A Study to Provide Real-world Evidence on the Treatment Goal Achievement Rate, Adherence to and Utilization Patterns of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in Greece (CONCORDIA)

AbbVie

Status: Completed

Conditions: Moderate to Severe Plaque Psoriasis

Study type: Observational

Funder types: Industry

Identifiers

NCT02713295

P15-693

Details and patient eligibility

About

This study estimates the treatment goal achievement rate, depicts the implementation of the Progressive Psoriasis Initiative (PPI) recommendations regarding treatment modifications and transitioning, and assesses patient adherence and persistence with adalimumab therapy in the routine clinical practice in Greece.

Enrollment: 273 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of plaque psoriasis for at least 6 months, and moderate to severe disease course at the time of adalimumab treatment onset, defined as Body Surface Area (BSA) >10 or PASI >10 and DLQI >10
• Patients for whom the decision to prescribe therapy with adalimumab (Humira®) according to the locally approved summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study
• Patients with an available Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores at the start of adalimumab treatment
• Patients able and willing to provide written informed consent and to comply with the requirements of this study protocol
• Patients with a signed informed consent document

Exclusion criteria

• Patients should not have non-plaque forms of psoriasis (e.g., erythrodermic, guttate, or pustular)
• Patients for whom treatment with adalimumab has been initiated more than 2 weeks prior to their enrolment into the study
• Patients that meet any of the contraindications to the administration of the study drug according to the latest version of the locally approved SmPC
• Patients who have previously been exposed to adalimumab unless a period of at least 6 months from the last dose has elapsed
• Patients currently receiving treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with adalimumab.

Trial design

273 participants in 1 patient group

Subjects with Moderate to Severe Plaque Psoriasis

Description:

Subjects with Moderate to Severe Plaque Psoriasis in Greece