00508547
Active, not recruiting
Observational
Psoriasis Longitudinal Assessment and Registry
NCT00508547 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Psoriasis
Study 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.
Eligibility
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
Primary outcome measure(s)
- Adverse Events and Serious Adverse Events — 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.
Trial sites (320)
| Facility | City | Region | Status |
|---|---|---|---|
| — | Birmingham | Alabama | |
| — | Florence | Alabama | |
| — | Huntsville | Alabama | |
| — | Phoenix | Arizona | |
| — | Scottsdale | Arizona | |
| — | Tucson | Arizona | |
| — | Rogers | Arkansas | |
| — | Bakersfield | California | |
| — | Clovis | California | |
| — | Fountain Valley | California | |
| — | Fresno | California | |
| — | Loma Linda | California | |
| — | Los Angeles | California | |
| — | Mountain View | California | |
| — | Oxnard | California | |
| — | Redding | California | |
| — | Rolling Hills Estates | California | |
| — | San Diego | California | |
| — | San Ramon | California | |
| — | Santa Monica | California | |
| — | Sherman Oaks | California | |
| — | Upland | California | |
| — | Vallejo | California | |
| — | Colorado Springs | Colorado | |
| — | Englewood | Colorado | |
| — | Bridgeport | Connecticut | |
| — | Farmington | Connecticut | |
| — | Newark | Delaware | |
| — | Wilmington | Delaware | |
| — | Washington D.C. | District of Columbia | |
| — | Aventura | Florida | |
| — | Bay Pines | Florida | |
| — | Boca Raton | Florida | |
| — | Boynton Beach | Florida | |
| — | Coral Gables | Florida | |
| — | Delray Beach | Florida | |
| — | Dunedin | Florida | |
| — | Hollywood | Florida | |
| — | Jacksonville | Florida | |
| — | Melbourne | Florida |
+ 280 more sites — see the full list on the official registry below.
Other trials for the same condition
Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT00508547 on ClinicalTrials.gov ↗ ← All trials in South Korea