Psoriasis Longitudinal Assessment and Registry

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT00508547
• Date of registration: 27/07/2007
• Prospective Registration: No
• Primary sponsor: Janssen Scientific Affairs, LLC
• Public title: Psoriasis Longitudinal Assessment and Registry PSOLAR
• Scientific title: A Multicenter, Open Registry of Patients With Plaque Psoriasis Who Are Candidates for Systemic Therapy Including Biologics
• Date of first enrolment: June 21, 2007
• Target sample size: 15834
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT00508547
• Study type: Observational [Patient Registry]

Countries of recruitment

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

Contacts

• Name: Janssen Scientific Affairs, LLC Clinical Trial
• Affiliation: Janssen Scientific Affairs, LLC

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Psoriasis

Primary Outcome(s)

Adverse Events and Serious Adverse Events [Time Frame: Up to 8 years of follow up for each patient]

Secondary Outcome(s)

EuroQOL quality of life assessment [Time Frame: At baseline and every 6 months through up to 8 years]

Dermatology Life Quality Index (DLQI) Score [Time Frame: At baseline and every 6 months through up to 8 years]

Evaluation of Disease Features: Body surface area [Time Frame: At baseline and every 6 months through up to 8 years]

Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score [Time Frame: At baseline and every 6 months through up to 8 years]

Evaluation of Disease Features: Psoriasis Area and Severity Index (PASI) Score [Time Frame: At baseline and every 6 months through up to 8 years]

Hospital Anxiety and Depression Scale (HADS) Score [Time Frame: At baseline and every 6 months up to Month 18 and then every year up to 8 years]

Secondary ID(s)

PSOLAR

CR013225

Source(s) of Monetary Support

Please refer to primary and secondary sponsors